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Researchers eye cannabis for gynecologic pain
Many women use cannabis to help manage gynecologic pain conditions.
When patients ask or tell clinicians about this treatment approach, however, few if any controlled trials exist to inform medical guidance.
A recent review of studies in this area presents a “thorough analysis of this very relevant topic,” said Erin A. Blake, MD, of Presbyterian Cancer Care, Rio Rancho, N.M..
The findings “are consistent with my anecdotal clinical findings as well as the results of my own research,” Dr. Blake said. “Cannabis products represent an underutilized but likely effective modality to relieve pain and other symptoms experienced by our patients.”
Mostly in the dark
Cannabis products “are unregulated and the data we have surrounding them is extremely limited due to outdated federal laws,” said Dr. Blake, who in 2019 described nonprescription cannabis use for symptom management by women with gynecologic malignancies. “Our ability to practice evidence-based medicine related to cannabis products will be limited until we are legally and financially able to design trials to evaluate them in a controlled fashion.”
For the new review, Jenell S. Coleman, MD, MPH, with Johns Hopkins University, Baltimore, and colleagues, identified 16 studies since 1990, including Dr. Blake’s, that examined the use of cannabinoids for managing pain from gynecologic conditions.
Dr. Coleman and her coauthors, Angela L. Liang and Erin L. Gingher, analyzed eight cross-sectional studies, six prospective studies, and two randomized controlled trials.
Patients who used cannabis tended to do so “multiple times per week, and they used a variety of delivery methods and a wide range of doses,” the authors said. “One of the most common reasons for cannabis use was pain management, and all the cross-sectional studies found that most women reported pain relief with cannabis use, especially among women who used a combination of CBD plus THC compared with either cannabinoid alone.”
Cross-sectional studies included patients with chronic pelvic pain (in two of the studies), vulvodynia (one), endometriosis (four), and gynecologic malignancy (two). These studies included between 36 and 3,426 participants and were conducted in the United States, Canada, Australia, and New Zealand.
In one Australian study, for example, Armour and colleagues asked 484 patients with endometriosis to rate the effectiveness of self-management strategies, including cannabis, heat, diet, and exercise, for reducing pelvic pain. Cannabis was used by 13% of the participants and had the highest average effectiveness rating: 7.6 on a 10-point scale.
In some cases, patients who use cannabis may decrease their use of other pain medications, the review found.
Cannabis side effects may include dry mouth, sleepiness, increased appetite, palpitations, and a “high” associated with THC.
Enhancing endogenous cannabinoids
The six prospective cohort studies and two randomized controlled trials examined the effectiveness of compounds – including palmitoylethanolamide (PEA) and a fatty acid amide hydrolase inhibitor – that can enhance endogenous cannabinoids.
Studies of PEA combined with antioxidants showed that these treatments significantly decreased pain from primary dysmenorrhea, pelvic pain, and interstitial cystitis. PEA-combination medications were well tolerated, with nausea and spotting as potential side effects.
On the other hand, a study that assessed a fatty acid amide hydrolase inhibitor found that it did not decrease pain from interstitial cystitis.
Dr. Coleman began reviewing the endocannabinoid system and cannabis research after hearing from patients who were using cannabis for pelvic pain.
Seeing various preclinical data that suggest cannabis could be useful for pain conditions came as a surprise.
Still, the existing evidence base for clinical effectiveness is poor quality, Dr. Coleman said in an interview. Rigorous trials are needed.
“It is a whole field that is just waiting for the U.S. to do something in terms of legalization so that we can actually study to see, does this make sense?” Dr. Coleman said.
Cannabis should not be used while pregnant
In a recent meta-analysis based on data from nearly 60,000 individuals, women who used marijuana during pregnancy were at increased risk for adverse neonatal outcomes such as low birth weight and preterm birth. Study author Greg J. Marchand, MD, of the Marchand Institute for Minimally Invasive Surgery, Mesa, Ariz., noted that the results will force some difficult decisions for mothers who use marijuana to treat medical problems, and that there may not be good substitute treatments for some of these conditions, especially chronic pain and anxiety.
Dr. Coleman disclosed investments in a cannabis exchange-traded fund. Dr. Blake and Dr. Marchand had no relevant financial disclosures.
Many women use cannabis to help manage gynecologic pain conditions.
When patients ask or tell clinicians about this treatment approach, however, few if any controlled trials exist to inform medical guidance.
A recent review of studies in this area presents a “thorough analysis of this very relevant topic,” said Erin A. Blake, MD, of Presbyterian Cancer Care, Rio Rancho, N.M..
The findings “are consistent with my anecdotal clinical findings as well as the results of my own research,” Dr. Blake said. “Cannabis products represent an underutilized but likely effective modality to relieve pain and other symptoms experienced by our patients.”
Mostly in the dark
Cannabis products “are unregulated and the data we have surrounding them is extremely limited due to outdated federal laws,” said Dr. Blake, who in 2019 described nonprescription cannabis use for symptom management by women with gynecologic malignancies. “Our ability to practice evidence-based medicine related to cannabis products will be limited until we are legally and financially able to design trials to evaluate them in a controlled fashion.”
For the new review, Jenell S. Coleman, MD, MPH, with Johns Hopkins University, Baltimore, and colleagues, identified 16 studies since 1990, including Dr. Blake’s, that examined the use of cannabinoids for managing pain from gynecologic conditions.
Dr. Coleman and her coauthors, Angela L. Liang and Erin L. Gingher, analyzed eight cross-sectional studies, six prospective studies, and two randomized controlled trials.
Patients who used cannabis tended to do so “multiple times per week, and they used a variety of delivery methods and a wide range of doses,” the authors said. “One of the most common reasons for cannabis use was pain management, and all the cross-sectional studies found that most women reported pain relief with cannabis use, especially among women who used a combination of CBD plus THC compared with either cannabinoid alone.”
Cross-sectional studies included patients with chronic pelvic pain (in two of the studies), vulvodynia (one), endometriosis (four), and gynecologic malignancy (two). These studies included between 36 and 3,426 participants and were conducted in the United States, Canada, Australia, and New Zealand.
In one Australian study, for example, Armour and colleagues asked 484 patients with endometriosis to rate the effectiveness of self-management strategies, including cannabis, heat, diet, and exercise, for reducing pelvic pain. Cannabis was used by 13% of the participants and had the highest average effectiveness rating: 7.6 on a 10-point scale.
In some cases, patients who use cannabis may decrease their use of other pain medications, the review found.
Cannabis side effects may include dry mouth, sleepiness, increased appetite, palpitations, and a “high” associated with THC.
Enhancing endogenous cannabinoids
The six prospective cohort studies and two randomized controlled trials examined the effectiveness of compounds – including palmitoylethanolamide (PEA) and a fatty acid amide hydrolase inhibitor – that can enhance endogenous cannabinoids.
Studies of PEA combined with antioxidants showed that these treatments significantly decreased pain from primary dysmenorrhea, pelvic pain, and interstitial cystitis. PEA-combination medications were well tolerated, with nausea and spotting as potential side effects.
On the other hand, a study that assessed a fatty acid amide hydrolase inhibitor found that it did not decrease pain from interstitial cystitis.
Dr. Coleman began reviewing the endocannabinoid system and cannabis research after hearing from patients who were using cannabis for pelvic pain.
Seeing various preclinical data that suggest cannabis could be useful for pain conditions came as a surprise.
Still, the existing evidence base for clinical effectiveness is poor quality, Dr. Coleman said in an interview. Rigorous trials are needed.
“It is a whole field that is just waiting for the U.S. to do something in terms of legalization so that we can actually study to see, does this make sense?” Dr. Coleman said.
Cannabis should not be used while pregnant
In a recent meta-analysis based on data from nearly 60,000 individuals, women who used marijuana during pregnancy were at increased risk for adverse neonatal outcomes such as low birth weight and preterm birth. Study author Greg J. Marchand, MD, of the Marchand Institute for Minimally Invasive Surgery, Mesa, Ariz., noted that the results will force some difficult decisions for mothers who use marijuana to treat medical problems, and that there may not be good substitute treatments for some of these conditions, especially chronic pain and anxiety.
Dr. Coleman disclosed investments in a cannabis exchange-traded fund. Dr. Blake and Dr. Marchand had no relevant financial disclosures.
Many women use cannabis to help manage gynecologic pain conditions.
When patients ask or tell clinicians about this treatment approach, however, few if any controlled trials exist to inform medical guidance.
A recent review of studies in this area presents a “thorough analysis of this very relevant topic,” said Erin A. Blake, MD, of Presbyterian Cancer Care, Rio Rancho, N.M..
The findings “are consistent with my anecdotal clinical findings as well as the results of my own research,” Dr. Blake said. “Cannabis products represent an underutilized but likely effective modality to relieve pain and other symptoms experienced by our patients.”
Mostly in the dark
Cannabis products “are unregulated and the data we have surrounding them is extremely limited due to outdated federal laws,” said Dr. Blake, who in 2019 described nonprescription cannabis use for symptom management by women with gynecologic malignancies. “Our ability to practice evidence-based medicine related to cannabis products will be limited until we are legally and financially able to design trials to evaluate them in a controlled fashion.”
For the new review, Jenell S. Coleman, MD, MPH, with Johns Hopkins University, Baltimore, and colleagues, identified 16 studies since 1990, including Dr. Blake’s, that examined the use of cannabinoids for managing pain from gynecologic conditions.
Dr. Coleman and her coauthors, Angela L. Liang and Erin L. Gingher, analyzed eight cross-sectional studies, six prospective studies, and two randomized controlled trials.
Patients who used cannabis tended to do so “multiple times per week, and they used a variety of delivery methods and a wide range of doses,” the authors said. “One of the most common reasons for cannabis use was pain management, and all the cross-sectional studies found that most women reported pain relief with cannabis use, especially among women who used a combination of CBD plus THC compared with either cannabinoid alone.”
Cross-sectional studies included patients with chronic pelvic pain (in two of the studies), vulvodynia (one), endometriosis (four), and gynecologic malignancy (two). These studies included between 36 and 3,426 participants and were conducted in the United States, Canada, Australia, and New Zealand.
In one Australian study, for example, Armour and colleagues asked 484 patients with endometriosis to rate the effectiveness of self-management strategies, including cannabis, heat, diet, and exercise, for reducing pelvic pain. Cannabis was used by 13% of the participants and had the highest average effectiveness rating: 7.6 on a 10-point scale.
In some cases, patients who use cannabis may decrease their use of other pain medications, the review found.
Cannabis side effects may include dry mouth, sleepiness, increased appetite, palpitations, and a “high” associated with THC.
Enhancing endogenous cannabinoids
The six prospective cohort studies and two randomized controlled trials examined the effectiveness of compounds – including palmitoylethanolamide (PEA) and a fatty acid amide hydrolase inhibitor – that can enhance endogenous cannabinoids.
Studies of PEA combined with antioxidants showed that these treatments significantly decreased pain from primary dysmenorrhea, pelvic pain, and interstitial cystitis. PEA-combination medications were well tolerated, with nausea and spotting as potential side effects.
On the other hand, a study that assessed a fatty acid amide hydrolase inhibitor found that it did not decrease pain from interstitial cystitis.
Dr. Coleman began reviewing the endocannabinoid system and cannabis research after hearing from patients who were using cannabis for pelvic pain.
Seeing various preclinical data that suggest cannabis could be useful for pain conditions came as a surprise.
Still, the existing evidence base for clinical effectiveness is poor quality, Dr. Coleman said in an interview. Rigorous trials are needed.
“It is a whole field that is just waiting for the U.S. to do something in terms of legalization so that we can actually study to see, does this make sense?” Dr. Coleman said.
Cannabis should not be used while pregnant
In a recent meta-analysis based on data from nearly 60,000 individuals, women who used marijuana during pregnancy were at increased risk for adverse neonatal outcomes such as low birth weight and preterm birth. Study author Greg J. Marchand, MD, of the Marchand Institute for Minimally Invasive Surgery, Mesa, Ariz., noted that the results will force some difficult decisions for mothers who use marijuana to treat medical problems, and that there may not be good substitute treatments for some of these conditions, especially chronic pain and anxiety.
Dr. Coleman disclosed investments in a cannabis exchange-traded fund. Dr. Blake and Dr. Marchand had no relevant financial disclosures.
FROM OBSTETRICS & GYNECOLOGY
Vitamin D shows no survival benefit in nondeficient elderly
, including mortality linked to cardiovascular disease, new results from a large, placebo-controlled trial show.
“The take-home message is that routine vitamin D supplementation, irrespective of the dosing regimen, is unlikely to be beneficial in a population with a low prevalence of vitamin D deficiency,” first author Rachel E. Neale, PhD, of the Population Health Department, QIMR Berghofer Medical Research Institute, in Brisbane, Australia, told this news organization.
Despite extensive previous research on vitamin D supplementation, “mortality has not been the primary outcome in any previous large trial of high-dose vitamin D supplementation,” Dr. Neale and coauthors noted. The results, published online in Lancet Diabetes & Endocrinology, are from the D-Health trial.
With more than 20,000 participants, this is the largest intermittent-dosing trial to date, the authors noted. The primary outcome was all-cause mortality.
In an accompanying editorial, Inez Schoenmakers, PhD, noted that “the findings [are] highly relevant for population policy, owing to the study’s population-based design, large scale, and long duration.”
This new “research contributes to the concept that improving vitamin D status with supplementation in a mostly vitamin D-replete older population does not influence all-cause mortality,” Dr. Schoenmakers, of the Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, England, said in an interview.
“This is not dissimilar to research with many other nutrients showing that increasing intake above the adequate intake has no further health benefits,” she added.
D-Health Trial
The D-Health Trial involved 21,315 participants in Australia, enrolled between February 2014 and June 2015, who had not been screened for vitamin D deficiency but were largely considered to be vitamin D replete. They were a mean age of 69.3 years and 54% were men.
Participants were randomized 1:1 to a once-monthly oral vitamin D3 supplementation of 60,000 IU (n = 10,662) or a placebo capsule (n = 10,653).
They were permitted to take up to 2,000 IU/day of supplemental vitamin D in addition to the study protocol and had no history of kidney stones, hypercalcemia, hyperparathyroidism, osteomalacia, or sarcoidosis.
Over a median follow-up of 5.7 years, there were 1,100 deaths: 562 in the vitamin D group (5.3%) and 538 in the placebo group (5.1%). With a hazard ratio (HR) for all-cause mortality of 1.04, the difference was not significant (P = .47).
There were also no significant differences in terms of mortality from cardiovascular disease (HR, 0.96; P = .77), cancer (HR, 1.15; P = .13), or other causes (HR, 0.83; P = .15).
Rates of total adverse events between the two groups, including hypercalcemia and kidney stones, were similar.
An exploratory analysis excluding the first 2 years of follow-up in fact showed a numerically higher hazard ratio for cancer mortality in the vitamin D group versus no supplementation (HR, 1.24; P = .05). However, the authors noted that the effect was “not apparent when the analysis was restricted to deaths that were coded by the study team and not officially coded.”
Nevertheless, “our findings, from a large study in an unscreened population, give pause to earlier reports that vitamin D supplements might reduce cancer mortality,” they underscored.
Retention and adherence in the study were high, each exceeding 80%. Although blood samples were not collected at baseline, samples from 3,943 randomly sampled participants during follow-up showed mean serum 25-hydroxy-vitamin D concentrations of 77 nmol/L in the placebo group and 115 nmol/L in the vitamin D group, both within the normal range of 50-125 nmol/L.
Findings supported by previous research
The trial results are consistent with those of prior large studies and meta-analyses of older adults with a low prevalence of vitamin D deficiency showing that vitamin D3 supplementation, regardless of whether taken daily or monthly, is not likely to have an effect on all-cause mortality.
In the US VITAL trial, recently published in the New England Journal of Medicine, among 25,871 participants administered 2,000 IU/day of vitamin D3 for a median of 5.3 years, there was no reduction in all-cause mortality.
The ViDA trial of 5,110 older adults in New Zealand, published in 2019 in the Journal of Endocrinological Investigation, also showed monthly vitamin D3 supplementation of 100,000 IU for a median of 3.3 years was not associated with a benefit in people who were not deficient.
“In total, the results from the large trials and meta-analyses suggest that routine supplementation of older adults in populations with a low prevalence of vitamin D deficiency is unlikely to reduce the rate of all-cause mortality,” Dr. Neale and colleagues concluded.
Longer-term supplementation beneficial?
The population was limited to older adults and the study had a relatively short follow-up period, which Dr. Neale noted was necessary for pragmatic reasons.
“Our primary outcome was all-cause mortality, so to have sufficient deaths we either needed to study older adults or a much larger sample of younger adults,” she explained.
“However, we felt that [the former] ... had biological justification, as there is evidence that vitamin D plays a role later in the course of a number of diseases, with potential impacts on mortality.”
She noted that recent studies evaluating genetically predicted concentrations of serum 25(OH)D have further shown no link between those levels and all-cause mortality, stroke, or coronary heart disease.
“This confirms the statement that vitamin D is unlikely to be beneficial in people who are not vitamin D deficient, irrespective of whether supplementation occurs over the short or longer term,” Dr. Neale said.
The source of vitamin D, itself, is another consideration, with ongoing speculation of differences in benefits between dietary or supplementation sources versus sunlight exposure.
“Exposure to ultraviolet radiation, for which serum 25(OH)D concentration is a good marker, might confer benefits not mediated by vitamin D,” Dr. Neale and coauthors noted.
They added that the results in the older Australian population “cannot be generalized to populations with a higher prevalence of vitamin D deficiency, or with a greater proportion of people not of White ancestry, than the study population.”
Ten-year mortality rates from the D-Health trial are expected to be reported in the future.
Strategies still needed to address vitamin D deficiency
Further commenting on the findings, Dr. Schoenmakers underscored that “vitamin D deficiency is very common worldwide, [and] more should be done to develop strategies to address the needs of those groups and populations that are at risk of the consequences of vitamin D deficiency.”
That said, the D-Health study is important in helping to distinguish when supplementation may – and may not – be of benefit, she noted.
“This and other research in the past 15 years have contributed to our understanding [of] what the ranges of vitamin D status are [in which] health consequences may be anticipated.”
The D-Health Trial was funded by the National Health and Medical Research Council. Dr. Neale and Dr. Schoenmakers have reported no relevant financial relationships.
version of this article first appeared on Medscape.com.
, including mortality linked to cardiovascular disease, new results from a large, placebo-controlled trial show.
“The take-home message is that routine vitamin D supplementation, irrespective of the dosing regimen, is unlikely to be beneficial in a population with a low prevalence of vitamin D deficiency,” first author Rachel E. Neale, PhD, of the Population Health Department, QIMR Berghofer Medical Research Institute, in Brisbane, Australia, told this news organization.
Despite extensive previous research on vitamin D supplementation, “mortality has not been the primary outcome in any previous large trial of high-dose vitamin D supplementation,” Dr. Neale and coauthors noted. The results, published online in Lancet Diabetes & Endocrinology, are from the D-Health trial.
With more than 20,000 participants, this is the largest intermittent-dosing trial to date, the authors noted. The primary outcome was all-cause mortality.
In an accompanying editorial, Inez Schoenmakers, PhD, noted that “the findings [are] highly relevant for population policy, owing to the study’s population-based design, large scale, and long duration.”
This new “research contributes to the concept that improving vitamin D status with supplementation in a mostly vitamin D-replete older population does not influence all-cause mortality,” Dr. Schoenmakers, of the Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, England, said in an interview.
“This is not dissimilar to research with many other nutrients showing that increasing intake above the adequate intake has no further health benefits,” she added.
D-Health Trial
The D-Health Trial involved 21,315 participants in Australia, enrolled between February 2014 and June 2015, who had not been screened for vitamin D deficiency but were largely considered to be vitamin D replete. They were a mean age of 69.3 years and 54% were men.
Participants were randomized 1:1 to a once-monthly oral vitamin D3 supplementation of 60,000 IU (n = 10,662) or a placebo capsule (n = 10,653).
They were permitted to take up to 2,000 IU/day of supplemental vitamin D in addition to the study protocol and had no history of kidney stones, hypercalcemia, hyperparathyroidism, osteomalacia, or sarcoidosis.
Over a median follow-up of 5.7 years, there were 1,100 deaths: 562 in the vitamin D group (5.3%) and 538 in the placebo group (5.1%). With a hazard ratio (HR) for all-cause mortality of 1.04, the difference was not significant (P = .47).
There were also no significant differences in terms of mortality from cardiovascular disease (HR, 0.96; P = .77), cancer (HR, 1.15; P = .13), or other causes (HR, 0.83; P = .15).
Rates of total adverse events between the two groups, including hypercalcemia and kidney stones, were similar.
An exploratory analysis excluding the first 2 years of follow-up in fact showed a numerically higher hazard ratio for cancer mortality in the vitamin D group versus no supplementation (HR, 1.24; P = .05). However, the authors noted that the effect was “not apparent when the analysis was restricted to deaths that were coded by the study team and not officially coded.”
Nevertheless, “our findings, from a large study in an unscreened population, give pause to earlier reports that vitamin D supplements might reduce cancer mortality,” they underscored.
Retention and adherence in the study were high, each exceeding 80%. Although blood samples were not collected at baseline, samples from 3,943 randomly sampled participants during follow-up showed mean serum 25-hydroxy-vitamin D concentrations of 77 nmol/L in the placebo group and 115 nmol/L in the vitamin D group, both within the normal range of 50-125 nmol/L.
Findings supported by previous research
The trial results are consistent with those of prior large studies and meta-analyses of older adults with a low prevalence of vitamin D deficiency showing that vitamin D3 supplementation, regardless of whether taken daily or monthly, is not likely to have an effect on all-cause mortality.
In the US VITAL trial, recently published in the New England Journal of Medicine, among 25,871 participants administered 2,000 IU/day of vitamin D3 for a median of 5.3 years, there was no reduction in all-cause mortality.
The ViDA trial of 5,110 older adults in New Zealand, published in 2019 in the Journal of Endocrinological Investigation, also showed monthly vitamin D3 supplementation of 100,000 IU for a median of 3.3 years was not associated with a benefit in people who were not deficient.
“In total, the results from the large trials and meta-analyses suggest that routine supplementation of older adults in populations with a low prevalence of vitamin D deficiency is unlikely to reduce the rate of all-cause mortality,” Dr. Neale and colleagues concluded.
Longer-term supplementation beneficial?
The population was limited to older adults and the study had a relatively short follow-up period, which Dr. Neale noted was necessary for pragmatic reasons.
“Our primary outcome was all-cause mortality, so to have sufficient deaths we either needed to study older adults or a much larger sample of younger adults,” she explained.
“However, we felt that [the former] ... had biological justification, as there is evidence that vitamin D plays a role later in the course of a number of diseases, with potential impacts on mortality.”
She noted that recent studies evaluating genetically predicted concentrations of serum 25(OH)D have further shown no link between those levels and all-cause mortality, stroke, or coronary heart disease.
“This confirms the statement that vitamin D is unlikely to be beneficial in people who are not vitamin D deficient, irrespective of whether supplementation occurs over the short or longer term,” Dr. Neale said.
The source of vitamin D, itself, is another consideration, with ongoing speculation of differences in benefits between dietary or supplementation sources versus sunlight exposure.
“Exposure to ultraviolet radiation, for which serum 25(OH)D concentration is a good marker, might confer benefits not mediated by vitamin D,” Dr. Neale and coauthors noted.
They added that the results in the older Australian population “cannot be generalized to populations with a higher prevalence of vitamin D deficiency, or with a greater proportion of people not of White ancestry, than the study population.”
Ten-year mortality rates from the D-Health trial are expected to be reported in the future.
Strategies still needed to address vitamin D deficiency
Further commenting on the findings, Dr. Schoenmakers underscored that “vitamin D deficiency is very common worldwide, [and] more should be done to develop strategies to address the needs of those groups and populations that are at risk of the consequences of vitamin D deficiency.”
That said, the D-Health study is important in helping to distinguish when supplementation may – and may not – be of benefit, she noted.
“This and other research in the past 15 years have contributed to our understanding [of] what the ranges of vitamin D status are [in which] health consequences may be anticipated.”
The D-Health Trial was funded by the National Health and Medical Research Council. Dr. Neale and Dr. Schoenmakers have reported no relevant financial relationships.
version of this article first appeared on Medscape.com.
, including mortality linked to cardiovascular disease, new results from a large, placebo-controlled trial show.
“The take-home message is that routine vitamin D supplementation, irrespective of the dosing regimen, is unlikely to be beneficial in a population with a low prevalence of vitamin D deficiency,” first author Rachel E. Neale, PhD, of the Population Health Department, QIMR Berghofer Medical Research Institute, in Brisbane, Australia, told this news organization.
Despite extensive previous research on vitamin D supplementation, “mortality has not been the primary outcome in any previous large trial of high-dose vitamin D supplementation,” Dr. Neale and coauthors noted. The results, published online in Lancet Diabetes & Endocrinology, are from the D-Health trial.
With more than 20,000 participants, this is the largest intermittent-dosing trial to date, the authors noted. The primary outcome was all-cause mortality.
In an accompanying editorial, Inez Schoenmakers, PhD, noted that “the findings [are] highly relevant for population policy, owing to the study’s population-based design, large scale, and long duration.”
This new “research contributes to the concept that improving vitamin D status with supplementation in a mostly vitamin D-replete older population does not influence all-cause mortality,” Dr. Schoenmakers, of the Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, England, said in an interview.
“This is not dissimilar to research with many other nutrients showing that increasing intake above the adequate intake has no further health benefits,” she added.
D-Health Trial
The D-Health Trial involved 21,315 participants in Australia, enrolled between February 2014 and June 2015, who had not been screened for vitamin D deficiency but were largely considered to be vitamin D replete. They were a mean age of 69.3 years and 54% were men.
Participants were randomized 1:1 to a once-monthly oral vitamin D3 supplementation of 60,000 IU (n = 10,662) or a placebo capsule (n = 10,653).
They were permitted to take up to 2,000 IU/day of supplemental vitamin D in addition to the study protocol and had no history of kidney stones, hypercalcemia, hyperparathyroidism, osteomalacia, or sarcoidosis.
Over a median follow-up of 5.7 years, there were 1,100 deaths: 562 in the vitamin D group (5.3%) and 538 in the placebo group (5.1%). With a hazard ratio (HR) for all-cause mortality of 1.04, the difference was not significant (P = .47).
There were also no significant differences in terms of mortality from cardiovascular disease (HR, 0.96; P = .77), cancer (HR, 1.15; P = .13), or other causes (HR, 0.83; P = .15).
Rates of total adverse events between the two groups, including hypercalcemia and kidney stones, were similar.
An exploratory analysis excluding the first 2 years of follow-up in fact showed a numerically higher hazard ratio for cancer mortality in the vitamin D group versus no supplementation (HR, 1.24; P = .05). However, the authors noted that the effect was “not apparent when the analysis was restricted to deaths that were coded by the study team and not officially coded.”
Nevertheless, “our findings, from a large study in an unscreened population, give pause to earlier reports that vitamin D supplements might reduce cancer mortality,” they underscored.
Retention and adherence in the study were high, each exceeding 80%. Although blood samples were not collected at baseline, samples from 3,943 randomly sampled participants during follow-up showed mean serum 25-hydroxy-vitamin D concentrations of 77 nmol/L in the placebo group and 115 nmol/L in the vitamin D group, both within the normal range of 50-125 nmol/L.
Findings supported by previous research
The trial results are consistent with those of prior large studies and meta-analyses of older adults with a low prevalence of vitamin D deficiency showing that vitamin D3 supplementation, regardless of whether taken daily or monthly, is not likely to have an effect on all-cause mortality.
In the US VITAL trial, recently published in the New England Journal of Medicine, among 25,871 participants administered 2,000 IU/day of vitamin D3 for a median of 5.3 years, there was no reduction in all-cause mortality.
The ViDA trial of 5,110 older adults in New Zealand, published in 2019 in the Journal of Endocrinological Investigation, also showed monthly vitamin D3 supplementation of 100,000 IU for a median of 3.3 years was not associated with a benefit in people who were not deficient.
“In total, the results from the large trials and meta-analyses suggest that routine supplementation of older adults in populations with a low prevalence of vitamin D deficiency is unlikely to reduce the rate of all-cause mortality,” Dr. Neale and colleagues concluded.
Longer-term supplementation beneficial?
The population was limited to older adults and the study had a relatively short follow-up period, which Dr. Neale noted was necessary for pragmatic reasons.
“Our primary outcome was all-cause mortality, so to have sufficient deaths we either needed to study older adults or a much larger sample of younger adults,” she explained.
“However, we felt that [the former] ... had biological justification, as there is evidence that vitamin D plays a role later in the course of a number of diseases, with potential impacts on mortality.”
She noted that recent studies evaluating genetically predicted concentrations of serum 25(OH)D have further shown no link between those levels and all-cause mortality, stroke, or coronary heart disease.
“This confirms the statement that vitamin D is unlikely to be beneficial in people who are not vitamin D deficient, irrespective of whether supplementation occurs over the short or longer term,” Dr. Neale said.
The source of vitamin D, itself, is another consideration, with ongoing speculation of differences in benefits between dietary or supplementation sources versus sunlight exposure.
“Exposure to ultraviolet radiation, for which serum 25(OH)D concentration is a good marker, might confer benefits not mediated by vitamin D,” Dr. Neale and coauthors noted.
They added that the results in the older Australian population “cannot be generalized to populations with a higher prevalence of vitamin D deficiency, or with a greater proportion of people not of White ancestry, than the study population.”
Ten-year mortality rates from the D-Health trial are expected to be reported in the future.
Strategies still needed to address vitamin D deficiency
Further commenting on the findings, Dr. Schoenmakers underscored that “vitamin D deficiency is very common worldwide, [and] more should be done to develop strategies to address the needs of those groups and populations that are at risk of the consequences of vitamin D deficiency.”
That said, the D-Health study is important in helping to distinguish when supplementation may – and may not – be of benefit, she noted.
“This and other research in the past 15 years have contributed to our understanding [of] what the ranges of vitamin D status are [in which] health consequences may be anticipated.”
The D-Health Trial was funded by the National Health and Medical Research Council. Dr. Neale and Dr. Schoenmakers have reported no relevant financial relationships.
version of this article first appeared on Medscape.com.
FROM THE LANCET DIABETES & ENDOCRINOLOGY
Clinical Edge Journal Scan Commentary: Multiple Sclerosis February 2022
In another study (Maniscalco GT et al) exploring vaccine efficacy in 149 PwMS, treatment with interferon (IFN)-beta 1A resulted in improved anti-spike IgG specific humoral response levels than was seen in healthy controls response (median, 1,916 vs 1,089; P = .029) whereas reduced anti-spike IgG levels were significantly lower in patients treated with Cladribine (P = .002), Fingolimod (P < .0001), or Ocrelizumab (P < .0001). Clinical decisions regarding DMT treatment choice and DMT change focused solely on relapse rate and MRI are now insufficient without considering and incorporating vaccine response into the decision-making process. Further information across all DMT’s is needed to allow improved decision making regarding DMT choice. Confounding this problem is the frequency of unrecognized cognitive impairment (CI) in PwMS and the impact CI has on the shared decision-making process beyond EDSS.
In another study (Cavaco S et al) regarding CI in 408 PwMS, the presence of cognitive dysfunction was not only predictive of a higher risk for conversion from relapsing-remitting disease to progressive disease (adjusted odds ratio, 2.29; P = .043) and shorter survival (e.g. higher risk for death), (adjusted hazard ratio, 3.07; P = .006). The impact of such CI and progressive CI on vaccine hesitancy is unknown. Monitoring disease impact and change in cognitive function in PwMS remains another great unmet need in routine care of PwMS and evaluating the impact of CI on vaccine hesitancy and the shared decision-making process also requires further exploration and incorporation into routine care. Care of PwMS and the choice of DMT should hinge not only considerations about efficacy and safety but now must also incorporate patient vaccine hesitancy and response to vaccination.
In another study (Maniscalco GT et al) exploring vaccine efficacy in 149 PwMS, treatment with interferon (IFN)-beta 1A resulted in improved anti-spike IgG specific humoral response levels than was seen in healthy controls response (median, 1,916 vs 1,089; P = .029) whereas reduced anti-spike IgG levels were significantly lower in patients treated with Cladribine (P = .002), Fingolimod (P < .0001), or Ocrelizumab (P < .0001). Clinical decisions regarding DMT treatment choice and DMT change focused solely on relapse rate and MRI are now insufficient without considering and incorporating vaccine response into the decision-making process. Further information across all DMT’s is needed to allow improved decision making regarding DMT choice. Confounding this problem is the frequency of unrecognized cognitive impairment (CI) in PwMS and the impact CI has on the shared decision-making process beyond EDSS.
In another study (Cavaco S et al) regarding CI in 408 PwMS, the presence of cognitive dysfunction was not only predictive of a higher risk for conversion from relapsing-remitting disease to progressive disease (adjusted odds ratio, 2.29; P = .043) and shorter survival (e.g. higher risk for death), (adjusted hazard ratio, 3.07; P = .006). The impact of such CI and progressive CI on vaccine hesitancy is unknown. Monitoring disease impact and change in cognitive function in PwMS remains another great unmet need in routine care of PwMS and evaluating the impact of CI on vaccine hesitancy and the shared decision-making process also requires further exploration and incorporation into routine care. Care of PwMS and the choice of DMT should hinge not only considerations about efficacy and safety but now must also incorporate patient vaccine hesitancy and response to vaccination.
In another study (Maniscalco GT et al) exploring vaccine efficacy in 149 PwMS, treatment with interferon (IFN)-beta 1A resulted in improved anti-spike IgG specific humoral response levels than was seen in healthy controls response (median, 1,916 vs 1,089; P = .029) whereas reduced anti-spike IgG levels were significantly lower in patients treated with Cladribine (P = .002), Fingolimod (P < .0001), or Ocrelizumab (P < .0001). Clinical decisions regarding DMT treatment choice and DMT change focused solely on relapse rate and MRI are now insufficient without considering and incorporating vaccine response into the decision-making process. Further information across all DMT’s is needed to allow improved decision making regarding DMT choice. Confounding this problem is the frequency of unrecognized cognitive impairment (CI) in PwMS and the impact CI has on the shared decision-making process beyond EDSS.
In another study (Cavaco S et al) regarding CI in 408 PwMS, the presence of cognitive dysfunction was not only predictive of a higher risk for conversion from relapsing-remitting disease to progressive disease (adjusted odds ratio, 2.29; P = .043) and shorter survival (e.g. higher risk for death), (adjusted hazard ratio, 3.07; P = .006). The impact of such CI and progressive CI on vaccine hesitancy is unknown. Monitoring disease impact and change in cognitive function in PwMS remains another great unmet need in routine care of PwMS and evaluating the impact of CI on vaccine hesitancy and the shared decision-making process also requires further exploration and incorporation into routine care. Care of PwMS and the choice of DMT should hinge not only considerations about efficacy and safety but now must also incorporate patient vaccine hesitancy and response to vaccination.
Omicron subvariant 1.5 times more contagious than Omicron
according to CNBC.
The Statens Serum Institut, which monitors infectious diseases in Denmark, said that BA.2 is more contagious, but it doesn’t appear to increase hospitalizations or reduce how well the vaccine works.
BA.2 overtook BA.1 as the primary variant in Denmark within a few weeks, Troels Lillebaek, director of the institute, told CNBC. The subvariant has five unique mutations on a key part of the spike protein, which is what the coronavirus uses to invade human cells. This often means a higher rate of spreading.
The Omicron subvariant has been detected in at least 29 states in the United States and 56 countries, according to the latest update from Outbreak.info. The United States has detected 188 infections, with the worldwide total nearing 25,000.
Denmark has reported the highest number of cases, followed by the United Kingdom and India. Both Denmark and India have reported that BA.2 now accounts for about half of new COVID-19 cases in those countries.
On Jan. 28, the U.K. Health Security Agency said BA.2 has a “substantial” growth advantage over the original Omicron strain. The subvariant has spread faster in all regions of England where there were enough cases to conduct an analysis, the agency said in a report.
A preliminary evaluation found that BA.2 doesn’t appear to change how well the vaccine works compared to the original Omicron strain, the agency said. A booster dose was 70% effective at preventing symptomatic illness for BA.2, compared with 63% for the original Omicron strain.
The Centers for Disease Control and Prevention also said on Jan. 28 that, although the subvariant has become more common in some countries, it is currently at a low level in the United States and doesn’t appear to be more serious.
“Currently there is no evidence that the BA.2 lineage is more severe than the BA.1 lineage,” Kristen Nordlund, a CDC spokesperson, told CNBC.
The World Health Organization hasn’t labeled BA.2 a “variant of concern” so far but will continue to monitor it. WHO officials have said that new variants will arise as Omicron spreads across the world.
“The next variant of concern will be more fit, and what we mean by that is it will be more transmissible because it will have to overtake what is currently circulating,” Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said during a livestream on Jan. 25.
“The big question is whether or not future variants will be more or less severe,” she said.
A version of this article first appeared on WebMD.com.
according to CNBC.
The Statens Serum Institut, which monitors infectious diseases in Denmark, said that BA.2 is more contagious, but it doesn’t appear to increase hospitalizations or reduce how well the vaccine works.
BA.2 overtook BA.1 as the primary variant in Denmark within a few weeks, Troels Lillebaek, director of the institute, told CNBC. The subvariant has five unique mutations on a key part of the spike protein, which is what the coronavirus uses to invade human cells. This often means a higher rate of spreading.
The Omicron subvariant has been detected in at least 29 states in the United States and 56 countries, according to the latest update from Outbreak.info. The United States has detected 188 infections, with the worldwide total nearing 25,000.
Denmark has reported the highest number of cases, followed by the United Kingdom and India. Both Denmark and India have reported that BA.2 now accounts for about half of new COVID-19 cases in those countries.
On Jan. 28, the U.K. Health Security Agency said BA.2 has a “substantial” growth advantage over the original Omicron strain. The subvariant has spread faster in all regions of England where there were enough cases to conduct an analysis, the agency said in a report.
A preliminary evaluation found that BA.2 doesn’t appear to change how well the vaccine works compared to the original Omicron strain, the agency said. A booster dose was 70% effective at preventing symptomatic illness for BA.2, compared with 63% for the original Omicron strain.
The Centers for Disease Control and Prevention also said on Jan. 28 that, although the subvariant has become more common in some countries, it is currently at a low level in the United States and doesn’t appear to be more serious.
“Currently there is no evidence that the BA.2 lineage is more severe than the BA.1 lineage,” Kristen Nordlund, a CDC spokesperson, told CNBC.
The World Health Organization hasn’t labeled BA.2 a “variant of concern” so far but will continue to monitor it. WHO officials have said that new variants will arise as Omicron spreads across the world.
“The next variant of concern will be more fit, and what we mean by that is it will be more transmissible because it will have to overtake what is currently circulating,” Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said during a livestream on Jan. 25.
“The big question is whether or not future variants will be more or less severe,” she said.
A version of this article first appeared on WebMD.com.
according to CNBC.
The Statens Serum Institut, which monitors infectious diseases in Denmark, said that BA.2 is more contagious, but it doesn’t appear to increase hospitalizations or reduce how well the vaccine works.
BA.2 overtook BA.1 as the primary variant in Denmark within a few weeks, Troels Lillebaek, director of the institute, told CNBC. The subvariant has five unique mutations on a key part of the spike protein, which is what the coronavirus uses to invade human cells. This often means a higher rate of spreading.
The Omicron subvariant has been detected in at least 29 states in the United States and 56 countries, according to the latest update from Outbreak.info. The United States has detected 188 infections, with the worldwide total nearing 25,000.
Denmark has reported the highest number of cases, followed by the United Kingdom and India. Both Denmark and India have reported that BA.2 now accounts for about half of new COVID-19 cases in those countries.
On Jan. 28, the U.K. Health Security Agency said BA.2 has a “substantial” growth advantage over the original Omicron strain. The subvariant has spread faster in all regions of England where there were enough cases to conduct an analysis, the agency said in a report.
A preliminary evaluation found that BA.2 doesn’t appear to change how well the vaccine works compared to the original Omicron strain, the agency said. A booster dose was 70% effective at preventing symptomatic illness for BA.2, compared with 63% for the original Omicron strain.
The Centers for Disease Control and Prevention also said on Jan. 28 that, although the subvariant has become more common in some countries, it is currently at a low level in the United States and doesn’t appear to be more serious.
“Currently there is no evidence that the BA.2 lineage is more severe than the BA.1 lineage,” Kristen Nordlund, a CDC spokesperson, told CNBC.
The World Health Organization hasn’t labeled BA.2 a “variant of concern” so far but will continue to monitor it. WHO officials have said that new variants will arise as Omicron spreads across the world.
“The next variant of concern will be more fit, and what we mean by that is it will be more transmissible because it will have to overtake what is currently circulating,” Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said during a livestream on Jan. 25.
“The big question is whether or not future variants will be more or less severe,” she said.
A version of this article first appeared on WebMD.com.
Surrogate endpoints acceptable in AML trials, says FDA
The Food and Drug Administration has been harshly criticized for using surrogate endpoints in clinical trials in its approval of new drugs, and especially so in oncology, where critics have argued that the only truly meaningful endpoint is overall survival (OS).
But the FDA is now fighting back and is arguing that in certain cases surrogate endpoints do translate to overall survival benefits. A case in point is in clinical trials of new treatments being investigated in patients newly diagnosed with acute myeloid leukemia (AML).
The results show that these particular surrogate endpoints do have real value in predicting the efficacy of drugs for the treatment of newly diagnosed AML, they concluded.
“To our knowledge, our results represent the first direct examination of the relationship of response rate and EFS to OS using trial-level and patient-level data in patients with newly diagnosed AML treated with intensive induction chemotherapy,” the FDA investigators commented.
“The results support the FDA’s acceptance of EFS as a clinical benefit endpoint supportive of traditional approval for treatments with curative intent,” they added.
The analysis was published online on Dec. 10, 2021, in the Journal of Clinical Oncology.
“The central finding of the article, that both EFS and the CR rate are reliably associated with improved OS, is of immediate relevance and indicates that these parameters represent acceptable and appropriate surrogate endpoints for clinical trials of AML,” Courtney DiNardo, MD, University of Texas MD Anderson Cancer Center, Houston, and Daniel Pollyea, MD, University of Colorado at Denver, Aurora, wrote in an accompanying editorial.
“The establishment of CR and EFS as appropriate surrogate endpoints for patients with newly diagnosed AML receiving intensive chemotherapy will allow earlier evaluation of novel therapies and speed the delivery of safe and effective therapies to our patients,” they added.
Analysis of clinical trials submitted for approval
The FDA investigators conducted an analysis of eight trials that had been submitted to the agency for licensing approval between 2007 and 2011. Together, the trials included a total of 4,482 patients with newly diagnosed AML.
Five trials evaluated gemtuzumab ozogamicin (Mylotarg), while two trials evaluated a daunorubicin and cytarabine liposome injection, also known as CPX-351 (Vyxeos), and one trial evaluated midostaurin (RYDAPT).
“All were approved in combination with, or for use as, intensive induction chemotherapy in patients with newly diagnosed AML,” the team wrote. Both trial-level and patient-level associations between responses, EFS, and OS were evaluated.
The association between the hazard ratio for OS and the odds ratio for CR at the trial level was “moderate.” The association between the HR for OS and the OR for lesser response rates – namely, CR with incomplete hematologic recovery (CRi) and CR with incomplete platelet recovery (CRp) – was similarly moderate, as investigators note.
On the other hand, while the associations between the HR for OS and the HR for EFS were again moderate, “on the basis of the harmonized primary definition of EFS across trials, the association became stronger,” the authors reported. The harmonized definition of EFS across the trials included time from random assignment to treatment failure, relapse from CR, or death from any cause, whichever occurred earlier.
The FDA authors cautioned that a significant number of patients who relapsed did not die during the course of the clinical trial, resulting in a considerably longer OS, compared with EFS in some patients. However, to further explore the relationship between response and survival, a patient-level analysis of response – namely, CR versus CRi or CRp versus no response – was performed.”Patients who achieved a CR had a [27%] better OS, compared with patients whose best response was CRi or CRp,” the authors noted.
Patients who achieved a CRi or a CRp as their best response still had a 54% better OS, compared with patients who achieved no response, irrespective of the treatment received, they added.
Interestingly enough, a small number of patients who had no response to treatment also experienced prolonged survival, possibly because of successful second-line therapy, the authors speculated.
Effective salvage therapies
Commenting further in their editorial, Dr. DiNardo and Dr. Pollyea wrote that, given that there are now multiple effective salvage therapies for the treatment of AML, an OS endpoint no longer solely reflects the effectiveness of an initial therapy, as survival will also be affected by subsequent lines of AML-directed treatment.
“Accordingly, OS should no longer be considered the sole determinant of the value of a new therapy,” the editorialists emphasized.
Furthermore, as the treatment of AML is increasingly based on biologically defined and differentially targeted subsets, “the required sample sizes and timelines to run a proper randomized, phase 3 study for an OS end point of a rare AML subset become logistically untenable,” they wrote.
That said, the editorialists felt the fact that FDA employees performed this meta-analysis at all was “highly laudable.” “It is, moreover, gratifying to know that the experiences of clinical trial participants can be maximized beyond the original contributions made to the studies in which they originally volunteered,” the editorialists observed.
“In the United States, this example should inspire investigators and industry partners to prioritize similar analyses with their [own] data sets,” they added.
Dr. Norsworthy, Dr. DiNardo, and Dr. Pollyea disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has been harshly criticized for using surrogate endpoints in clinical trials in its approval of new drugs, and especially so in oncology, where critics have argued that the only truly meaningful endpoint is overall survival (OS).
But the FDA is now fighting back and is arguing that in certain cases surrogate endpoints do translate to overall survival benefits. A case in point is in clinical trials of new treatments being investigated in patients newly diagnosed with acute myeloid leukemia (AML).
The results show that these particular surrogate endpoints do have real value in predicting the efficacy of drugs for the treatment of newly diagnosed AML, they concluded.
“To our knowledge, our results represent the first direct examination of the relationship of response rate and EFS to OS using trial-level and patient-level data in patients with newly diagnosed AML treated with intensive induction chemotherapy,” the FDA investigators commented.
“The results support the FDA’s acceptance of EFS as a clinical benefit endpoint supportive of traditional approval for treatments with curative intent,” they added.
The analysis was published online on Dec. 10, 2021, in the Journal of Clinical Oncology.
“The central finding of the article, that both EFS and the CR rate are reliably associated with improved OS, is of immediate relevance and indicates that these parameters represent acceptable and appropriate surrogate endpoints for clinical trials of AML,” Courtney DiNardo, MD, University of Texas MD Anderson Cancer Center, Houston, and Daniel Pollyea, MD, University of Colorado at Denver, Aurora, wrote in an accompanying editorial.
“The establishment of CR and EFS as appropriate surrogate endpoints for patients with newly diagnosed AML receiving intensive chemotherapy will allow earlier evaluation of novel therapies and speed the delivery of safe and effective therapies to our patients,” they added.
Analysis of clinical trials submitted for approval
The FDA investigators conducted an analysis of eight trials that had been submitted to the agency for licensing approval between 2007 and 2011. Together, the trials included a total of 4,482 patients with newly diagnosed AML.
Five trials evaluated gemtuzumab ozogamicin (Mylotarg), while two trials evaluated a daunorubicin and cytarabine liposome injection, also known as CPX-351 (Vyxeos), and one trial evaluated midostaurin (RYDAPT).
“All were approved in combination with, or for use as, intensive induction chemotherapy in patients with newly diagnosed AML,” the team wrote. Both trial-level and patient-level associations between responses, EFS, and OS were evaluated.
The association between the hazard ratio for OS and the odds ratio for CR at the trial level was “moderate.” The association between the HR for OS and the OR for lesser response rates – namely, CR with incomplete hematologic recovery (CRi) and CR with incomplete platelet recovery (CRp) – was similarly moderate, as investigators note.
On the other hand, while the associations between the HR for OS and the HR for EFS were again moderate, “on the basis of the harmonized primary definition of EFS across trials, the association became stronger,” the authors reported. The harmonized definition of EFS across the trials included time from random assignment to treatment failure, relapse from CR, or death from any cause, whichever occurred earlier.
The FDA authors cautioned that a significant number of patients who relapsed did not die during the course of the clinical trial, resulting in a considerably longer OS, compared with EFS in some patients. However, to further explore the relationship between response and survival, a patient-level analysis of response – namely, CR versus CRi or CRp versus no response – was performed.”Patients who achieved a CR had a [27%] better OS, compared with patients whose best response was CRi or CRp,” the authors noted.
Patients who achieved a CRi or a CRp as their best response still had a 54% better OS, compared with patients who achieved no response, irrespective of the treatment received, they added.
Interestingly enough, a small number of patients who had no response to treatment also experienced prolonged survival, possibly because of successful second-line therapy, the authors speculated.
Effective salvage therapies
Commenting further in their editorial, Dr. DiNardo and Dr. Pollyea wrote that, given that there are now multiple effective salvage therapies for the treatment of AML, an OS endpoint no longer solely reflects the effectiveness of an initial therapy, as survival will also be affected by subsequent lines of AML-directed treatment.
“Accordingly, OS should no longer be considered the sole determinant of the value of a new therapy,” the editorialists emphasized.
Furthermore, as the treatment of AML is increasingly based on biologically defined and differentially targeted subsets, “the required sample sizes and timelines to run a proper randomized, phase 3 study for an OS end point of a rare AML subset become logistically untenable,” they wrote.
That said, the editorialists felt the fact that FDA employees performed this meta-analysis at all was “highly laudable.” “It is, moreover, gratifying to know that the experiences of clinical trial participants can be maximized beyond the original contributions made to the studies in which they originally volunteered,” the editorialists observed.
“In the United States, this example should inspire investigators and industry partners to prioritize similar analyses with their [own] data sets,” they added.
Dr. Norsworthy, Dr. DiNardo, and Dr. Pollyea disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has been harshly criticized for using surrogate endpoints in clinical trials in its approval of new drugs, and especially so in oncology, where critics have argued that the only truly meaningful endpoint is overall survival (OS).
But the FDA is now fighting back and is arguing that in certain cases surrogate endpoints do translate to overall survival benefits. A case in point is in clinical trials of new treatments being investigated in patients newly diagnosed with acute myeloid leukemia (AML).
The results show that these particular surrogate endpoints do have real value in predicting the efficacy of drugs for the treatment of newly diagnosed AML, they concluded.
“To our knowledge, our results represent the first direct examination of the relationship of response rate and EFS to OS using trial-level and patient-level data in patients with newly diagnosed AML treated with intensive induction chemotherapy,” the FDA investigators commented.
“The results support the FDA’s acceptance of EFS as a clinical benefit endpoint supportive of traditional approval for treatments with curative intent,” they added.
The analysis was published online on Dec. 10, 2021, in the Journal of Clinical Oncology.
“The central finding of the article, that both EFS and the CR rate are reliably associated with improved OS, is of immediate relevance and indicates that these parameters represent acceptable and appropriate surrogate endpoints for clinical trials of AML,” Courtney DiNardo, MD, University of Texas MD Anderson Cancer Center, Houston, and Daniel Pollyea, MD, University of Colorado at Denver, Aurora, wrote in an accompanying editorial.
“The establishment of CR and EFS as appropriate surrogate endpoints for patients with newly diagnosed AML receiving intensive chemotherapy will allow earlier evaluation of novel therapies and speed the delivery of safe and effective therapies to our patients,” they added.
Analysis of clinical trials submitted for approval
The FDA investigators conducted an analysis of eight trials that had been submitted to the agency for licensing approval between 2007 and 2011. Together, the trials included a total of 4,482 patients with newly diagnosed AML.
Five trials evaluated gemtuzumab ozogamicin (Mylotarg), while two trials evaluated a daunorubicin and cytarabine liposome injection, also known as CPX-351 (Vyxeos), and one trial evaluated midostaurin (RYDAPT).
“All were approved in combination with, or for use as, intensive induction chemotherapy in patients with newly diagnosed AML,” the team wrote. Both trial-level and patient-level associations between responses, EFS, and OS were evaluated.
The association between the hazard ratio for OS and the odds ratio for CR at the trial level was “moderate.” The association between the HR for OS and the OR for lesser response rates – namely, CR with incomplete hematologic recovery (CRi) and CR with incomplete platelet recovery (CRp) – was similarly moderate, as investigators note.
On the other hand, while the associations between the HR for OS and the HR for EFS were again moderate, “on the basis of the harmonized primary definition of EFS across trials, the association became stronger,” the authors reported. The harmonized definition of EFS across the trials included time from random assignment to treatment failure, relapse from CR, or death from any cause, whichever occurred earlier.
The FDA authors cautioned that a significant number of patients who relapsed did not die during the course of the clinical trial, resulting in a considerably longer OS, compared with EFS in some patients. However, to further explore the relationship between response and survival, a patient-level analysis of response – namely, CR versus CRi or CRp versus no response – was performed.”Patients who achieved a CR had a [27%] better OS, compared with patients whose best response was CRi or CRp,” the authors noted.
Patients who achieved a CRi or a CRp as their best response still had a 54% better OS, compared with patients who achieved no response, irrespective of the treatment received, they added.
Interestingly enough, a small number of patients who had no response to treatment also experienced prolonged survival, possibly because of successful second-line therapy, the authors speculated.
Effective salvage therapies
Commenting further in their editorial, Dr. DiNardo and Dr. Pollyea wrote that, given that there are now multiple effective salvage therapies for the treatment of AML, an OS endpoint no longer solely reflects the effectiveness of an initial therapy, as survival will also be affected by subsequent lines of AML-directed treatment.
“Accordingly, OS should no longer be considered the sole determinant of the value of a new therapy,” the editorialists emphasized.
Furthermore, as the treatment of AML is increasingly based on biologically defined and differentially targeted subsets, “the required sample sizes and timelines to run a proper randomized, phase 3 study for an OS end point of a rare AML subset become logistically untenable,” they wrote.
That said, the editorialists felt the fact that FDA employees performed this meta-analysis at all was “highly laudable.” “It is, moreover, gratifying to know that the experiences of clinical trial participants can be maximized beyond the original contributions made to the studies in which they originally volunteered,” the editorialists observed.
“In the United States, this example should inspire investigators and industry partners to prioritize similar analyses with their [own] data sets,” they added.
Dr. Norsworthy, Dr. DiNardo, and Dr. Pollyea disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
A dermatologist-led model for CVD prevention in psoriasis may be feasible
A – may be feasible, given the positive perspectives expressed by both clinicians and patients in a set of electronic surveys, researchers say.
In an analysis of survey responses from 183 dermatologists and 322 patients, John S. Barbieri, MD, MBA, and coinvestigators found that more than two-thirds of dermatologists (69.3%) agreed it “seems doable” to check lipids and calculate a 10-year cardiovascular risk score, and over one-third (36.1%) agreed they could prescribe statins when indicated.
The patient survey was distributed through the National Psoriasis Foundation to individuals who were seeing a dermatologist or rheumatologist for psoriatic disease; the clinician survey was distributed through the American Academy of Dermatology to dermatologists who reported caring for patients with psoriasis. (A survey of rheumatologists was similarly conducted, but the number of participants fell short of the needed sample size.)
Most patients surveyed indicated they would be receptive to their dermatologist (or rheumatologist) playing a larger role in screening and managing CVD risk, and that they would be similarly likely to follow recommendations regarding risk screening and management whether the advice came their dermatologist/rheumatologist or from their PCP.
The clinician survey focused on lipids and statin use, and did not address other elements of risk management. Still, the researchers see their findings as an early but promising step in finding better models to improve cardiovascular outcomes for patients with psoriatic disease, who too often do not engage with their PCPs despite their increased risk of CVD and a higher risk of premature mortality from CVD.
Fewer than half of commercially insured adults aged under 65 years visit a PCP each year, the researchers noted. And among the patients in their survey, approximately 20% did not have a PCP or had not seen their PCP in the past year.
Other research has shown that only a small minority of patients with psoriasis have an encounter with their PCP within a year of establishing care with their dermatologist, and that “over half of patients with psoriasis have undetected risk factors like dyslipidemia or hypertension,” Dr. Barbieri, of the department of dermatology at Brigham and Women’s Hospital, Boston, said in an interview.
“There’s a gap here, a missing link in the chain of cardiovascular disease prevention,” he said. “What if the dermatologist or rheumatologist could be more engaged in [CV] risk protection? ... It’s the idea of meeting the patients where they are.”
The surveys
The clinician survey focused on statins because of their ease of use, efficacy and safety, and the need for minimal monitoring, Dr. Barbieri said in the interview. “On the spectrum of things you can do for cardiovascular disease prevention, it’s one of the easiest ones.”
In an accompanying editorial, cardiologists Michael S. Garshick, MD, MS, and Jeffrey S. Berger, MD, MS, both of the department of medicine, New York University, wrote that, “despite the well-described association between psoriasis and CVD, only 35% of patients with psoriasis diagnosed with hyperlipidemia are adequately treated with statin therapy.”
“For many of these patients, their dermatologist or rheumatologist may be their only source of contact with the health care system,” they added.
Most studies targeting CVD risk in psoriasis have focused on targeting psoriatic inflammation, and few studies have explored strategies to improve modifiable CVD risk factor control with pharmacological therapy, they said.
In addition to the questions about receptiveness to identifying and potentially treating CVD risk with statins, the dermatologist survey included a best-worst scaling choice experiment to assess preferences for implementation approaches. Dermatologists were asked to rank their preferences for eight implementation strategies that have been shown in published studies to help increase statin prescribing rates.
The three highest-ranked strategies among dermatologists were clinical decision support, physician educational outreach, and patient education materials. The lowest-ranked strategies were comparisons with peers, a pay-for-performance option, and a mobile app/texting service to remind patients to undergo CVD risk screening.
Of the 183 dermatologists in the survey, 28.4% were from academic settings, 11.5% were from multispecialty groups, and 45.4% were from dermatology groups. (A low response rate of 5.2% for dermatologists raises some questions about the generalizability of the findings, Dr. Garshick and Dr. Berger noted in their editorial.)
Where to go from here?
Asked to comment on the results, Jashin J. Wu, MD, founder and CEO of the Dermatology Research and Education Foundation, Irvine, Calif., who was not involved with the study, said that a larger role in CVD risk management is “not likely to find traction with everyday dermatologists.”
“It’s already a big ask for community dermatologists to go through the approval process to get biologics for patients, so I don’t think many would be willing to add more to their plate by taking a bigger role in CVD management,” he said in an interview. He generally has not prescribed statins, “as I don’t feel that is in my scope of work.”
In the interview, Dr. Barbieri said that a parallel qualitative study, not yet published, has looked at the facilitators and barriers – including time constraints and concern about scope of practice – to statin prescribing and other elements of cardiovascular risk reduction.
All told, he said, a centralized care coordinator model may be the best approach to engage the dermatologist more in CVD prevention, including lipid management, but to also “offload some of the management responsibility.”
In this model, which is partially described by Dr. Barbieri and colleagues, the dermatologist (or rheumatologist) would educate the patient, measure blood pressure and check a lipid panel, and refer the patient to a coordinator who would, in turn, collect more information and calculate a 10-year CVD risk score.
Using a protocol-driven clinical decision support approach, the care coordinator would provide counseling about diet, exercise, and smoking cessation, and about whether statin therapy or blood pressure management is indicated.
“That coordinator would be in a good position to help the patient work with their PCP, if they have one, to find a PCP if they don’t, or to use telemedicine or work with their dermatologist or rheumatologist,” Dr. Barbieri said.
The centralized care coordinator service could be funded through grants, charitable funds, and patient assistance funds so that it is free to patients, he said, and could possibly be “housed in the National Psoriasis Foundation.”
Dr. Barbieri said he and his colleagues plan to design a clinical trial to test whether such a model can be adopted in practice and whether it can improve outcomes associated with CVD risk management.
In their editorial, Dr. Garshick and Dr. Berger, who is director of NYU Langone’s Center for the Prevention of Cardiovascular Disease, wrote that many patients with psoriatic disease have or are at risk for cardiometabolic conditions, and that CVD risk reduction should extend beyond lipid management to include blood pressure, glucose lowering, obesity management, and antiplatelet therapy.
The joint AAD-NPF guidelines for the management and treatment of psoriasis with awareness and attention to comorbidities, published in 2019, were among the first to formally recognize the enhanced CVD risk of patients with psoriasis, they noted.
The guidelines call upon dermatologists to inform patients of the psoriasis-CVD association and ensure their patients are engaged with their PCP or cardiologist for appropriate screening. Now, the editorialists say, “moving the needle forward includes refining and developing modifiable CVD risk reduction strategies for patients with psoriasis, and collaboration between the fields of dermatology, rheumatology, and cardiology is key.”
Incorporating a preventive cardiologist into combined dermatology-rheumatology clinics, or partnering as a freestanding cardioinflammatory clinic, also have potential to improve CVD risk, they wrote.
The survey study was supported by a grant from the NPF Psoriasis Prevention Initiative. Dr. Barbieri reported no conflicts of interest. Several authors disclosed consulting fees and grants from numerous pharmaceutical companies. Dr. Berger reported receiving personal fees from Janssen and grants from AstraZeneca outside of the submitted work. Dr. Garshick reported receiving personal fees from AbbVie outside of the submitted work.
A – may be feasible, given the positive perspectives expressed by both clinicians and patients in a set of electronic surveys, researchers say.
In an analysis of survey responses from 183 dermatologists and 322 patients, John S. Barbieri, MD, MBA, and coinvestigators found that more than two-thirds of dermatologists (69.3%) agreed it “seems doable” to check lipids and calculate a 10-year cardiovascular risk score, and over one-third (36.1%) agreed they could prescribe statins when indicated.
The patient survey was distributed through the National Psoriasis Foundation to individuals who were seeing a dermatologist or rheumatologist for psoriatic disease; the clinician survey was distributed through the American Academy of Dermatology to dermatologists who reported caring for patients with psoriasis. (A survey of rheumatologists was similarly conducted, but the number of participants fell short of the needed sample size.)
Most patients surveyed indicated they would be receptive to their dermatologist (or rheumatologist) playing a larger role in screening and managing CVD risk, and that they would be similarly likely to follow recommendations regarding risk screening and management whether the advice came their dermatologist/rheumatologist or from their PCP.
The clinician survey focused on lipids and statin use, and did not address other elements of risk management. Still, the researchers see their findings as an early but promising step in finding better models to improve cardiovascular outcomes for patients with psoriatic disease, who too often do not engage with their PCPs despite their increased risk of CVD and a higher risk of premature mortality from CVD.
Fewer than half of commercially insured adults aged under 65 years visit a PCP each year, the researchers noted. And among the patients in their survey, approximately 20% did not have a PCP or had not seen their PCP in the past year.
Other research has shown that only a small minority of patients with psoriasis have an encounter with their PCP within a year of establishing care with their dermatologist, and that “over half of patients with psoriasis have undetected risk factors like dyslipidemia or hypertension,” Dr. Barbieri, of the department of dermatology at Brigham and Women’s Hospital, Boston, said in an interview.
“There’s a gap here, a missing link in the chain of cardiovascular disease prevention,” he said. “What if the dermatologist or rheumatologist could be more engaged in [CV] risk protection? ... It’s the idea of meeting the patients where they are.”
The surveys
The clinician survey focused on statins because of their ease of use, efficacy and safety, and the need for minimal monitoring, Dr. Barbieri said in the interview. “On the spectrum of things you can do for cardiovascular disease prevention, it’s one of the easiest ones.”
In an accompanying editorial, cardiologists Michael S. Garshick, MD, MS, and Jeffrey S. Berger, MD, MS, both of the department of medicine, New York University, wrote that, “despite the well-described association between psoriasis and CVD, only 35% of patients with psoriasis diagnosed with hyperlipidemia are adequately treated with statin therapy.”
“For many of these patients, their dermatologist or rheumatologist may be their only source of contact with the health care system,” they added.
Most studies targeting CVD risk in psoriasis have focused on targeting psoriatic inflammation, and few studies have explored strategies to improve modifiable CVD risk factor control with pharmacological therapy, they said.
In addition to the questions about receptiveness to identifying and potentially treating CVD risk with statins, the dermatologist survey included a best-worst scaling choice experiment to assess preferences for implementation approaches. Dermatologists were asked to rank their preferences for eight implementation strategies that have been shown in published studies to help increase statin prescribing rates.
The three highest-ranked strategies among dermatologists were clinical decision support, physician educational outreach, and patient education materials. The lowest-ranked strategies were comparisons with peers, a pay-for-performance option, and a mobile app/texting service to remind patients to undergo CVD risk screening.
Of the 183 dermatologists in the survey, 28.4% were from academic settings, 11.5% were from multispecialty groups, and 45.4% were from dermatology groups. (A low response rate of 5.2% for dermatologists raises some questions about the generalizability of the findings, Dr. Garshick and Dr. Berger noted in their editorial.)
Where to go from here?
Asked to comment on the results, Jashin J. Wu, MD, founder and CEO of the Dermatology Research and Education Foundation, Irvine, Calif., who was not involved with the study, said that a larger role in CVD risk management is “not likely to find traction with everyday dermatologists.”
“It’s already a big ask for community dermatologists to go through the approval process to get biologics for patients, so I don’t think many would be willing to add more to their plate by taking a bigger role in CVD management,” he said in an interview. He generally has not prescribed statins, “as I don’t feel that is in my scope of work.”
In the interview, Dr. Barbieri said that a parallel qualitative study, not yet published, has looked at the facilitators and barriers – including time constraints and concern about scope of practice – to statin prescribing and other elements of cardiovascular risk reduction.
All told, he said, a centralized care coordinator model may be the best approach to engage the dermatologist more in CVD prevention, including lipid management, but to also “offload some of the management responsibility.”
In this model, which is partially described by Dr. Barbieri and colleagues, the dermatologist (or rheumatologist) would educate the patient, measure blood pressure and check a lipid panel, and refer the patient to a coordinator who would, in turn, collect more information and calculate a 10-year CVD risk score.
Using a protocol-driven clinical decision support approach, the care coordinator would provide counseling about diet, exercise, and smoking cessation, and about whether statin therapy or blood pressure management is indicated.
“That coordinator would be in a good position to help the patient work with their PCP, if they have one, to find a PCP if they don’t, or to use telemedicine or work with their dermatologist or rheumatologist,” Dr. Barbieri said.
The centralized care coordinator service could be funded through grants, charitable funds, and patient assistance funds so that it is free to patients, he said, and could possibly be “housed in the National Psoriasis Foundation.”
Dr. Barbieri said he and his colleagues plan to design a clinical trial to test whether such a model can be adopted in practice and whether it can improve outcomes associated with CVD risk management.
In their editorial, Dr. Garshick and Dr. Berger, who is director of NYU Langone’s Center for the Prevention of Cardiovascular Disease, wrote that many patients with psoriatic disease have or are at risk for cardiometabolic conditions, and that CVD risk reduction should extend beyond lipid management to include blood pressure, glucose lowering, obesity management, and antiplatelet therapy.
The joint AAD-NPF guidelines for the management and treatment of psoriasis with awareness and attention to comorbidities, published in 2019, were among the first to formally recognize the enhanced CVD risk of patients with psoriasis, they noted.
The guidelines call upon dermatologists to inform patients of the psoriasis-CVD association and ensure their patients are engaged with their PCP or cardiologist for appropriate screening. Now, the editorialists say, “moving the needle forward includes refining and developing modifiable CVD risk reduction strategies for patients with psoriasis, and collaboration between the fields of dermatology, rheumatology, and cardiology is key.”
Incorporating a preventive cardiologist into combined dermatology-rheumatology clinics, or partnering as a freestanding cardioinflammatory clinic, also have potential to improve CVD risk, they wrote.
The survey study was supported by a grant from the NPF Psoriasis Prevention Initiative. Dr. Barbieri reported no conflicts of interest. Several authors disclosed consulting fees and grants from numerous pharmaceutical companies. Dr. Berger reported receiving personal fees from Janssen and grants from AstraZeneca outside of the submitted work. Dr. Garshick reported receiving personal fees from AbbVie outside of the submitted work.
A – may be feasible, given the positive perspectives expressed by both clinicians and patients in a set of electronic surveys, researchers say.
In an analysis of survey responses from 183 dermatologists and 322 patients, John S. Barbieri, MD, MBA, and coinvestigators found that more than two-thirds of dermatologists (69.3%) agreed it “seems doable” to check lipids and calculate a 10-year cardiovascular risk score, and over one-third (36.1%) agreed they could prescribe statins when indicated.
The patient survey was distributed through the National Psoriasis Foundation to individuals who were seeing a dermatologist or rheumatologist for psoriatic disease; the clinician survey was distributed through the American Academy of Dermatology to dermatologists who reported caring for patients with psoriasis. (A survey of rheumatologists was similarly conducted, but the number of participants fell short of the needed sample size.)
Most patients surveyed indicated they would be receptive to their dermatologist (or rheumatologist) playing a larger role in screening and managing CVD risk, and that they would be similarly likely to follow recommendations regarding risk screening and management whether the advice came their dermatologist/rheumatologist or from their PCP.
The clinician survey focused on lipids and statin use, and did not address other elements of risk management. Still, the researchers see their findings as an early but promising step in finding better models to improve cardiovascular outcomes for patients with psoriatic disease, who too often do not engage with their PCPs despite their increased risk of CVD and a higher risk of premature mortality from CVD.
Fewer than half of commercially insured adults aged under 65 years visit a PCP each year, the researchers noted. And among the patients in their survey, approximately 20% did not have a PCP or had not seen their PCP in the past year.
Other research has shown that only a small minority of patients with psoriasis have an encounter with their PCP within a year of establishing care with their dermatologist, and that “over half of patients with psoriasis have undetected risk factors like dyslipidemia or hypertension,” Dr. Barbieri, of the department of dermatology at Brigham and Women’s Hospital, Boston, said in an interview.
“There’s a gap here, a missing link in the chain of cardiovascular disease prevention,” he said. “What if the dermatologist or rheumatologist could be more engaged in [CV] risk protection? ... It’s the idea of meeting the patients where they are.”
The surveys
The clinician survey focused on statins because of their ease of use, efficacy and safety, and the need for minimal monitoring, Dr. Barbieri said in the interview. “On the spectrum of things you can do for cardiovascular disease prevention, it’s one of the easiest ones.”
In an accompanying editorial, cardiologists Michael S. Garshick, MD, MS, and Jeffrey S. Berger, MD, MS, both of the department of medicine, New York University, wrote that, “despite the well-described association between psoriasis and CVD, only 35% of patients with psoriasis diagnosed with hyperlipidemia are adequately treated with statin therapy.”
“For many of these patients, their dermatologist or rheumatologist may be their only source of contact with the health care system,” they added.
Most studies targeting CVD risk in psoriasis have focused on targeting psoriatic inflammation, and few studies have explored strategies to improve modifiable CVD risk factor control with pharmacological therapy, they said.
In addition to the questions about receptiveness to identifying and potentially treating CVD risk with statins, the dermatologist survey included a best-worst scaling choice experiment to assess preferences for implementation approaches. Dermatologists were asked to rank their preferences for eight implementation strategies that have been shown in published studies to help increase statin prescribing rates.
The three highest-ranked strategies among dermatologists were clinical decision support, physician educational outreach, and patient education materials. The lowest-ranked strategies were comparisons with peers, a pay-for-performance option, and a mobile app/texting service to remind patients to undergo CVD risk screening.
Of the 183 dermatologists in the survey, 28.4% were from academic settings, 11.5% were from multispecialty groups, and 45.4% were from dermatology groups. (A low response rate of 5.2% for dermatologists raises some questions about the generalizability of the findings, Dr. Garshick and Dr. Berger noted in their editorial.)
Where to go from here?
Asked to comment on the results, Jashin J. Wu, MD, founder and CEO of the Dermatology Research and Education Foundation, Irvine, Calif., who was not involved with the study, said that a larger role in CVD risk management is “not likely to find traction with everyday dermatologists.”
“It’s already a big ask for community dermatologists to go through the approval process to get biologics for patients, so I don’t think many would be willing to add more to their plate by taking a bigger role in CVD management,” he said in an interview. He generally has not prescribed statins, “as I don’t feel that is in my scope of work.”
In the interview, Dr. Barbieri said that a parallel qualitative study, not yet published, has looked at the facilitators and barriers – including time constraints and concern about scope of practice – to statin prescribing and other elements of cardiovascular risk reduction.
All told, he said, a centralized care coordinator model may be the best approach to engage the dermatologist more in CVD prevention, including lipid management, but to also “offload some of the management responsibility.”
In this model, which is partially described by Dr. Barbieri and colleagues, the dermatologist (or rheumatologist) would educate the patient, measure blood pressure and check a lipid panel, and refer the patient to a coordinator who would, in turn, collect more information and calculate a 10-year CVD risk score.
Using a protocol-driven clinical decision support approach, the care coordinator would provide counseling about diet, exercise, and smoking cessation, and about whether statin therapy or blood pressure management is indicated.
“That coordinator would be in a good position to help the patient work with their PCP, if they have one, to find a PCP if they don’t, or to use telemedicine or work with their dermatologist or rheumatologist,” Dr. Barbieri said.
The centralized care coordinator service could be funded through grants, charitable funds, and patient assistance funds so that it is free to patients, he said, and could possibly be “housed in the National Psoriasis Foundation.”
Dr. Barbieri said he and his colleagues plan to design a clinical trial to test whether such a model can be adopted in practice and whether it can improve outcomes associated with CVD risk management.
In their editorial, Dr. Garshick and Dr. Berger, who is director of NYU Langone’s Center for the Prevention of Cardiovascular Disease, wrote that many patients with psoriatic disease have or are at risk for cardiometabolic conditions, and that CVD risk reduction should extend beyond lipid management to include blood pressure, glucose lowering, obesity management, and antiplatelet therapy.
The joint AAD-NPF guidelines for the management and treatment of psoriasis with awareness and attention to comorbidities, published in 2019, were among the first to formally recognize the enhanced CVD risk of patients with psoriasis, they noted.
The guidelines call upon dermatologists to inform patients of the psoriasis-CVD association and ensure their patients are engaged with their PCP or cardiologist for appropriate screening. Now, the editorialists say, “moving the needle forward includes refining and developing modifiable CVD risk reduction strategies for patients with psoriasis, and collaboration between the fields of dermatology, rheumatology, and cardiology is key.”
Incorporating a preventive cardiologist into combined dermatology-rheumatology clinics, or partnering as a freestanding cardioinflammatory clinic, also have potential to improve CVD risk, they wrote.
The survey study was supported by a grant from the NPF Psoriasis Prevention Initiative. Dr. Barbieri reported no conflicts of interest. Several authors disclosed consulting fees and grants from numerous pharmaceutical companies. Dr. Berger reported receiving personal fees from Janssen and grants from AstraZeneca outside of the submitted work. Dr. Garshick reported receiving personal fees from AbbVie outside of the submitted work.
FROM JAMA DERMATOLOGY
Assessing imminent suicide risk: What about future planning?
A patient who has the ability to plan for their future can be reassuring for a clinician who is conducting an imminent suicide risk evaluation. However, that patient may report future plans even as they are contemplating suicide. Therefore, this variable should not be simplified categorically to the mere presence or absence of future plans. Such plans, and the process by which they are produced, should be examined more closely. In this article, we explore the relationship between a patient’s intent to die by suicide in the near future and their ability to maintain future planning. We also use case examples to highlight certain characteristics that may allow future planning to be integrated more reliably into the assessment of imminent risk of suicide.
An inherent challenge
Suicide risk assessment can be challenging due to the numerous factors that can contribute to a patient’s suicidal intent.1 Some individuals don’t seek help when they develop suicidal thoughts, and even among those who do, recognizing who may be at greater risk is not an easy task. Sometimes, this leads to inadequate interventions and a subsequent failure to ensure safety, or to an overreaction and unnecessary hospitalization.
A common difficulty is a patient’s unwillingness to cooperate with the examination.2 Some patients do not present voluntarily, while others may seek help but then conceal suicidal intent. In a sample of 66 psychotherapy patients who reported concealing suicidal ideation from their therapist and provided short essay responses explaining their motives for doing so, approximately 70% said fear of involuntary hospitalization was their motive to hide those thoughts from their doctor.3 Other reasons for concealment are shame, stigma, embarrassment, fear of rejection, and loss of autonomy.3-5 Moreover, higher levels of suicidal ideation are associated with treatment avoidance.6 Therefore, it is important to improve suicide predictability independent of the patient report. In a survey of 1,150 emergency physicians in Australasia, Canada, the United Kingdom, and the United States, the need for evidence-based guidelines on when to hospitalize a patient at risk for suicide was ranked as the 7th-highest priority.7 There are limitations to using suicide risk assessment scales,8,9 because scales designed to have high sensitivity are less specific, and those with high specificity fail to identify individuals at high risk.9,10 Most of the research conducted in this area has focused on the risk of suicide in 2 to 6 months, and not on imminent risk.11
What is ‘imminent’ risk?
There is no specific time definition for “imminent risk,” but the Lifeline Standards, Trainings, and Practices Subcommittee, a group of national and international experts in suicide prevention, defines imminent risk of suicide as the belief that there is a “close temporal connection between the person’s current risk status and actions that could lead to his/her suicide.”12 Practically, suicide could be considered imminent when it occurs within a few days of the evaluation. However, suicide may take place within a few days of an evaluation due to new life events or impulsive actions, which may explain why imminent risk of suicide can be difficult to define and predict. In clinical practice, there is little evidence-based knowledge about estimating imminent risk. Recent studies have explored certain aspects of a patient’s history in the attempt to improve imminent risk predictability.13 In light of the complexity of this matter and the lack of widely validated tools, clinicians are encouraged to share their experience with other clinicians while the efforts to advance evidence-based knowledge and tools continue.
The function of future planning
Future planning is a mental process embedded in several crucial executive functions. It operates on a daily basis to organize, prioritize, and carry out tasks to achieve day-to-day and more distant future goals. Some research has found that a decreased ability to generate positive future thoughts is linked to increased suicide risk in the long term.14-17 Positive future planning can be affected by even minor fluctuations in mood because the additional processing capacity needed during these mood changes may limit one’s ability to generate positive future thoughts.18 Patients experiencing mood episodes are known to experience cognitive dysfunctions.19-21 However, additional measurable cognitive changes have been detected in patients who are suicidal. For example, in a small study (N = 33) of patients with depression, those who were experiencing suicidal thoughts underperformed on several measures of executive functioning compared to patients with no suicidal ideation.22
However, when addressing imminent rather than future suicide risk, even neutral future plans—such as day-to-day plans or those addressing barriers to treatment—can be a meaningful indicator of the investment in one’s future beyond a potential near-term suicide, and therefore can be explored to further inform the risk evaluation. Significant mental resources can be consumed due to the level of distress associated with contemplating suicide, and therefore patients may have a reduced capacity for day-to-day planning. Thus, serious suicide contemplation is less likely in the presence of typical future planning.
Continue to: Characteristics of future planning...
Characteristics of future planning
Some patients may pretend to engage in future planning to indicate the absence of suicidal intent. This necessitates a more nuanced assessment of future plans beyond whether they exist or not by examining the genuineness of such plans, and the authenticity of the process by which they are produced. The Table lists 3 characteristics of future plans/future planning that, based on our clinical experience, can be helpful to evaluate during an imminent suicide risk evaluation. These are described in the following case examples.
Specificity and richness of details
CASE 1
Mr. A, a college student, presents to the emergency department (ED) complaining of depression and suicidal thoughts that he is able to dismiss. He would like to avoid starting a medication because he has finals in 2 weeks and is worried about adverse effects. He learned about cognitive-behavioral therapy and is interested in getting a referral to a specific office because it is located within a walking distance from campus and easy for him to access because he does not own a car.
The volume of details expressed in a patient’s future plans is important. The more detailed these plans are, the more likely the patient is invested in them. Attendance to the details, especially when addressing expected barriers to treatment, such as transportation, can be evidence of genuine future planning and subsequently of low imminent suicide risk. Spreng et al23 found that autobiographic plans that are more specific and richer in detail recruit additional brain regions that are not recruited in plans that are sparsely detailed or constructed from more generalized representations.
CASE 2
An ambulance transports Ms. B, age 42, from a primary care clinic to the ED because she has been having suicidal thoughts, with a plan to hang herself, for the past 2 days. During the evaluation, Ms. B denies having further suicidal thoughts and declines inpatient admission. She claims that she cannot be away from her children because she is their primary caretaker. Collateral information reveals that Ms. B’s mother has been caring for her children for the last 2 weeks because Ms. B has been too depressed to do so. She continues to refuse admission and is in tears while trying to explain how her absence due to inpatient treatment will be detrimental to her children. Eventually, she angrily accuses the clinician of abusing her children by forcing her to be hospitalized.
In an effort to conceal suicidal intent, patients may present obligations or excuses that would be an obstacle to psychiatric hospitalization. This might give a false perception of intact future planning. However, in these cases, patients often fail to volunteer details about their future plans or show evidence for actual attendance to their obligations. Due to the lack of tangible details to explain the negative effects of inpatient treatment, patients may compensate by using an exaggerated emotional response, with a strong emotional attachment to the obligation and severe distress over their potential inability to fulfill it due to a psychiatric hospitalization. This may contribute to concealing suicidal intent in a different way. A patient may be distressed by the prospect of losing their autonomy or ability to attempt suicide if hospitalized, and they may employ a false excuse as a substitute for the actual reason underlying their distress. A clinician may be falsely reassured if they do not accurately perceive the true cause of the emotional distress. Upon deeper exploration, the expressed emotional attachment is often found to be superficial and has little substantive support.
Continue to: Dedication to addressing acheivable goals in the near future...
Dedication to addressing achievable goals in the near future
CASE 3
Ms. C, age 15, survived a suicide attempt via a medication overdose. She says that she regrets what she did and is not planning to attempt suicide again. Ms. C says she no longer wants to die because in the future she wants to help people by becoming a nurse. She adds that there is a lot waiting for her because she wants to travel all over the world.
Ms. D, age 15, also survived a suicide attempt via a medication overdose. She also says that she regrets what she did and is not planning to attempt suicide again. Ms. D asks whether the physician would be willing to contact the school on her behalf to explain why she had to miss class and to ask for accommodations at school to assist with her panic attacks.
Future planning that involves a patient generating new plans to address current circumstances or the near future may be more reliable than future planning in which a patient repeats their previously constructed plans for the distant future. Eliciting more distant plans, such as a career or family-oriented decisions, indicates the ability to access these “memorized” plans rather than the ability to generate future plans.
Plans that address the distant future, such as those expressed by Ms. C, may have stronger neurologic imprints as a result of repeated memorization and modifications over the years, which may allow a patient to access these plans even while under the stress associated with suicidal thinking. On the other hand, plans that address the near future, such as those expressed by Ms. D, are likely generated in response to current circumstances, which indicates the presence of adequate mental capacity to attend to the current situation, and hence, less preoccupation with suicidal thinking. There might be a neurologic basis for this: some evidence suggests that executive frontoparietal control is recruited in achievable, near-future planning, whereas abstract, difficult-to-achieve, more distant planning fails to engage these additional brain regions.23,24
Spontaneity and smooth expression
CASE 4
Mr. E, age 48, reassures his psychiatrist that he has no intent to act on his suicidal thoughts. When he is offered treatment options, he explains that he would like to start pharmacologic treatment because he only has a few weeks left before he relocates for a new job. The clinician discusses starting a specific medication, and Mr. E expresses interest unless the medication will interfere with his future position as a machine operator. Later, he declines social work assistance to establish care in his new location, preferring to first get the new health care insurance.
A smooth and noncalculated flow of future plans in a patient’s speech allows their plans to be more believable. Plans that naturally flow in response to a verbal exchange and without direct inquiry from the clinician are less likely to be confabulated. This leaves clinicians with the burden of improving the skill of subtly eliciting a patient’s future plans while avoiding directly asking about them. Directly inquiring about such plans may easily tip off the patient that their future planning is under investigation, which may result in misleading responses.
Although future plans that are expressed abruptly, without introductory verbal exchange, or are explicitly linked to why the patient doesn’t intend to kill themselves, can be genuine, the clinician may need to be skeptical about their significance during the risk evaluation. While facing such challenges, clinicians could attempt to shift the patient’s attention away from a safety and disposition-focused conversation toward a less goal-directed verbal exchange during which other opportunities for smooth expression of future plans may emerge. For example, if a patient suddenly discusses how much they care about X in attempt to emphasize why they are not contemplating suicide, the clinician may respond by gently asking the patient to talk more about X.
Continue to: Adopt a more nuanced approach...
Adopt a more nuanced approach
Assessment of the imminent risk of suicide is complicated and not well researched. A patient’s future planning can be used to better inform the evaluation. A patient may have a limited ability to generate future plans while contemplating suicide. Future plans that are specific, rich in details, achievable, dedicated to addressing the near future, and expressed smoothly and in a noncalculated fashion may be more reliable than other types of plans. The process of future planning may indicate low imminent suicide risk when it leads the patient to generate new plans to address current circumstances or the near future. When evaluating a patient’s imminent suicide risk, clinicians should consider abandoning a binary “is there future planning or not” approach and adopting a more complex, nuanced understanding to appropriately utilize this important factor in the risk assessment.
Bottom Line
A patient’s ability to plan for the future should be explored during an assessment of imminent suicide risk. Future plans that are specific, rich in details, achievable, dedicated to addressing the near future, and expressed smoothly and in a noncalculated fashion may be more reliable than other types of plans.
1. Gilbert AM, Garno JL, Braga RJ, et al. Clinical and cognitive correlates of suicide attempts in bipolar disorder: is suicide predictable? J Clin Psychiatry. 2011;72(8):1027-1033.
2. Obegi JH. Your patient refuses a suicide risk assessment. Now what? Current Psychiatry. 2021;20(4):45.
3. Blanchard M, Farber BA. “It is never okay to talk about suicide”: Patients’ reasons for concealing suicidal ideation in psychotherapy. Psychother Res. 2020;30(1):124-136.
4. Richards JE, Whiteside U, Ludman EJ, et al. Understanding why patients may not report suicidal ideation at a health care visit prior to a suicide attempt: a qualitative study. Psychiatr Serv. 2019;70(1):40-45.
5. Fulginiti A, Frey LM. Exploring suicide-related disclosure motivation and the impact on mechanisms linked to suicide. Death Stud. 2019;43(9):562-569.
6. Wilson CJ, Deane FP, Marshall KL, et al. Adolescents’ suicidal thinking and reluctance to consult general medical practitioners. J Youth Adolesc. 2010;39(4):343-356.
7. Eagles D, Stiell IG, Clement CM, et al. International survey of emergency physicians’ priorities for clinical decision rules. Acad Emerg Med. 2008;15(2):177-182.
8. Swedish Council on Health Technology Assessment (SBU): SBU Systematic Review Summaries. Instruments for Suicide Risk Assessment. Summary and Conclusions. SBU Yellow Report No. 242. 2015. Accessed January 6, 2021. https://www.ncbi.nlm.nih.gov/books/NBK350492/
9. Runeson B, Odeberg J, Pettersson A, et al. Instruments for the assessment of suicide risk: a systematic review evaluating the certainty of the evidence. PLoS One. 2017;12(7):e0180292. doi:10.1371/journal.pone.0180292
10. Steeg S, Quinlivan L, Nowland R, et al. Accuracy of risk scales for predicting repeat self-harm and suicide: a multicentre, population-level cohort study using routine clinical data. BMC Psychiatry. 2018;18(1):113.
11. Nock MK, Banaji MR. Prediction of suicide ideation and attempts among adolescents using a brief performance-based test. J Consult Clin Psychol. 2007;75(5):707-715.
12. Draper J, Murphy G, Vega E, et al. Helping callers to the National Suicide Prevention Lifeline who are at imminent risk of suicide: the importance of active engagement, active rescue, and collaboration between crisis and emergency services. Suicide Life Threat Behav. 2015;45(3):261-270.
13. Glenn CR, Nock MK. Improving the short-term prediction of suicidal behavior. Am J Prev Med. 2014;47(3 Suppl 2):S176-S180.
14. MacLeod AK, Pankhania B, Lee M, et al. Parasuicide, depression and the anticipation of positive and negative future experiences. Psychol Med. 1997;27(4):973-977.
15. MacLeod AK, Tata P, Evans K, et al. Recovery of positive future thinking within a high-risk parasuicide group: results from a pilot randomized controlled trial. Br J Clin Psychol. 1998;37(4):371-379.
16. MacLeod AK, Tata P, Tyrer P, et al. Hopelessness and positive and negative future thinking in parasuicide. Br J Clin Psychol. 2005;44(Pt 4):495-504.
17. O’Connor RC, Smyth R, Williams JM. Intrapersonal positive future thinking predicts repeat suicide attempts in hospital-treated suicide attempters. J Consult Clin Psychol. 2015;83(1):169-176.
18. O’Connor RC, Williams JMG. The relationship between positive future thinking, brooding, defeat and entrapment. Personality and Individual Differences. 2014;70:29-34.
19. Castaneda AE, Tuulio-Henriksson A, Marttunen M, et al. A review on cognitive impairments in depressive and anxiety disorders with a focus on young adults. J Affect Disord. 2008;106(1-2):1-27.
20. Austin MP, Mitchell P, Goodwin GM. Cognitive deficits in depression: possible implications for functional neuropathology. Br J Psychiatry. 2001;178:200-206.
21. Buoli M, Caldiroli A, Caletti E, et al. The impact of mood episodes and duration of illness on cognition in bipolar disorder. Compr Psychiatry. 2014;55(7):1561-1566.
22. Marzuk PM, Hartwell N, Leon AC, et al. Executive functioning in depressed patients with suicidal ideation. Acta Psychiatr Scand. 2005;112(4):294-301.
23. Spreng RN, Gerlach KD, Turner GR, et al. Autobiographical planning and the brain: activation and its modulation by qualitative features. J Cogn Neurosci. 2015;27(11):2147-2157.
24. Spreng RN, Sepulcre J, Turner GR, et al. Intrinsic architecture underlying the relations among the default, dorsal attention, and frontoparietal control networks of the human brain. J Cogn Neurosci. 2013;25(1):74-86.
A patient who has the ability to plan for their future can be reassuring for a clinician who is conducting an imminent suicide risk evaluation. However, that patient may report future plans even as they are contemplating suicide. Therefore, this variable should not be simplified categorically to the mere presence or absence of future plans. Such plans, and the process by which they are produced, should be examined more closely. In this article, we explore the relationship between a patient’s intent to die by suicide in the near future and their ability to maintain future planning. We also use case examples to highlight certain characteristics that may allow future planning to be integrated more reliably into the assessment of imminent risk of suicide.
An inherent challenge
Suicide risk assessment can be challenging due to the numerous factors that can contribute to a patient’s suicidal intent.1 Some individuals don’t seek help when they develop suicidal thoughts, and even among those who do, recognizing who may be at greater risk is not an easy task. Sometimes, this leads to inadequate interventions and a subsequent failure to ensure safety, or to an overreaction and unnecessary hospitalization.
A common difficulty is a patient’s unwillingness to cooperate with the examination.2 Some patients do not present voluntarily, while others may seek help but then conceal suicidal intent. In a sample of 66 psychotherapy patients who reported concealing suicidal ideation from their therapist and provided short essay responses explaining their motives for doing so, approximately 70% said fear of involuntary hospitalization was their motive to hide those thoughts from their doctor.3 Other reasons for concealment are shame, stigma, embarrassment, fear of rejection, and loss of autonomy.3-5 Moreover, higher levels of suicidal ideation are associated with treatment avoidance.6 Therefore, it is important to improve suicide predictability independent of the patient report. In a survey of 1,150 emergency physicians in Australasia, Canada, the United Kingdom, and the United States, the need for evidence-based guidelines on when to hospitalize a patient at risk for suicide was ranked as the 7th-highest priority.7 There are limitations to using suicide risk assessment scales,8,9 because scales designed to have high sensitivity are less specific, and those with high specificity fail to identify individuals at high risk.9,10 Most of the research conducted in this area has focused on the risk of suicide in 2 to 6 months, and not on imminent risk.11
What is ‘imminent’ risk?
There is no specific time definition for “imminent risk,” but the Lifeline Standards, Trainings, and Practices Subcommittee, a group of national and international experts in suicide prevention, defines imminent risk of suicide as the belief that there is a “close temporal connection between the person’s current risk status and actions that could lead to his/her suicide.”12 Practically, suicide could be considered imminent when it occurs within a few days of the evaluation. However, suicide may take place within a few days of an evaluation due to new life events or impulsive actions, which may explain why imminent risk of suicide can be difficult to define and predict. In clinical practice, there is little evidence-based knowledge about estimating imminent risk. Recent studies have explored certain aspects of a patient’s history in the attempt to improve imminent risk predictability.13 In light of the complexity of this matter and the lack of widely validated tools, clinicians are encouraged to share their experience with other clinicians while the efforts to advance evidence-based knowledge and tools continue.
The function of future planning
Future planning is a mental process embedded in several crucial executive functions. It operates on a daily basis to organize, prioritize, and carry out tasks to achieve day-to-day and more distant future goals. Some research has found that a decreased ability to generate positive future thoughts is linked to increased suicide risk in the long term.14-17 Positive future planning can be affected by even minor fluctuations in mood because the additional processing capacity needed during these mood changes may limit one’s ability to generate positive future thoughts.18 Patients experiencing mood episodes are known to experience cognitive dysfunctions.19-21 However, additional measurable cognitive changes have been detected in patients who are suicidal. For example, in a small study (N = 33) of patients with depression, those who were experiencing suicidal thoughts underperformed on several measures of executive functioning compared to patients with no suicidal ideation.22
However, when addressing imminent rather than future suicide risk, even neutral future plans—such as day-to-day plans or those addressing barriers to treatment—can be a meaningful indicator of the investment in one’s future beyond a potential near-term suicide, and therefore can be explored to further inform the risk evaluation. Significant mental resources can be consumed due to the level of distress associated with contemplating suicide, and therefore patients may have a reduced capacity for day-to-day planning. Thus, serious suicide contemplation is less likely in the presence of typical future planning.
Continue to: Characteristics of future planning...
Characteristics of future planning
Some patients may pretend to engage in future planning to indicate the absence of suicidal intent. This necessitates a more nuanced assessment of future plans beyond whether they exist or not by examining the genuineness of such plans, and the authenticity of the process by which they are produced. The Table lists 3 characteristics of future plans/future planning that, based on our clinical experience, can be helpful to evaluate during an imminent suicide risk evaluation. These are described in the following case examples.
Specificity and richness of details
CASE 1
Mr. A, a college student, presents to the emergency department (ED) complaining of depression and suicidal thoughts that he is able to dismiss. He would like to avoid starting a medication because he has finals in 2 weeks and is worried about adverse effects. He learned about cognitive-behavioral therapy and is interested in getting a referral to a specific office because it is located within a walking distance from campus and easy for him to access because he does not own a car.
The volume of details expressed in a patient’s future plans is important. The more detailed these plans are, the more likely the patient is invested in them. Attendance to the details, especially when addressing expected barriers to treatment, such as transportation, can be evidence of genuine future planning and subsequently of low imminent suicide risk. Spreng et al23 found that autobiographic plans that are more specific and richer in detail recruit additional brain regions that are not recruited in plans that are sparsely detailed or constructed from more generalized representations.
CASE 2
An ambulance transports Ms. B, age 42, from a primary care clinic to the ED because she has been having suicidal thoughts, with a plan to hang herself, for the past 2 days. During the evaluation, Ms. B denies having further suicidal thoughts and declines inpatient admission. She claims that she cannot be away from her children because she is their primary caretaker. Collateral information reveals that Ms. B’s mother has been caring for her children for the last 2 weeks because Ms. B has been too depressed to do so. She continues to refuse admission and is in tears while trying to explain how her absence due to inpatient treatment will be detrimental to her children. Eventually, she angrily accuses the clinician of abusing her children by forcing her to be hospitalized.
In an effort to conceal suicidal intent, patients may present obligations or excuses that would be an obstacle to psychiatric hospitalization. This might give a false perception of intact future planning. However, in these cases, patients often fail to volunteer details about their future plans or show evidence for actual attendance to their obligations. Due to the lack of tangible details to explain the negative effects of inpatient treatment, patients may compensate by using an exaggerated emotional response, with a strong emotional attachment to the obligation and severe distress over their potential inability to fulfill it due to a psychiatric hospitalization. This may contribute to concealing suicidal intent in a different way. A patient may be distressed by the prospect of losing their autonomy or ability to attempt suicide if hospitalized, and they may employ a false excuse as a substitute for the actual reason underlying their distress. A clinician may be falsely reassured if they do not accurately perceive the true cause of the emotional distress. Upon deeper exploration, the expressed emotional attachment is often found to be superficial and has little substantive support.
Continue to: Dedication to addressing acheivable goals in the near future...
Dedication to addressing achievable goals in the near future
CASE 3
Ms. C, age 15, survived a suicide attempt via a medication overdose. She says that she regrets what she did and is not planning to attempt suicide again. Ms. C says she no longer wants to die because in the future she wants to help people by becoming a nurse. She adds that there is a lot waiting for her because she wants to travel all over the world.
Ms. D, age 15, also survived a suicide attempt via a medication overdose. She also says that she regrets what she did and is not planning to attempt suicide again. Ms. D asks whether the physician would be willing to contact the school on her behalf to explain why she had to miss class and to ask for accommodations at school to assist with her panic attacks.
Future planning that involves a patient generating new plans to address current circumstances or the near future may be more reliable than future planning in which a patient repeats their previously constructed plans for the distant future. Eliciting more distant plans, such as a career or family-oriented decisions, indicates the ability to access these “memorized” plans rather than the ability to generate future plans.
Plans that address the distant future, such as those expressed by Ms. C, may have stronger neurologic imprints as a result of repeated memorization and modifications over the years, which may allow a patient to access these plans even while under the stress associated with suicidal thinking. On the other hand, plans that address the near future, such as those expressed by Ms. D, are likely generated in response to current circumstances, which indicates the presence of adequate mental capacity to attend to the current situation, and hence, less preoccupation with suicidal thinking. There might be a neurologic basis for this: some evidence suggests that executive frontoparietal control is recruited in achievable, near-future planning, whereas abstract, difficult-to-achieve, more distant planning fails to engage these additional brain regions.23,24
Spontaneity and smooth expression
CASE 4
Mr. E, age 48, reassures his psychiatrist that he has no intent to act on his suicidal thoughts. When he is offered treatment options, he explains that he would like to start pharmacologic treatment because he only has a few weeks left before he relocates for a new job. The clinician discusses starting a specific medication, and Mr. E expresses interest unless the medication will interfere with his future position as a machine operator. Later, he declines social work assistance to establish care in his new location, preferring to first get the new health care insurance.
A smooth and noncalculated flow of future plans in a patient’s speech allows their plans to be more believable. Plans that naturally flow in response to a verbal exchange and without direct inquiry from the clinician are less likely to be confabulated. This leaves clinicians with the burden of improving the skill of subtly eliciting a patient’s future plans while avoiding directly asking about them. Directly inquiring about such plans may easily tip off the patient that their future planning is under investigation, which may result in misleading responses.
Although future plans that are expressed abruptly, without introductory verbal exchange, or are explicitly linked to why the patient doesn’t intend to kill themselves, can be genuine, the clinician may need to be skeptical about their significance during the risk evaluation. While facing such challenges, clinicians could attempt to shift the patient’s attention away from a safety and disposition-focused conversation toward a less goal-directed verbal exchange during which other opportunities for smooth expression of future plans may emerge. For example, if a patient suddenly discusses how much they care about X in attempt to emphasize why they are not contemplating suicide, the clinician may respond by gently asking the patient to talk more about X.
Continue to: Adopt a more nuanced approach...
Adopt a more nuanced approach
Assessment of the imminent risk of suicide is complicated and not well researched. A patient’s future planning can be used to better inform the evaluation. A patient may have a limited ability to generate future plans while contemplating suicide. Future plans that are specific, rich in details, achievable, dedicated to addressing the near future, and expressed smoothly and in a noncalculated fashion may be more reliable than other types of plans. The process of future planning may indicate low imminent suicide risk when it leads the patient to generate new plans to address current circumstances or the near future. When evaluating a patient’s imminent suicide risk, clinicians should consider abandoning a binary “is there future planning or not” approach and adopting a more complex, nuanced understanding to appropriately utilize this important factor in the risk assessment.
Bottom Line
A patient’s ability to plan for the future should be explored during an assessment of imminent suicide risk. Future plans that are specific, rich in details, achievable, dedicated to addressing the near future, and expressed smoothly and in a noncalculated fashion may be more reliable than other types of plans.
A patient who has the ability to plan for their future can be reassuring for a clinician who is conducting an imminent suicide risk evaluation. However, that patient may report future plans even as they are contemplating suicide. Therefore, this variable should not be simplified categorically to the mere presence or absence of future plans. Such plans, and the process by which they are produced, should be examined more closely. In this article, we explore the relationship between a patient’s intent to die by suicide in the near future and their ability to maintain future planning. We also use case examples to highlight certain characteristics that may allow future planning to be integrated more reliably into the assessment of imminent risk of suicide.
An inherent challenge
Suicide risk assessment can be challenging due to the numerous factors that can contribute to a patient’s suicidal intent.1 Some individuals don’t seek help when they develop suicidal thoughts, and even among those who do, recognizing who may be at greater risk is not an easy task. Sometimes, this leads to inadequate interventions and a subsequent failure to ensure safety, or to an overreaction and unnecessary hospitalization.
A common difficulty is a patient’s unwillingness to cooperate with the examination.2 Some patients do not present voluntarily, while others may seek help but then conceal suicidal intent. In a sample of 66 psychotherapy patients who reported concealing suicidal ideation from their therapist and provided short essay responses explaining their motives for doing so, approximately 70% said fear of involuntary hospitalization was their motive to hide those thoughts from their doctor.3 Other reasons for concealment are shame, stigma, embarrassment, fear of rejection, and loss of autonomy.3-5 Moreover, higher levels of suicidal ideation are associated with treatment avoidance.6 Therefore, it is important to improve suicide predictability independent of the patient report. In a survey of 1,150 emergency physicians in Australasia, Canada, the United Kingdom, and the United States, the need for evidence-based guidelines on when to hospitalize a patient at risk for suicide was ranked as the 7th-highest priority.7 There are limitations to using suicide risk assessment scales,8,9 because scales designed to have high sensitivity are less specific, and those with high specificity fail to identify individuals at high risk.9,10 Most of the research conducted in this area has focused on the risk of suicide in 2 to 6 months, and not on imminent risk.11
What is ‘imminent’ risk?
There is no specific time definition for “imminent risk,” but the Lifeline Standards, Trainings, and Practices Subcommittee, a group of national and international experts in suicide prevention, defines imminent risk of suicide as the belief that there is a “close temporal connection between the person’s current risk status and actions that could lead to his/her suicide.”12 Practically, suicide could be considered imminent when it occurs within a few days of the evaluation. However, suicide may take place within a few days of an evaluation due to new life events or impulsive actions, which may explain why imminent risk of suicide can be difficult to define and predict. In clinical practice, there is little evidence-based knowledge about estimating imminent risk. Recent studies have explored certain aspects of a patient’s history in the attempt to improve imminent risk predictability.13 In light of the complexity of this matter and the lack of widely validated tools, clinicians are encouraged to share their experience with other clinicians while the efforts to advance evidence-based knowledge and tools continue.
The function of future planning
Future planning is a mental process embedded in several crucial executive functions. It operates on a daily basis to organize, prioritize, and carry out tasks to achieve day-to-day and more distant future goals. Some research has found that a decreased ability to generate positive future thoughts is linked to increased suicide risk in the long term.14-17 Positive future planning can be affected by even minor fluctuations in mood because the additional processing capacity needed during these mood changes may limit one’s ability to generate positive future thoughts.18 Patients experiencing mood episodes are known to experience cognitive dysfunctions.19-21 However, additional measurable cognitive changes have been detected in patients who are suicidal. For example, in a small study (N = 33) of patients with depression, those who were experiencing suicidal thoughts underperformed on several measures of executive functioning compared to patients with no suicidal ideation.22
However, when addressing imminent rather than future suicide risk, even neutral future plans—such as day-to-day plans or those addressing barriers to treatment—can be a meaningful indicator of the investment in one’s future beyond a potential near-term suicide, and therefore can be explored to further inform the risk evaluation. Significant mental resources can be consumed due to the level of distress associated with contemplating suicide, and therefore patients may have a reduced capacity for day-to-day planning. Thus, serious suicide contemplation is less likely in the presence of typical future planning.
Continue to: Characteristics of future planning...
Characteristics of future planning
Some patients may pretend to engage in future planning to indicate the absence of suicidal intent. This necessitates a more nuanced assessment of future plans beyond whether they exist or not by examining the genuineness of such plans, and the authenticity of the process by which they are produced. The Table lists 3 characteristics of future plans/future planning that, based on our clinical experience, can be helpful to evaluate during an imminent suicide risk evaluation. These are described in the following case examples.
Specificity and richness of details
CASE 1
Mr. A, a college student, presents to the emergency department (ED) complaining of depression and suicidal thoughts that he is able to dismiss. He would like to avoid starting a medication because he has finals in 2 weeks and is worried about adverse effects. He learned about cognitive-behavioral therapy and is interested in getting a referral to a specific office because it is located within a walking distance from campus and easy for him to access because he does not own a car.
The volume of details expressed in a patient’s future plans is important. The more detailed these plans are, the more likely the patient is invested in them. Attendance to the details, especially when addressing expected barriers to treatment, such as transportation, can be evidence of genuine future planning and subsequently of low imminent suicide risk. Spreng et al23 found that autobiographic plans that are more specific and richer in detail recruit additional brain regions that are not recruited in plans that are sparsely detailed or constructed from more generalized representations.
CASE 2
An ambulance transports Ms. B, age 42, from a primary care clinic to the ED because she has been having suicidal thoughts, with a plan to hang herself, for the past 2 days. During the evaluation, Ms. B denies having further suicidal thoughts and declines inpatient admission. She claims that she cannot be away from her children because she is their primary caretaker. Collateral information reveals that Ms. B’s mother has been caring for her children for the last 2 weeks because Ms. B has been too depressed to do so. She continues to refuse admission and is in tears while trying to explain how her absence due to inpatient treatment will be detrimental to her children. Eventually, she angrily accuses the clinician of abusing her children by forcing her to be hospitalized.
In an effort to conceal suicidal intent, patients may present obligations or excuses that would be an obstacle to psychiatric hospitalization. This might give a false perception of intact future planning. However, in these cases, patients often fail to volunteer details about their future plans or show evidence for actual attendance to their obligations. Due to the lack of tangible details to explain the negative effects of inpatient treatment, patients may compensate by using an exaggerated emotional response, with a strong emotional attachment to the obligation and severe distress over their potential inability to fulfill it due to a psychiatric hospitalization. This may contribute to concealing suicidal intent in a different way. A patient may be distressed by the prospect of losing their autonomy or ability to attempt suicide if hospitalized, and they may employ a false excuse as a substitute for the actual reason underlying their distress. A clinician may be falsely reassured if they do not accurately perceive the true cause of the emotional distress. Upon deeper exploration, the expressed emotional attachment is often found to be superficial and has little substantive support.
Continue to: Dedication to addressing acheivable goals in the near future...
Dedication to addressing achievable goals in the near future
CASE 3
Ms. C, age 15, survived a suicide attempt via a medication overdose. She says that she regrets what she did and is not planning to attempt suicide again. Ms. C says she no longer wants to die because in the future she wants to help people by becoming a nurse. She adds that there is a lot waiting for her because she wants to travel all over the world.
Ms. D, age 15, also survived a suicide attempt via a medication overdose. She also says that she regrets what she did and is not planning to attempt suicide again. Ms. D asks whether the physician would be willing to contact the school on her behalf to explain why she had to miss class and to ask for accommodations at school to assist with her panic attacks.
Future planning that involves a patient generating new plans to address current circumstances or the near future may be more reliable than future planning in which a patient repeats their previously constructed plans for the distant future. Eliciting more distant plans, such as a career or family-oriented decisions, indicates the ability to access these “memorized” plans rather than the ability to generate future plans.
Plans that address the distant future, such as those expressed by Ms. C, may have stronger neurologic imprints as a result of repeated memorization and modifications over the years, which may allow a patient to access these plans even while under the stress associated with suicidal thinking. On the other hand, plans that address the near future, such as those expressed by Ms. D, are likely generated in response to current circumstances, which indicates the presence of adequate mental capacity to attend to the current situation, and hence, less preoccupation with suicidal thinking. There might be a neurologic basis for this: some evidence suggests that executive frontoparietal control is recruited in achievable, near-future planning, whereas abstract, difficult-to-achieve, more distant planning fails to engage these additional brain regions.23,24
Spontaneity and smooth expression
CASE 4
Mr. E, age 48, reassures his psychiatrist that he has no intent to act on his suicidal thoughts. When he is offered treatment options, he explains that he would like to start pharmacologic treatment because he only has a few weeks left before he relocates for a new job. The clinician discusses starting a specific medication, and Mr. E expresses interest unless the medication will interfere with his future position as a machine operator. Later, he declines social work assistance to establish care in his new location, preferring to first get the new health care insurance.
A smooth and noncalculated flow of future plans in a patient’s speech allows their plans to be more believable. Plans that naturally flow in response to a verbal exchange and without direct inquiry from the clinician are less likely to be confabulated. This leaves clinicians with the burden of improving the skill of subtly eliciting a patient’s future plans while avoiding directly asking about them. Directly inquiring about such plans may easily tip off the patient that their future planning is under investigation, which may result in misleading responses.
Although future plans that are expressed abruptly, without introductory verbal exchange, or are explicitly linked to why the patient doesn’t intend to kill themselves, can be genuine, the clinician may need to be skeptical about their significance during the risk evaluation. While facing such challenges, clinicians could attempt to shift the patient’s attention away from a safety and disposition-focused conversation toward a less goal-directed verbal exchange during which other opportunities for smooth expression of future plans may emerge. For example, if a patient suddenly discusses how much they care about X in attempt to emphasize why they are not contemplating suicide, the clinician may respond by gently asking the patient to talk more about X.
Continue to: Adopt a more nuanced approach...
Adopt a more nuanced approach
Assessment of the imminent risk of suicide is complicated and not well researched. A patient’s future planning can be used to better inform the evaluation. A patient may have a limited ability to generate future plans while contemplating suicide. Future plans that are specific, rich in details, achievable, dedicated to addressing the near future, and expressed smoothly and in a noncalculated fashion may be more reliable than other types of plans. The process of future planning may indicate low imminent suicide risk when it leads the patient to generate new plans to address current circumstances or the near future. When evaluating a patient’s imminent suicide risk, clinicians should consider abandoning a binary “is there future planning or not” approach and adopting a more complex, nuanced understanding to appropriately utilize this important factor in the risk assessment.
Bottom Line
A patient’s ability to plan for the future should be explored during an assessment of imminent suicide risk. Future plans that are specific, rich in details, achievable, dedicated to addressing the near future, and expressed smoothly and in a noncalculated fashion may be more reliable than other types of plans.
1. Gilbert AM, Garno JL, Braga RJ, et al. Clinical and cognitive correlates of suicide attempts in bipolar disorder: is suicide predictable? J Clin Psychiatry. 2011;72(8):1027-1033.
2. Obegi JH. Your patient refuses a suicide risk assessment. Now what? Current Psychiatry. 2021;20(4):45.
3. Blanchard M, Farber BA. “It is never okay to talk about suicide”: Patients’ reasons for concealing suicidal ideation in psychotherapy. Psychother Res. 2020;30(1):124-136.
4. Richards JE, Whiteside U, Ludman EJ, et al. Understanding why patients may not report suicidal ideation at a health care visit prior to a suicide attempt: a qualitative study. Psychiatr Serv. 2019;70(1):40-45.
5. Fulginiti A, Frey LM. Exploring suicide-related disclosure motivation and the impact on mechanisms linked to suicide. Death Stud. 2019;43(9):562-569.
6. Wilson CJ, Deane FP, Marshall KL, et al. Adolescents’ suicidal thinking and reluctance to consult general medical practitioners. J Youth Adolesc. 2010;39(4):343-356.
7. Eagles D, Stiell IG, Clement CM, et al. International survey of emergency physicians’ priorities for clinical decision rules. Acad Emerg Med. 2008;15(2):177-182.
8. Swedish Council on Health Technology Assessment (SBU): SBU Systematic Review Summaries. Instruments for Suicide Risk Assessment. Summary and Conclusions. SBU Yellow Report No. 242. 2015. Accessed January 6, 2021. https://www.ncbi.nlm.nih.gov/books/NBK350492/
9. Runeson B, Odeberg J, Pettersson A, et al. Instruments for the assessment of suicide risk: a systematic review evaluating the certainty of the evidence. PLoS One. 2017;12(7):e0180292. doi:10.1371/journal.pone.0180292
10. Steeg S, Quinlivan L, Nowland R, et al. Accuracy of risk scales for predicting repeat self-harm and suicide: a multicentre, population-level cohort study using routine clinical data. BMC Psychiatry. 2018;18(1):113.
11. Nock MK, Banaji MR. Prediction of suicide ideation and attempts among adolescents using a brief performance-based test. J Consult Clin Psychol. 2007;75(5):707-715.
12. Draper J, Murphy G, Vega E, et al. Helping callers to the National Suicide Prevention Lifeline who are at imminent risk of suicide: the importance of active engagement, active rescue, and collaboration between crisis and emergency services. Suicide Life Threat Behav. 2015;45(3):261-270.
13. Glenn CR, Nock MK. Improving the short-term prediction of suicidal behavior. Am J Prev Med. 2014;47(3 Suppl 2):S176-S180.
14. MacLeod AK, Pankhania B, Lee M, et al. Parasuicide, depression and the anticipation of positive and negative future experiences. Psychol Med. 1997;27(4):973-977.
15. MacLeod AK, Tata P, Evans K, et al. Recovery of positive future thinking within a high-risk parasuicide group: results from a pilot randomized controlled trial. Br J Clin Psychol. 1998;37(4):371-379.
16. MacLeod AK, Tata P, Tyrer P, et al. Hopelessness and positive and negative future thinking in parasuicide. Br J Clin Psychol. 2005;44(Pt 4):495-504.
17. O’Connor RC, Smyth R, Williams JM. Intrapersonal positive future thinking predicts repeat suicide attempts in hospital-treated suicide attempters. J Consult Clin Psychol. 2015;83(1):169-176.
18. O’Connor RC, Williams JMG. The relationship between positive future thinking, brooding, defeat and entrapment. Personality and Individual Differences. 2014;70:29-34.
19. Castaneda AE, Tuulio-Henriksson A, Marttunen M, et al. A review on cognitive impairments in depressive and anxiety disorders with a focus on young adults. J Affect Disord. 2008;106(1-2):1-27.
20. Austin MP, Mitchell P, Goodwin GM. Cognitive deficits in depression: possible implications for functional neuropathology. Br J Psychiatry. 2001;178:200-206.
21. Buoli M, Caldiroli A, Caletti E, et al. The impact of mood episodes and duration of illness on cognition in bipolar disorder. Compr Psychiatry. 2014;55(7):1561-1566.
22. Marzuk PM, Hartwell N, Leon AC, et al. Executive functioning in depressed patients with suicidal ideation. Acta Psychiatr Scand. 2005;112(4):294-301.
23. Spreng RN, Gerlach KD, Turner GR, et al. Autobiographical planning and the brain: activation and its modulation by qualitative features. J Cogn Neurosci. 2015;27(11):2147-2157.
24. Spreng RN, Sepulcre J, Turner GR, et al. Intrinsic architecture underlying the relations among the default, dorsal attention, and frontoparietal control networks of the human brain. J Cogn Neurosci. 2013;25(1):74-86.
1. Gilbert AM, Garno JL, Braga RJ, et al. Clinical and cognitive correlates of suicide attempts in bipolar disorder: is suicide predictable? J Clin Psychiatry. 2011;72(8):1027-1033.
2. Obegi JH. Your patient refuses a suicide risk assessment. Now what? Current Psychiatry. 2021;20(4):45.
3. Blanchard M, Farber BA. “It is never okay to talk about suicide”: Patients’ reasons for concealing suicidal ideation in psychotherapy. Psychother Res. 2020;30(1):124-136.
4. Richards JE, Whiteside U, Ludman EJ, et al. Understanding why patients may not report suicidal ideation at a health care visit prior to a suicide attempt: a qualitative study. Psychiatr Serv. 2019;70(1):40-45.
5. Fulginiti A, Frey LM. Exploring suicide-related disclosure motivation and the impact on mechanisms linked to suicide. Death Stud. 2019;43(9):562-569.
6. Wilson CJ, Deane FP, Marshall KL, et al. Adolescents’ suicidal thinking and reluctance to consult general medical practitioners. J Youth Adolesc. 2010;39(4):343-356.
7. Eagles D, Stiell IG, Clement CM, et al. International survey of emergency physicians’ priorities for clinical decision rules. Acad Emerg Med. 2008;15(2):177-182.
8. Swedish Council on Health Technology Assessment (SBU): SBU Systematic Review Summaries. Instruments for Suicide Risk Assessment. Summary and Conclusions. SBU Yellow Report No. 242. 2015. Accessed January 6, 2021. https://www.ncbi.nlm.nih.gov/books/NBK350492/
9. Runeson B, Odeberg J, Pettersson A, et al. Instruments for the assessment of suicide risk: a systematic review evaluating the certainty of the evidence. PLoS One. 2017;12(7):e0180292. doi:10.1371/journal.pone.0180292
10. Steeg S, Quinlivan L, Nowland R, et al. Accuracy of risk scales for predicting repeat self-harm and suicide: a multicentre, population-level cohort study using routine clinical data. BMC Psychiatry. 2018;18(1):113.
11. Nock MK, Banaji MR. Prediction of suicide ideation and attempts among adolescents using a brief performance-based test. J Consult Clin Psychol. 2007;75(5):707-715.
12. Draper J, Murphy G, Vega E, et al. Helping callers to the National Suicide Prevention Lifeline who are at imminent risk of suicide: the importance of active engagement, active rescue, and collaboration between crisis and emergency services. Suicide Life Threat Behav. 2015;45(3):261-270.
13. Glenn CR, Nock MK. Improving the short-term prediction of suicidal behavior. Am J Prev Med. 2014;47(3 Suppl 2):S176-S180.
14. MacLeod AK, Pankhania B, Lee M, et al. Parasuicide, depression and the anticipation of positive and negative future experiences. Psychol Med. 1997;27(4):973-977.
15. MacLeod AK, Tata P, Evans K, et al. Recovery of positive future thinking within a high-risk parasuicide group: results from a pilot randomized controlled trial. Br J Clin Psychol. 1998;37(4):371-379.
16. MacLeod AK, Tata P, Tyrer P, et al. Hopelessness and positive and negative future thinking in parasuicide. Br J Clin Psychol. 2005;44(Pt 4):495-504.
17. O’Connor RC, Smyth R, Williams JM. Intrapersonal positive future thinking predicts repeat suicide attempts in hospital-treated suicide attempters. J Consult Clin Psychol. 2015;83(1):169-176.
18. O’Connor RC, Williams JMG. The relationship between positive future thinking, brooding, defeat and entrapment. Personality and Individual Differences. 2014;70:29-34.
19. Castaneda AE, Tuulio-Henriksson A, Marttunen M, et al. A review on cognitive impairments in depressive and anxiety disorders with a focus on young adults. J Affect Disord. 2008;106(1-2):1-27.
20. Austin MP, Mitchell P, Goodwin GM. Cognitive deficits in depression: possible implications for functional neuropathology. Br J Psychiatry. 2001;178:200-206.
21. Buoli M, Caldiroli A, Caletti E, et al. The impact of mood episodes and duration of illness on cognition in bipolar disorder. Compr Psychiatry. 2014;55(7):1561-1566.
22. Marzuk PM, Hartwell N, Leon AC, et al. Executive functioning in depressed patients with suicidal ideation. Acta Psychiatr Scand. 2005;112(4):294-301.
23. Spreng RN, Gerlach KD, Turner GR, et al. Autobiographical planning and the brain: activation and its modulation by qualitative features. J Cogn Neurosci. 2015;27(11):2147-2157.
24. Spreng RN, Sepulcre J, Turner GR, et al. Intrinsic architecture underlying the relations among the default, dorsal attention, and frontoparietal control networks of the human brain. J Cogn Neurosci. 2013;25(1):74-86.
Borderline personality disorder: 6 studies of psychosocial interventions
SECOND OF 2 PARTS
Borderline personality disorder (BPD) is associated with serious impairment in psychosocial functioning.1 It is characterized by an ongoing pattern of mood instability, cognitive distortions, problems with self-image, and impulsive behavior that often results in problems in relationships. As a result, patients with BPD tend to utilize more mental health services than patients with other personality disorders or major depressive disorder.2
Some clinicians believe BPD is difficult to treat. While historically there has been little consensus on the best treatments for this disorder, current options include both pharmacologic and psychological interventions. In Part 1 of this 2-part article, we focused on 6 studies that evaluated biological interventions.3 Here in Part 2, we focus on findings from 6 recent randomized controlled trials (RCTs) of psychosocial interventions for BPD
1. Zanarini MC, Conkey LC, Temes CM, et al. Randomized controlled trial of web-based psychoeducation for women with borderline personality disorder. J Clin Psychiatry. 2018;79(3):16m11153. doi: 10.4088/JCP.16m11153
Research has shown that BPD is a treatable illness with a more favorable prognosis than previously believed. Despite this, patients often experience difficulty accessing the most up-to-date information on BPD, which can impede their treatment. A 2008 study by Zanarini et al10 of younger female patients with BPD demonstrated that immediate, in-person psychoeducation improved impulsivity and relationships. Widespread implementation of this program proved problematic, however, due to cost and personnel constraints. To resolve this issue, researchers developed an internet-based version of the program. In a 2018 follow-up study, Zanarini et al4 examined the effect of this internet-based psychoeducation program on symptoms of BPD.
Continue to: Study design...
Study design
- Women (age 18 to 30) who met DSM-IV and Diagnostic Interview for Borderlines–Revised criteria for BPD were randomized to an internet-based psychoeducation treatment group (n = 40) or a control group (n = 40).
- Ten outcomes concerning symptom severity and psychosocial functioning were assessed during weeks 1 to 12 (acute phase) and at months 6, 9, and 12 (maintenance phase) using the self-report version of the Zanarini Rating Scale for BPD (ZAN-BPD), the Borderline Evaluation of Severity over Time, the Sheehan Disability Scale, the Clinically Useful Depression Outcome Scale, the Clinically Useful Anxiety Outcome Scale, and Weissman’s Social Adjustment Scale (SAS).
Outcomes
- In the acute phase, treatment group participants experienced statistically significant improvements in all 10 outcomes. Control group participants demonstrated similar results, achieving statistically significant improvements in 7 of 10 outcomes.
- Compared to the control group, the treatment group experienced a more significant reduction in impulsivity and improvement in psychosocial functioning as measured by the ZAN-BPD and SAS.
- In the maintenance phase, treatment group participants achieved statistically significant improvements in 9 of 10 outcomes, whereas control group participants demonstrated statistically significant improvements in only 3 of 10 outcomes.
- Compared to the control group, the treatment group also demonstrated a significantly greater improvement in all 4 sector scores and the total score of the ZAN-BP
Conclusions/limitations
- In patients with BPD, internet-based psychoeducation reduced symptom severity and improved psychosocial functioning, with effects lasting 1 year. Treatment group participants experienced clinically significant improvements in all outcomes measured during the acute phase of the study; most improvements were maintained over 1 year.
- While the control group initially saw similar improvements in most measurements, these improvements were not maintained as effectively over 1 year.
- Limitations include a female-only population, the restricted age range of participants, and recruitment exclusively from volunteers.
2. McMain SF, Guimond T, Barnhart R, et al. A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. Acta Psychiatr Scand. 2017;135(2):138-148.
Standard dialectical behavior therapy (DBT) is an effective treatment for BPD; however, access is often limited by shortages of clinicians and resources. Therefore, it has become increasingly common for clinical settings to offer patients only the skills training component of DBT, which requires fewer resources. While several clinical trials examining brief DBT skills–only treatment for BPD have shown promising results, it is unclear how effective this intervention is at reducing suicidal or nonsuicidal self-injury (NSSI) episodes. McMain et al5 explored the effectiveness of brief DBT skills–only adjunctive treatment on the rates of suicidal and NSSI episodes in patients with BPD.
Study design
- In this 2-arm, single-blind, prospective controlled trial, 84 adults who met DSM-IV criteria for BPD were randomized to a 20-week DBT skills training group (DBT group) or an active waitlist (WL group). No restrictions on additional psychosocial or pharmacologic treatments were imposed on either group.
- The primary outcome was the frequency of suicidal and NSSI episodes as measured by the Lifetime Suicide Attempt Self-Injury Interview and the Deliberate Self-Harm Inventory (DSHI). Measurements occurred at baseline, 10 weeks, 20 weeks, and 3 months posttreatment (32 weeks).
- Secondary outcomes included changes in health care utilization, BPD symptoms, and coping. These were assessed using the Treatment History Interview-2, Borderline Symptom List-23, State-Trait Anger Expression Inventory, Symptom Checklist-90-revised (SCL-90-R), Barratt Impulsiveness Scale-11, Beck Depression Inventory (BDI)-II, Social Adjustment Scale Self-report, Difficulties in Emotion Regulation Scale, Distress Tolerance Scale, and Kentucky Inventory of Mindfulness Scale.
Outcomes
- At Week 32, compared to the WL group, the DBT group showed statistically significant greater reductions in the frequency of suicidal and NSSI episodes as measured by the LSASI but not by the DSHI. The DBT group experienced statistically significant improvements in distress tolerance and emotion regulation over the WL group at all points, but no difference on mindfulness. The DBT group achieved greater reductions in anger over time as compared to the WL group.
- At Week 20, compared to the WL group, the DBT group showed significant improvements in social adjustment, symptom distress, and borderline symptoms. There were no significant group differences on impulsivity. Between-group differences in the number of hospital admissions favored the DBT group at 10 and 20 weeks, but not at 32 weeks. There was no statistically significant difference between the groups with respect to the number of emergency department visits.
- Analyses of group differences in clinical improvement as measured by the SCL-90-R revealed statistically reliable and clinically significant changes in the DBT group over the WL group at 20 weeks, but not at 32 weeks.
Conclusions/limitations
- Brief DBT skills training reduced suicidal and NSSI episodes in patients with BPD. Participants in the DBT group also demonstrated greater improvement in anger, distress tolerance, and emotion regulation compared to the control group. These results were evident 3 months after treatment. However, any gains in health care utilization, social adjustment, symptom distress, and borderline symptoms diminished or did not differ from waitlist participants at Week 32. At that time, participants in the DBT group demonstrated a similar level of symptomatology as the WL group.
- Limitations include the use of an active waitlist control group, allowance of concurrent treatments, the absence of an active therapeutic comparator group, use of self-report measures, use of an instrument with unknown psychometric properties, and a relatively short 3-month follow-up period.
3. Bozzatello P, Bellino S. Combined therapy with interpersonal psychotherapy adapted for borderline personality disorder: a two-years follow-up. Psychiatry Res. 2016;240:151-156.
Psychotherapeutic options for treating BPD include DBT, mentalization-based treatment, schema-focused therapy, transference-based psychotherapy, and systems training for emotional predictability and problem solving. More recently, interpersonal therapy also has been adapted for BPD (IPT-BPD). However, thus far no trials have investigated the long-term effects of this therapy on BPD. In 2010, Bellino et al11 published a 32-week RCT examining the effect of IPT-BPD on BPD. They concluded that IPT-BPD plus fluoxetine was superior to fluoxetine alone in improving symptoms and quality of life. The present study by Bozzatello et al6 examined whether the benefits of IPT-BPD plus fluoxetine demonstrated in the 2010 study persisted over a 24-month follow-up.
Continue to: Study design...
Study design
- In the 2010 study by Bellino et al,11 55 outpatients who met DSM-IV criteria for BPD were randomized to receive IPT-BPD plus fluoxetine (combined therapy) or fluoxetine alone for 32 weeks. Forty-four participants completed a 24-month follow-up study (n = 22 for IPT-BPD plus fluoxetine, n = 22 for fluoxetine only).
- Clinical assessments were performed at 6, 12, and 24 months, and used the same instruments as the original study, including the Clinical Global Impression Scale–Severity item, Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale (HARS), Social and Occupational Functioning Assessment, Satisfaction Profile (SAT-P), and the Borderline Personality Disorder Severity Index (BPDSI).
Outcomes
- While the original study demonstrated that combined therapy had a clinically significant effect over fluoxetine alone on both HARS score and the BPDSI item “affective instability” at 32 weeks, this advantage was maintained only at the 6-month assessment.
- The improvements that the combined therapy provided over fluoxetine monotherapy on the BPDSI items of “impulsivity” and “interpersonal relationships” as well as the SAT-P factors of social and psychological functioning at 32 weeks were preserved at 24 months. No additional improvements were seen.
Conclusions/limitations
- The improvements in impulsivity, interpersonal functioning, social functioning, and psychological functioning at 32 weeks seen with IPT-BPD plus fluoxetine compared with fluoxetine alone persisted for 2 years after completing therapy; no further improvements were seen.
- The improvements to anxiety and affective instability that combined therapy demonstrated over fluoxetine monotherapy at 32 weeks were not maintained at 24 months.
- Limitations include a small sample size, exclusion of psychiatric comorbidities, and a lack of assessment of session or medication adherence.
4. Antonsen BT, Kvarstein EH, Urnes Ø, et al. Favourable outcome of long-term combined psychotherapy for patients with borderline personality disorder: six-year follow-up of a randomized study. Psychother Res. 2017;27(1):51-63.
While many studies have demonstrated the benefits of psychotherapy for treating personality disorders, there is limited research of how different levels of psychotherapy may impact treatment outcomes. An RCT called the Ullevål Personality Project (UPP)12 compared an intensive combined treatment program (CP) with outpatient individual psychotherapy (OIP) in patients with personality disorders. The CP program consisted of short-term day-hospital treatment followed by outpatient combined group and individual psychotherapy. The outcomes this RCT evaluated included suicide attempts, suicidal thoughts, self-injury, psychosocial functioning, symptom distress, and interpersonal and personality problems. A 6-year follow-up concluded there were no differences in outcomes between the 2 treatment groups. However, in this RCT, Antonsen et al7 examined whether CP produced statistically significant benefits over OIP in a subset of patients with BPD.
Study design
- In the UPP trial,12 117 patients who met DSM-IV criteria for personality disorders (excluding antisocial and schizotypal personality disorder) were randomized to receive 18 weeks of day hospital psychotherapy followed by CP or OIP. Fifty-two participants in the UPP were diagnosed with BPD, and 34 of these participants completed the 6-year follow-up investigation.
- Symptom distress, psychosocial functioning, interpersonal problems, quality of life, personality functioning, and self-harm/suicidal thoughts/suicide attempts were assessed at baseline, 8 months, 18 months, 3 years, and 6 years using the SCL-90-R Global Severity Index (GSI), BDI, Global Assessment of Functioning (GAF), Work and Social Adjustment Scale (WSAS), Quality of Life 10-point scale (QOL), Circumplex of Interpersonal Problems (CIP), and the 60-item short form of the Severity Indices of Personality Problems (SIPP-118) questionnaire.
Outcomes
- Compared to the OIP group, the CP group demonstrated statistically significant reductions in symptom distress at Year 6 as measured by the SCL-90-R GSI. Between Years 3 and 6, the CP group continued to show improvements in psychosocial functioning as demonstrated by improvements in GAF and WSAS scores. The OIP group’s scores worsened during this time. Compared to the OIP group, participants in the CP group also had significantly better outcomes on the SIPP-118 domains of self-control and identity integration.
- There were no significant differences between groups on the proportion of participants who engaged in self-harm or experienced suicidal thoughts or attempts. There were no significant differences in outcomes between the treatment groups on the CIP, BDI, or QOL.
- Participants in CP group tended to use fewer psychotropic medications than those in the OIP group over time, but this difference was not statistically significant. The 2 groups did not differ in use of health care services over the last year.
- Avoidant personality disorder (AVPD) did not have a significant moderator effect on GAF score. Comorbid AVPD was a negative predictor of GAF score, independent of the group.
Conclusions/limitations
- Both groups experienced a remission rate of 90% at 6-year follow-up. Compared with the OIP group, participants in the CP group experienced significantly greater reductions in symptom distress and improvements in self-control and identity integration at 6 years. Between Years 3 and 6, participants in the CP group experienced significant improvements in psychosocial functioning compared with OIP group participants. The 2 groups did not differ on other outcomes, including the CIP, BDI, QOL, suicidal thoughts, suicidal attempts, self-harm, and health care utilization.
- Despite statistically significant differences in GAF scores favoring the CP group over the OIP group during Years 3 to 6, GAF scores did not differ significantly in the final year, which suggests that symptomatic remission does not equal functional improvement.
- Limitations include a lack of control for intensity or length of treatment in statistical analyses, small sample size, lack of correction for multiple testing, lack of an a priori power analysis, missing data and potential violation of the missing at random assumption, use of therapists’ preferred treatment method/practice, and a lack of control for other treatments.
5. Bateman A, Constantinou MP, Fonagy P, et al. Eight-year prospective follow-up of mentalization-based treatment versus structured clinical management for people with borderline personality disorder. Personal Disord. 2021;12(4):291-299.
The efficacy of various psychotherapies for symptoms of BPD has been well established. However, there is limited evidence that these effects persist over time. In 2009, Bateman et al13 conducted an 18-month RCT comparing the effectiveness of outpatient mentalization-based treatment (MBT) against structured clinical management (SCM) for patients with BPD. Both groups experienced substantial improvements, but patients assigned to MBT demonstrated greater improvement in clinically significant problems, including suicide attempts and hospitalizations. In a 2021 follow-up to this study, Bateman et al8 investigated whether the MBT group’s gains in the primary outcomes (absence of severe self-harm, suicide attempts, and inpatient admissions in the previous 12 months), social functioning, vocational engagement, and mental health service usage were maintained throughout an 8-year follow-up period.
Continue to: Study design...
Study design
- In the 2009 trial, Bateman et al13 randomized adult participants who met DSM-IV criteria for BPD and had a suicide attempt or episode of life-threatening self-harm in the past 6 months to receive 18 months of MBT or SCM. The primary outcome was crisis events, defined as a composite of suicidal and severe self-injurious behaviors and hospitalizations. The 2021 Bateman et al8 study expanded this investigation by collecting additional data on a yearly basis for 8 years.
- Of the 134 original participants, 98 agreed to complete the follow-up. Due to attrition, the follow-up period was limited to 8 years. At each yearly visit, researchers collected information on the primary outcome, the absence of severe self-harm, suicide attempts, and inpatient admissions in the previous 12 months.
- Secondary measures were collected mainly through a modified version of the Client Service Receipt Inventory and included critical incidents, psychiatric and medical hospital and community services, employment and other personally meaningful activity, psychoactive medication, and other mental health treatments.
Outcomes
- The number of participants who met diagnostic criteria for BPD at the 1-year follow-up was significantly lower in the MBT group compared with the SCM group. To improve participant retention, this outcome was not evaluated at later visits.
- The number of participants who achieved the primary recovery criteria of the original trial (absence of severe self-harm, suicide attempts, and inpatient admissions in the previous 12 months) and remained well throughout the entire follow-up period was significantly higher in the MBT group compared with the SCM group. The average number of years during which participants failed to meet recovery criteria was significantly greater in the SCM group compared with the MBT group.
- When controlling for age, treatment group was a significant predictor of recovery during the follow-up period. Overall, significantly fewer participants in the MBT group experienced critical incidents during the follow-up period.
- The SCM group used crisis mental health services for a significantly greater number of follow-up years than the MBT group, although the likelihood of ever using crisis services did not statistically differ between the groups. Both groups had similar use of outpatient mental health services, primary care services, and nonmental health medical services. Compared to the SCM group, the MBT group had significantly fewer professional support service visits and significantly fewer outpatient psychiatrist visits.
- MBT group participants spent more time in education, were less likely to be unemployed, and were less likely to use social care interventions than SCM group participants. Although those in the MBT group spent more months engaged in purposeful activity, there was no significant difference between the groups in the proportion of participants who did not engage in purposeful activity.
- The MBT group spent fewer months receiving psychotherapeutic medication compared with the SCM group. The variables that yielded significant 2-way interactions were eating disorder, substance use disorder, and physical abuse, suggesting greater benefit from MBT with these concurrent diagnoses. Younger age was associated with better outcomes.
Conclusions/limitations
- This study demonstrated that patients with BPD significantly benefited from specialized therapies such as MBT.
- At the 1 follow-up visit, the number of participants who met diagnostic criteria for BPD was significantly lower in the MBT group compared with the SCM group.
- The number of participants who had achieved the primary recovery criteria and remained well during the 8-year follow-up period was significantly higher in the MBT group compared to the SCM group.
- Limitations include increasing attrition over time, possible allegiance effects and unmasking of research assistants, lack of self-report questionnaires, and the potentially erroneous conclusion that increased use of services equates to poorer treatment response and greater need for support.
6. Klein JP, Hauer-von Mauschwitz A, Berger T, et al. Effectiveness and safety of the adjunctive use of an internet-based self-management intervention for borderline personality disorder in addition to care as usual: results from a randomised controlled trial. BMJ Open. 2021;11(9):e047771.
Fewer than 1 in 4 patients with BPD have access to effective psychotherapies. The use of internet-based self-management interventions (SMIs) developed from evidence-based psychotherapies can help close this treatment gap. Although the efficacy of SMIs for several mental disorders has been demonstrated in multiple meta-analyses, results for BPD are mixed. In this study, Klein et al9 examined the effectiveness and safety of the adjunctive use of an SMI based on schema therapy in addition to care as usual (CAU) in patients with BPD.
Study design
- In a 12-month, rater-blind, controlled parallel group trial, adults who had a total BPDSI score ≥15 and either a diagnosis of BPD according to DSM-IV criteria or a probable diagnosis of BPD (if they had also received a BPD diagnosis from their treating physician) were randomized to an internet-based SMI based on schema therapy called priovi (n = 103) or CAU (n = 101). Participants could complete the SMI content in approximately 6 months but were recommended to use the intervention for the entire year.
- Participation in psychotherapy and psychiatric treatment, including pharmacotherapy, was permitted. At baseline, 74% of participants were receiving psychotherapy and 88% were receiving psychiatric treatment.
- The primary outcome was change in BPDSI score at 12 months. The primary safety outcome was the number of serious adverse events at 12 months. Secondary outcomes included BPD severity, depressive symptoms, anxiety symptoms, quality of life, uncontrolled internet use, negative treatment effects, and satisfaction with the intervention. Most assessments were measured at baseline, 3 months, 6 months, 9 months, and 12 months.
Outcomes
- Large reductions in the severity of BPD symptoms as measured by change in BPDSI score was observed in both groups. Although the average reduction in BPDSI score was greater in the SMI group, this difference was not statistically significant from the CAU group.
- There was no statistically significant difference in the number of serious adverse events between groups at any time.
Conclusions/limitations
- Treatment with SMI did not result in improved outcomes over CAU. Although the average reduction in BPDSI score was greater in the SMI group compared to the CAU group, this difference was not statistically significant.
- The authors cautioned that the smaller-than-expected between-groups effect size must be interpreted against the background of an unexpectedly large effect in the CAU group. In fact, the CAU group pre/post effect was comparable to the pre/post effect of intensive specialized DBT treatment groups in previous RCTs.
- The authors also suggested that the high percentage of participants who received psychotherapy did not allow for an additional benefit from SMI.
- Limitations include recruitment method, lack of systematic assessment of accidental unblinding, high exclusion rate due to failure of the participant or treating clinician to provide confirmation of diagnosis, and the use of a serious adverse events assessment that is not psychometrically validated.
Bottom Line
Evidence from randomized controlled trials suggests that internet-based psychoeducation, brief dialectical behavior therapy skills-only treatment, interpersonal therapy, a program that combines day treatment with individual and group psychotherapy, and mentalization-based treatment can improve symptoms and quality of life for patients with borderline personality disorder.
1. Skodol AE, Gunderson JG, McGlashan TM, et al. Functional impairment in patients with schizotypal, borderline, avoidant, or obsessive-compulsive personality disorder. Am J Psychiatry. 2002;159(2):276-83.
2. Bender DS, Dolan RT, Skodol AE, et al. Treatment utilization by patients with personality disorders. Am J Psychiatry. 2001;158(2):295-302.
3. Saeed SA, Kallis AC. Borderline personality disorder: 6 studies of biological interventions. Current Psychiatry. 2021;20(11):26-30,34-36.
4. Zanarini MC, Conkey LC, Temes CM, et al. Randomized controlled trial of web-based psychoeducation for women with borderline personality disorder. J Clin Psychiatry. 2018;79(3):16m11153. doi:10.4088/JCP.16m11153
5. McMain SF, Guimond T, Barnhart R, et al. A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. Acta Psychiatr Scand. 2017;135(2):138-148. doi:10.1111/acps.12664
6. Bozzatello P, Bellino S. Combined therapy with interpersonal psychotherapy adapted for borderline personality disorder: a two-years follow-up. Psychiatry Res. 2016;240:151-156. doi:10.1016/j.psychres.2016.04.014
7. Antonsen BT, Kvarstein EH, Urnes Ø, et al. Favourable outcome of long-term combined psychotherapy for patients with borderline personality disorder: six-year follow-up of a randomized study. Psychother Res. 2017;27(1):51-63. doi:10.1080/10503307.2015.1072283
8. Bateman A, Constantinou MP, Fonagy P, et al. Eight-year prospective follow-up of mentalization-based treatment versus structured clinical management for people with borderline personality disorder. Personal Disord. 2021;12(4):291-299. doi:10.1037/per0000422
9. Klein JP, Hauer-von Mauschwitz A, Berger T, et al. Effectiveness and safety of the adjunctive use of an internet-based self-management intervention for borderline personality disorder in addition to care as usual: results from a randomised controlled trial. BMJ Open. 2021;11(9):e047771. doi:10.1136/bmjopen-2020-047771
10. Zanarini MC, Frankenburg FR. A preliminary, randomized trial of psychoeducation for women with borderline personality disorder. J Pers Disord. 2008;22(3):284-290.
11. Bellino S, Rinaldi C, Bogetto F. Adaptation of interpersonal psychotherapy to borderline personality disorder: a comparison of combined therapy and single pharmacotherapy. Can J Psychiatry. 2010;55(2):74-81.
12. Arnevik E, Wilberg T, Urnes Ø, et al. Psychotherapy for personality disorders: short-term day hospital psychotherapy versus outpatient individual therapy – a randomized controlled study. Eur Psychiatry. 2009,24(2):71-78. doi:10.1016/j.eurpsy.2008.09.004
13. Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009;166(12):1355-1364.
SECOND OF 2 PARTS
Borderline personality disorder (BPD) is associated with serious impairment in psychosocial functioning.1 It is characterized by an ongoing pattern of mood instability, cognitive distortions, problems with self-image, and impulsive behavior that often results in problems in relationships. As a result, patients with BPD tend to utilize more mental health services than patients with other personality disorders or major depressive disorder.2
Some clinicians believe BPD is difficult to treat. While historically there has been little consensus on the best treatments for this disorder, current options include both pharmacologic and psychological interventions. In Part 1 of this 2-part article, we focused on 6 studies that evaluated biological interventions.3 Here in Part 2, we focus on findings from 6 recent randomized controlled trials (RCTs) of psychosocial interventions for BPD
1. Zanarini MC, Conkey LC, Temes CM, et al. Randomized controlled trial of web-based psychoeducation for women with borderline personality disorder. J Clin Psychiatry. 2018;79(3):16m11153. doi: 10.4088/JCP.16m11153
Research has shown that BPD is a treatable illness with a more favorable prognosis than previously believed. Despite this, patients often experience difficulty accessing the most up-to-date information on BPD, which can impede their treatment. A 2008 study by Zanarini et al10 of younger female patients with BPD demonstrated that immediate, in-person psychoeducation improved impulsivity and relationships. Widespread implementation of this program proved problematic, however, due to cost and personnel constraints. To resolve this issue, researchers developed an internet-based version of the program. In a 2018 follow-up study, Zanarini et al4 examined the effect of this internet-based psychoeducation program on symptoms of BPD.
Continue to: Study design...
Study design
- Women (age 18 to 30) who met DSM-IV and Diagnostic Interview for Borderlines–Revised criteria for BPD were randomized to an internet-based psychoeducation treatment group (n = 40) or a control group (n = 40).
- Ten outcomes concerning symptom severity and psychosocial functioning were assessed during weeks 1 to 12 (acute phase) and at months 6, 9, and 12 (maintenance phase) using the self-report version of the Zanarini Rating Scale for BPD (ZAN-BPD), the Borderline Evaluation of Severity over Time, the Sheehan Disability Scale, the Clinically Useful Depression Outcome Scale, the Clinically Useful Anxiety Outcome Scale, and Weissman’s Social Adjustment Scale (SAS).
Outcomes
- In the acute phase, treatment group participants experienced statistically significant improvements in all 10 outcomes. Control group participants demonstrated similar results, achieving statistically significant improvements in 7 of 10 outcomes.
- Compared to the control group, the treatment group experienced a more significant reduction in impulsivity and improvement in psychosocial functioning as measured by the ZAN-BPD and SAS.
- In the maintenance phase, treatment group participants achieved statistically significant improvements in 9 of 10 outcomes, whereas control group participants demonstrated statistically significant improvements in only 3 of 10 outcomes.
- Compared to the control group, the treatment group also demonstrated a significantly greater improvement in all 4 sector scores and the total score of the ZAN-BP
Conclusions/limitations
- In patients with BPD, internet-based psychoeducation reduced symptom severity and improved psychosocial functioning, with effects lasting 1 year. Treatment group participants experienced clinically significant improvements in all outcomes measured during the acute phase of the study; most improvements were maintained over 1 year.
- While the control group initially saw similar improvements in most measurements, these improvements were not maintained as effectively over 1 year.
- Limitations include a female-only population, the restricted age range of participants, and recruitment exclusively from volunteers.
2. McMain SF, Guimond T, Barnhart R, et al. A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. Acta Psychiatr Scand. 2017;135(2):138-148.
Standard dialectical behavior therapy (DBT) is an effective treatment for BPD; however, access is often limited by shortages of clinicians and resources. Therefore, it has become increasingly common for clinical settings to offer patients only the skills training component of DBT, which requires fewer resources. While several clinical trials examining brief DBT skills–only treatment for BPD have shown promising results, it is unclear how effective this intervention is at reducing suicidal or nonsuicidal self-injury (NSSI) episodes. McMain et al5 explored the effectiveness of brief DBT skills–only adjunctive treatment on the rates of suicidal and NSSI episodes in patients with BPD.
Study design
- In this 2-arm, single-blind, prospective controlled trial, 84 adults who met DSM-IV criteria for BPD were randomized to a 20-week DBT skills training group (DBT group) or an active waitlist (WL group). No restrictions on additional psychosocial or pharmacologic treatments were imposed on either group.
- The primary outcome was the frequency of suicidal and NSSI episodes as measured by the Lifetime Suicide Attempt Self-Injury Interview and the Deliberate Self-Harm Inventory (DSHI). Measurements occurred at baseline, 10 weeks, 20 weeks, and 3 months posttreatment (32 weeks).
- Secondary outcomes included changes in health care utilization, BPD symptoms, and coping. These were assessed using the Treatment History Interview-2, Borderline Symptom List-23, State-Trait Anger Expression Inventory, Symptom Checklist-90-revised (SCL-90-R), Barratt Impulsiveness Scale-11, Beck Depression Inventory (BDI)-II, Social Adjustment Scale Self-report, Difficulties in Emotion Regulation Scale, Distress Tolerance Scale, and Kentucky Inventory of Mindfulness Scale.
Outcomes
- At Week 32, compared to the WL group, the DBT group showed statistically significant greater reductions in the frequency of suicidal and NSSI episodes as measured by the LSASI but not by the DSHI. The DBT group experienced statistically significant improvements in distress tolerance and emotion regulation over the WL group at all points, but no difference on mindfulness. The DBT group achieved greater reductions in anger over time as compared to the WL group.
- At Week 20, compared to the WL group, the DBT group showed significant improvements in social adjustment, symptom distress, and borderline symptoms. There were no significant group differences on impulsivity. Between-group differences in the number of hospital admissions favored the DBT group at 10 and 20 weeks, but not at 32 weeks. There was no statistically significant difference between the groups with respect to the number of emergency department visits.
- Analyses of group differences in clinical improvement as measured by the SCL-90-R revealed statistically reliable and clinically significant changes in the DBT group over the WL group at 20 weeks, but not at 32 weeks.
Conclusions/limitations
- Brief DBT skills training reduced suicidal and NSSI episodes in patients with BPD. Participants in the DBT group also demonstrated greater improvement in anger, distress tolerance, and emotion regulation compared to the control group. These results were evident 3 months after treatment. However, any gains in health care utilization, social adjustment, symptom distress, and borderline symptoms diminished or did not differ from waitlist participants at Week 32. At that time, participants in the DBT group demonstrated a similar level of symptomatology as the WL group.
- Limitations include the use of an active waitlist control group, allowance of concurrent treatments, the absence of an active therapeutic comparator group, use of self-report measures, use of an instrument with unknown psychometric properties, and a relatively short 3-month follow-up period.
3. Bozzatello P, Bellino S. Combined therapy with interpersonal psychotherapy adapted for borderline personality disorder: a two-years follow-up. Psychiatry Res. 2016;240:151-156.
Psychotherapeutic options for treating BPD include DBT, mentalization-based treatment, schema-focused therapy, transference-based psychotherapy, and systems training for emotional predictability and problem solving. More recently, interpersonal therapy also has been adapted for BPD (IPT-BPD). However, thus far no trials have investigated the long-term effects of this therapy on BPD. In 2010, Bellino et al11 published a 32-week RCT examining the effect of IPT-BPD on BPD. They concluded that IPT-BPD plus fluoxetine was superior to fluoxetine alone in improving symptoms and quality of life. The present study by Bozzatello et al6 examined whether the benefits of IPT-BPD plus fluoxetine demonstrated in the 2010 study persisted over a 24-month follow-up.
Continue to: Study design...
Study design
- In the 2010 study by Bellino et al,11 55 outpatients who met DSM-IV criteria for BPD were randomized to receive IPT-BPD plus fluoxetine (combined therapy) or fluoxetine alone for 32 weeks. Forty-four participants completed a 24-month follow-up study (n = 22 for IPT-BPD plus fluoxetine, n = 22 for fluoxetine only).
- Clinical assessments were performed at 6, 12, and 24 months, and used the same instruments as the original study, including the Clinical Global Impression Scale–Severity item, Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale (HARS), Social and Occupational Functioning Assessment, Satisfaction Profile (SAT-P), and the Borderline Personality Disorder Severity Index (BPDSI).
Outcomes
- While the original study demonstrated that combined therapy had a clinically significant effect over fluoxetine alone on both HARS score and the BPDSI item “affective instability” at 32 weeks, this advantage was maintained only at the 6-month assessment.
- The improvements that the combined therapy provided over fluoxetine monotherapy on the BPDSI items of “impulsivity” and “interpersonal relationships” as well as the SAT-P factors of social and psychological functioning at 32 weeks were preserved at 24 months. No additional improvements were seen.
Conclusions/limitations
- The improvements in impulsivity, interpersonal functioning, social functioning, and psychological functioning at 32 weeks seen with IPT-BPD plus fluoxetine compared with fluoxetine alone persisted for 2 years after completing therapy; no further improvements were seen.
- The improvements to anxiety and affective instability that combined therapy demonstrated over fluoxetine monotherapy at 32 weeks were not maintained at 24 months.
- Limitations include a small sample size, exclusion of psychiatric comorbidities, and a lack of assessment of session or medication adherence.
4. Antonsen BT, Kvarstein EH, Urnes Ø, et al. Favourable outcome of long-term combined psychotherapy for patients with borderline personality disorder: six-year follow-up of a randomized study. Psychother Res. 2017;27(1):51-63.
While many studies have demonstrated the benefits of psychotherapy for treating personality disorders, there is limited research of how different levels of psychotherapy may impact treatment outcomes. An RCT called the Ullevål Personality Project (UPP)12 compared an intensive combined treatment program (CP) with outpatient individual psychotherapy (OIP) in patients with personality disorders. The CP program consisted of short-term day-hospital treatment followed by outpatient combined group and individual psychotherapy. The outcomes this RCT evaluated included suicide attempts, suicidal thoughts, self-injury, psychosocial functioning, symptom distress, and interpersonal and personality problems. A 6-year follow-up concluded there were no differences in outcomes between the 2 treatment groups. However, in this RCT, Antonsen et al7 examined whether CP produced statistically significant benefits over OIP in a subset of patients with BPD.
Study design
- In the UPP trial,12 117 patients who met DSM-IV criteria for personality disorders (excluding antisocial and schizotypal personality disorder) were randomized to receive 18 weeks of day hospital psychotherapy followed by CP or OIP. Fifty-two participants in the UPP were diagnosed with BPD, and 34 of these participants completed the 6-year follow-up investigation.
- Symptom distress, psychosocial functioning, interpersonal problems, quality of life, personality functioning, and self-harm/suicidal thoughts/suicide attempts were assessed at baseline, 8 months, 18 months, 3 years, and 6 years using the SCL-90-R Global Severity Index (GSI), BDI, Global Assessment of Functioning (GAF), Work and Social Adjustment Scale (WSAS), Quality of Life 10-point scale (QOL), Circumplex of Interpersonal Problems (CIP), and the 60-item short form of the Severity Indices of Personality Problems (SIPP-118) questionnaire.
Outcomes
- Compared to the OIP group, the CP group demonstrated statistically significant reductions in symptom distress at Year 6 as measured by the SCL-90-R GSI. Between Years 3 and 6, the CP group continued to show improvements in psychosocial functioning as demonstrated by improvements in GAF and WSAS scores. The OIP group’s scores worsened during this time. Compared to the OIP group, participants in the CP group also had significantly better outcomes on the SIPP-118 domains of self-control and identity integration.
- There were no significant differences between groups on the proportion of participants who engaged in self-harm or experienced suicidal thoughts or attempts. There were no significant differences in outcomes between the treatment groups on the CIP, BDI, or QOL.
- Participants in CP group tended to use fewer psychotropic medications than those in the OIP group over time, but this difference was not statistically significant. The 2 groups did not differ in use of health care services over the last year.
- Avoidant personality disorder (AVPD) did not have a significant moderator effect on GAF score. Comorbid AVPD was a negative predictor of GAF score, independent of the group.
Conclusions/limitations
- Both groups experienced a remission rate of 90% at 6-year follow-up. Compared with the OIP group, participants in the CP group experienced significantly greater reductions in symptom distress and improvements in self-control and identity integration at 6 years. Between Years 3 and 6, participants in the CP group experienced significant improvements in psychosocial functioning compared with OIP group participants. The 2 groups did not differ on other outcomes, including the CIP, BDI, QOL, suicidal thoughts, suicidal attempts, self-harm, and health care utilization.
- Despite statistically significant differences in GAF scores favoring the CP group over the OIP group during Years 3 to 6, GAF scores did not differ significantly in the final year, which suggests that symptomatic remission does not equal functional improvement.
- Limitations include a lack of control for intensity or length of treatment in statistical analyses, small sample size, lack of correction for multiple testing, lack of an a priori power analysis, missing data and potential violation of the missing at random assumption, use of therapists’ preferred treatment method/practice, and a lack of control for other treatments.
5. Bateman A, Constantinou MP, Fonagy P, et al. Eight-year prospective follow-up of mentalization-based treatment versus structured clinical management for people with borderline personality disorder. Personal Disord. 2021;12(4):291-299.
The efficacy of various psychotherapies for symptoms of BPD has been well established. However, there is limited evidence that these effects persist over time. In 2009, Bateman et al13 conducted an 18-month RCT comparing the effectiveness of outpatient mentalization-based treatment (MBT) against structured clinical management (SCM) for patients with BPD. Both groups experienced substantial improvements, but patients assigned to MBT demonstrated greater improvement in clinically significant problems, including suicide attempts and hospitalizations. In a 2021 follow-up to this study, Bateman et al8 investigated whether the MBT group’s gains in the primary outcomes (absence of severe self-harm, suicide attempts, and inpatient admissions in the previous 12 months), social functioning, vocational engagement, and mental health service usage were maintained throughout an 8-year follow-up period.
Continue to: Study design...
Study design
- In the 2009 trial, Bateman et al13 randomized adult participants who met DSM-IV criteria for BPD and had a suicide attempt or episode of life-threatening self-harm in the past 6 months to receive 18 months of MBT or SCM. The primary outcome was crisis events, defined as a composite of suicidal and severe self-injurious behaviors and hospitalizations. The 2021 Bateman et al8 study expanded this investigation by collecting additional data on a yearly basis for 8 years.
- Of the 134 original participants, 98 agreed to complete the follow-up. Due to attrition, the follow-up period was limited to 8 years. At each yearly visit, researchers collected information on the primary outcome, the absence of severe self-harm, suicide attempts, and inpatient admissions in the previous 12 months.
- Secondary measures were collected mainly through a modified version of the Client Service Receipt Inventory and included critical incidents, psychiatric and medical hospital and community services, employment and other personally meaningful activity, psychoactive medication, and other mental health treatments.
Outcomes
- The number of participants who met diagnostic criteria for BPD at the 1-year follow-up was significantly lower in the MBT group compared with the SCM group. To improve participant retention, this outcome was not evaluated at later visits.
- The number of participants who achieved the primary recovery criteria of the original trial (absence of severe self-harm, suicide attempts, and inpatient admissions in the previous 12 months) and remained well throughout the entire follow-up period was significantly higher in the MBT group compared with the SCM group. The average number of years during which participants failed to meet recovery criteria was significantly greater in the SCM group compared with the MBT group.
- When controlling for age, treatment group was a significant predictor of recovery during the follow-up period. Overall, significantly fewer participants in the MBT group experienced critical incidents during the follow-up period.
- The SCM group used crisis mental health services for a significantly greater number of follow-up years than the MBT group, although the likelihood of ever using crisis services did not statistically differ between the groups. Both groups had similar use of outpatient mental health services, primary care services, and nonmental health medical services. Compared to the SCM group, the MBT group had significantly fewer professional support service visits and significantly fewer outpatient psychiatrist visits.
- MBT group participants spent more time in education, were less likely to be unemployed, and were less likely to use social care interventions than SCM group participants. Although those in the MBT group spent more months engaged in purposeful activity, there was no significant difference between the groups in the proportion of participants who did not engage in purposeful activity.
- The MBT group spent fewer months receiving psychotherapeutic medication compared with the SCM group. The variables that yielded significant 2-way interactions were eating disorder, substance use disorder, and physical abuse, suggesting greater benefit from MBT with these concurrent diagnoses. Younger age was associated with better outcomes.
Conclusions/limitations
- This study demonstrated that patients with BPD significantly benefited from specialized therapies such as MBT.
- At the 1 follow-up visit, the number of participants who met diagnostic criteria for BPD was significantly lower in the MBT group compared with the SCM group.
- The number of participants who had achieved the primary recovery criteria and remained well during the 8-year follow-up period was significantly higher in the MBT group compared to the SCM group.
- Limitations include increasing attrition over time, possible allegiance effects and unmasking of research assistants, lack of self-report questionnaires, and the potentially erroneous conclusion that increased use of services equates to poorer treatment response and greater need for support.
6. Klein JP, Hauer-von Mauschwitz A, Berger T, et al. Effectiveness and safety of the adjunctive use of an internet-based self-management intervention for borderline personality disorder in addition to care as usual: results from a randomised controlled trial. BMJ Open. 2021;11(9):e047771.
Fewer than 1 in 4 patients with BPD have access to effective psychotherapies. The use of internet-based self-management interventions (SMIs) developed from evidence-based psychotherapies can help close this treatment gap. Although the efficacy of SMIs for several mental disorders has been demonstrated in multiple meta-analyses, results for BPD are mixed. In this study, Klein et al9 examined the effectiveness and safety of the adjunctive use of an SMI based on schema therapy in addition to care as usual (CAU) in patients with BPD.
Study design
- In a 12-month, rater-blind, controlled parallel group trial, adults who had a total BPDSI score ≥15 and either a diagnosis of BPD according to DSM-IV criteria or a probable diagnosis of BPD (if they had also received a BPD diagnosis from their treating physician) were randomized to an internet-based SMI based on schema therapy called priovi (n = 103) or CAU (n = 101). Participants could complete the SMI content in approximately 6 months but were recommended to use the intervention for the entire year.
- Participation in psychotherapy and psychiatric treatment, including pharmacotherapy, was permitted. At baseline, 74% of participants were receiving psychotherapy and 88% were receiving psychiatric treatment.
- The primary outcome was change in BPDSI score at 12 months. The primary safety outcome was the number of serious adverse events at 12 months. Secondary outcomes included BPD severity, depressive symptoms, anxiety symptoms, quality of life, uncontrolled internet use, negative treatment effects, and satisfaction with the intervention. Most assessments were measured at baseline, 3 months, 6 months, 9 months, and 12 months.
Outcomes
- Large reductions in the severity of BPD symptoms as measured by change in BPDSI score was observed in both groups. Although the average reduction in BPDSI score was greater in the SMI group, this difference was not statistically significant from the CAU group.
- There was no statistically significant difference in the number of serious adverse events between groups at any time.
Conclusions/limitations
- Treatment with SMI did not result in improved outcomes over CAU. Although the average reduction in BPDSI score was greater in the SMI group compared to the CAU group, this difference was not statistically significant.
- The authors cautioned that the smaller-than-expected between-groups effect size must be interpreted against the background of an unexpectedly large effect in the CAU group. In fact, the CAU group pre/post effect was comparable to the pre/post effect of intensive specialized DBT treatment groups in previous RCTs.
- The authors also suggested that the high percentage of participants who received psychotherapy did not allow for an additional benefit from SMI.
- Limitations include recruitment method, lack of systematic assessment of accidental unblinding, high exclusion rate due to failure of the participant or treating clinician to provide confirmation of diagnosis, and the use of a serious adverse events assessment that is not psychometrically validated.
Bottom Line
Evidence from randomized controlled trials suggests that internet-based psychoeducation, brief dialectical behavior therapy skills-only treatment, interpersonal therapy, a program that combines day treatment with individual and group psychotherapy, and mentalization-based treatment can improve symptoms and quality of life for patients with borderline personality disorder.
SECOND OF 2 PARTS
Borderline personality disorder (BPD) is associated with serious impairment in psychosocial functioning.1 It is characterized by an ongoing pattern of mood instability, cognitive distortions, problems with self-image, and impulsive behavior that often results in problems in relationships. As a result, patients with BPD tend to utilize more mental health services than patients with other personality disorders or major depressive disorder.2
Some clinicians believe BPD is difficult to treat. While historically there has been little consensus on the best treatments for this disorder, current options include both pharmacologic and psychological interventions. In Part 1 of this 2-part article, we focused on 6 studies that evaluated biological interventions.3 Here in Part 2, we focus on findings from 6 recent randomized controlled trials (RCTs) of psychosocial interventions for BPD
1. Zanarini MC, Conkey LC, Temes CM, et al. Randomized controlled trial of web-based psychoeducation for women with borderline personality disorder. J Clin Psychiatry. 2018;79(3):16m11153. doi: 10.4088/JCP.16m11153
Research has shown that BPD is a treatable illness with a more favorable prognosis than previously believed. Despite this, patients often experience difficulty accessing the most up-to-date information on BPD, which can impede their treatment. A 2008 study by Zanarini et al10 of younger female patients with BPD demonstrated that immediate, in-person psychoeducation improved impulsivity and relationships. Widespread implementation of this program proved problematic, however, due to cost and personnel constraints. To resolve this issue, researchers developed an internet-based version of the program. In a 2018 follow-up study, Zanarini et al4 examined the effect of this internet-based psychoeducation program on symptoms of BPD.
Continue to: Study design...
Study design
- Women (age 18 to 30) who met DSM-IV and Diagnostic Interview for Borderlines–Revised criteria for BPD were randomized to an internet-based psychoeducation treatment group (n = 40) or a control group (n = 40).
- Ten outcomes concerning symptom severity and psychosocial functioning were assessed during weeks 1 to 12 (acute phase) and at months 6, 9, and 12 (maintenance phase) using the self-report version of the Zanarini Rating Scale for BPD (ZAN-BPD), the Borderline Evaluation of Severity over Time, the Sheehan Disability Scale, the Clinically Useful Depression Outcome Scale, the Clinically Useful Anxiety Outcome Scale, and Weissman’s Social Adjustment Scale (SAS).
Outcomes
- In the acute phase, treatment group participants experienced statistically significant improvements in all 10 outcomes. Control group participants demonstrated similar results, achieving statistically significant improvements in 7 of 10 outcomes.
- Compared to the control group, the treatment group experienced a more significant reduction in impulsivity and improvement in psychosocial functioning as measured by the ZAN-BPD and SAS.
- In the maintenance phase, treatment group participants achieved statistically significant improvements in 9 of 10 outcomes, whereas control group participants demonstrated statistically significant improvements in only 3 of 10 outcomes.
- Compared to the control group, the treatment group also demonstrated a significantly greater improvement in all 4 sector scores and the total score of the ZAN-BP
Conclusions/limitations
- In patients with BPD, internet-based psychoeducation reduced symptom severity and improved psychosocial functioning, with effects lasting 1 year. Treatment group participants experienced clinically significant improvements in all outcomes measured during the acute phase of the study; most improvements were maintained over 1 year.
- While the control group initially saw similar improvements in most measurements, these improvements were not maintained as effectively over 1 year.
- Limitations include a female-only population, the restricted age range of participants, and recruitment exclusively from volunteers.
2. McMain SF, Guimond T, Barnhart R, et al. A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. Acta Psychiatr Scand. 2017;135(2):138-148.
Standard dialectical behavior therapy (DBT) is an effective treatment for BPD; however, access is often limited by shortages of clinicians and resources. Therefore, it has become increasingly common for clinical settings to offer patients only the skills training component of DBT, which requires fewer resources. While several clinical trials examining brief DBT skills–only treatment for BPD have shown promising results, it is unclear how effective this intervention is at reducing suicidal or nonsuicidal self-injury (NSSI) episodes. McMain et al5 explored the effectiveness of brief DBT skills–only adjunctive treatment on the rates of suicidal and NSSI episodes in patients with BPD.
Study design
- In this 2-arm, single-blind, prospective controlled trial, 84 adults who met DSM-IV criteria for BPD were randomized to a 20-week DBT skills training group (DBT group) or an active waitlist (WL group). No restrictions on additional psychosocial or pharmacologic treatments were imposed on either group.
- The primary outcome was the frequency of suicidal and NSSI episodes as measured by the Lifetime Suicide Attempt Self-Injury Interview and the Deliberate Self-Harm Inventory (DSHI). Measurements occurred at baseline, 10 weeks, 20 weeks, and 3 months posttreatment (32 weeks).
- Secondary outcomes included changes in health care utilization, BPD symptoms, and coping. These were assessed using the Treatment History Interview-2, Borderline Symptom List-23, State-Trait Anger Expression Inventory, Symptom Checklist-90-revised (SCL-90-R), Barratt Impulsiveness Scale-11, Beck Depression Inventory (BDI)-II, Social Adjustment Scale Self-report, Difficulties in Emotion Regulation Scale, Distress Tolerance Scale, and Kentucky Inventory of Mindfulness Scale.
Outcomes
- At Week 32, compared to the WL group, the DBT group showed statistically significant greater reductions in the frequency of suicidal and NSSI episodes as measured by the LSASI but not by the DSHI. The DBT group experienced statistically significant improvements in distress tolerance and emotion regulation over the WL group at all points, but no difference on mindfulness. The DBT group achieved greater reductions in anger over time as compared to the WL group.
- At Week 20, compared to the WL group, the DBT group showed significant improvements in social adjustment, symptom distress, and borderline symptoms. There were no significant group differences on impulsivity. Between-group differences in the number of hospital admissions favored the DBT group at 10 and 20 weeks, but not at 32 weeks. There was no statistically significant difference between the groups with respect to the number of emergency department visits.
- Analyses of group differences in clinical improvement as measured by the SCL-90-R revealed statistically reliable and clinically significant changes in the DBT group over the WL group at 20 weeks, but not at 32 weeks.
Conclusions/limitations
- Brief DBT skills training reduced suicidal and NSSI episodes in patients with BPD. Participants in the DBT group also demonstrated greater improvement in anger, distress tolerance, and emotion regulation compared to the control group. These results were evident 3 months after treatment. However, any gains in health care utilization, social adjustment, symptom distress, and borderline symptoms diminished or did not differ from waitlist participants at Week 32. At that time, participants in the DBT group demonstrated a similar level of symptomatology as the WL group.
- Limitations include the use of an active waitlist control group, allowance of concurrent treatments, the absence of an active therapeutic comparator group, use of self-report measures, use of an instrument with unknown psychometric properties, and a relatively short 3-month follow-up period.
3. Bozzatello P, Bellino S. Combined therapy with interpersonal psychotherapy adapted for borderline personality disorder: a two-years follow-up. Psychiatry Res. 2016;240:151-156.
Psychotherapeutic options for treating BPD include DBT, mentalization-based treatment, schema-focused therapy, transference-based psychotherapy, and systems training for emotional predictability and problem solving. More recently, interpersonal therapy also has been adapted for BPD (IPT-BPD). However, thus far no trials have investigated the long-term effects of this therapy on BPD. In 2010, Bellino et al11 published a 32-week RCT examining the effect of IPT-BPD on BPD. They concluded that IPT-BPD plus fluoxetine was superior to fluoxetine alone in improving symptoms and quality of life. The present study by Bozzatello et al6 examined whether the benefits of IPT-BPD plus fluoxetine demonstrated in the 2010 study persisted over a 24-month follow-up.
Continue to: Study design...
Study design
- In the 2010 study by Bellino et al,11 55 outpatients who met DSM-IV criteria for BPD were randomized to receive IPT-BPD plus fluoxetine (combined therapy) or fluoxetine alone for 32 weeks. Forty-four participants completed a 24-month follow-up study (n = 22 for IPT-BPD plus fluoxetine, n = 22 for fluoxetine only).
- Clinical assessments were performed at 6, 12, and 24 months, and used the same instruments as the original study, including the Clinical Global Impression Scale–Severity item, Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale (HARS), Social and Occupational Functioning Assessment, Satisfaction Profile (SAT-P), and the Borderline Personality Disorder Severity Index (BPDSI).
Outcomes
- While the original study demonstrated that combined therapy had a clinically significant effect over fluoxetine alone on both HARS score and the BPDSI item “affective instability” at 32 weeks, this advantage was maintained only at the 6-month assessment.
- The improvements that the combined therapy provided over fluoxetine monotherapy on the BPDSI items of “impulsivity” and “interpersonal relationships” as well as the SAT-P factors of social and psychological functioning at 32 weeks were preserved at 24 months. No additional improvements were seen.
Conclusions/limitations
- The improvements in impulsivity, interpersonal functioning, social functioning, and psychological functioning at 32 weeks seen with IPT-BPD plus fluoxetine compared with fluoxetine alone persisted for 2 years after completing therapy; no further improvements were seen.
- The improvements to anxiety and affective instability that combined therapy demonstrated over fluoxetine monotherapy at 32 weeks were not maintained at 24 months.
- Limitations include a small sample size, exclusion of psychiatric comorbidities, and a lack of assessment of session or medication adherence.
4. Antonsen BT, Kvarstein EH, Urnes Ø, et al. Favourable outcome of long-term combined psychotherapy for patients with borderline personality disorder: six-year follow-up of a randomized study. Psychother Res. 2017;27(1):51-63.
While many studies have demonstrated the benefits of psychotherapy for treating personality disorders, there is limited research of how different levels of psychotherapy may impact treatment outcomes. An RCT called the Ullevål Personality Project (UPP)12 compared an intensive combined treatment program (CP) with outpatient individual psychotherapy (OIP) in patients with personality disorders. The CP program consisted of short-term day-hospital treatment followed by outpatient combined group and individual psychotherapy. The outcomes this RCT evaluated included suicide attempts, suicidal thoughts, self-injury, psychosocial functioning, symptom distress, and interpersonal and personality problems. A 6-year follow-up concluded there were no differences in outcomes between the 2 treatment groups. However, in this RCT, Antonsen et al7 examined whether CP produced statistically significant benefits over OIP in a subset of patients with BPD.
Study design
- In the UPP trial,12 117 patients who met DSM-IV criteria for personality disorders (excluding antisocial and schizotypal personality disorder) were randomized to receive 18 weeks of day hospital psychotherapy followed by CP or OIP. Fifty-two participants in the UPP were diagnosed with BPD, and 34 of these participants completed the 6-year follow-up investigation.
- Symptom distress, psychosocial functioning, interpersonal problems, quality of life, personality functioning, and self-harm/suicidal thoughts/suicide attempts were assessed at baseline, 8 months, 18 months, 3 years, and 6 years using the SCL-90-R Global Severity Index (GSI), BDI, Global Assessment of Functioning (GAF), Work and Social Adjustment Scale (WSAS), Quality of Life 10-point scale (QOL), Circumplex of Interpersonal Problems (CIP), and the 60-item short form of the Severity Indices of Personality Problems (SIPP-118) questionnaire.
Outcomes
- Compared to the OIP group, the CP group demonstrated statistically significant reductions in symptom distress at Year 6 as measured by the SCL-90-R GSI. Between Years 3 and 6, the CP group continued to show improvements in psychosocial functioning as demonstrated by improvements in GAF and WSAS scores. The OIP group’s scores worsened during this time. Compared to the OIP group, participants in the CP group also had significantly better outcomes on the SIPP-118 domains of self-control and identity integration.
- There were no significant differences between groups on the proportion of participants who engaged in self-harm or experienced suicidal thoughts or attempts. There were no significant differences in outcomes between the treatment groups on the CIP, BDI, or QOL.
- Participants in CP group tended to use fewer psychotropic medications than those in the OIP group over time, but this difference was not statistically significant. The 2 groups did not differ in use of health care services over the last year.
- Avoidant personality disorder (AVPD) did not have a significant moderator effect on GAF score. Comorbid AVPD was a negative predictor of GAF score, independent of the group.
Conclusions/limitations
- Both groups experienced a remission rate of 90% at 6-year follow-up. Compared with the OIP group, participants in the CP group experienced significantly greater reductions in symptom distress and improvements in self-control and identity integration at 6 years. Between Years 3 and 6, participants in the CP group experienced significant improvements in psychosocial functioning compared with OIP group participants. The 2 groups did not differ on other outcomes, including the CIP, BDI, QOL, suicidal thoughts, suicidal attempts, self-harm, and health care utilization.
- Despite statistically significant differences in GAF scores favoring the CP group over the OIP group during Years 3 to 6, GAF scores did not differ significantly in the final year, which suggests that symptomatic remission does not equal functional improvement.
- Limitations include a lack of control for intensity or length of treatment in statistical analyses, small sample size, lack of correction for multiple testing, lack of an a priori power analysis, missing data and potential violation of the missing at random assumption, use of therapists’ preferred treatment method/practice, and a lack of control for other treatments.
5. Bateman A, Constantinou MP, Fonagy P, et al. Eight-year prospective follow-up of mentalization-based treatment versus structured clinical management for people with borderline personality disorder. Personal Disord. 2021;12(4):291-299.
The efficacy of various psychotherapies for symptoms of BPD has been well established. However, there is limited evidence that these effects persist over time. In 2009, Bateman et al13 conducted an 18-month RCT comparing the effectiveness of outpatient mentalization-based treatment (MBT) against structured clinical management (SCM) for patients with BPD. Both groups experienced substantial improvements, but patients assigned to MBT demonstrated greater improvement in clinically significant problems, including suicide attempts and hospitalizations. In a 2021 follow-up to this study, Bateman et al8 investigated whether the MBT group’s gains in the primary outcomes (absence of severe self-harm, suicide attempts, and inpatient admissions in the previous 12 months), social functioning, vocational engagement, and mental health service usage were maintained throughout an 8-year follow-up period.
Continue to: Study design...
Study design
- In the 2009 trial, Bateman et al13 randomized adult participants who met DSM-IV criteria for BPD and had a suicide attempt or episode of life-threatening self-harm in the past 6 months to receive 18 months of MBT or SCM. The primary outcome was crisis events, defined as a composite of suicidal and severe self-injurious behaviors and hospitalizations. The 2021 Bateman et al8 study expanded this investigation by collecting additional data on a yearly basis for 8 years.
- Of the 134 original participants, 98 agreed to complete the follow-up. Due to attrition, the follow-up period was limited to 8 years. At each yearly visit, researchers collected information on the primary outcome, the absence of severe self-harm, suicide attempts, and inpatient admissions in the previous 12 months.
- Secondary measures were collected mainly through a modified version of the Client Service Receipt Inventory and included critical incidents, psychiatric and medical hospital and community services, employment and other personally meaningful activity, psychoactive medication, and other mental health treatments.
Outcomes
- The number of participants who met diagnostic criteria for BPD at the 1-year follow-up was significantly lower in the MBT group compared with the SCM group. To improve participant retention, this outcome was not evaluated at later visits.
- The number of participants who achieved the primary recovery criteria of the original trial (absence of severe self-harm, suicide attempts, and inpatient admissions in the previous 12 months) and remained well throughout the entire follow-up period was significantly higher in the MBT group compared with the SCM group. The average number of years during which participants failed to meet recovery criteria was significantly greater in the SCM group compared with the MBT group.
- When controlling for age, treatment group was a significant predictor of recovery during the follow-up period. Overall, significantly fewer participants in the MBT group experienced critical incidents during the follow-up period.
- The SCM group used crisis mental health services for a significantly greater number of follow-up years than the MBT group, although the likelihood of ever using crisis services did not statistically differ between the groups. Both groups had similar use of outpatient mental health services, primary care services, and nonmental health medical services. Compared to the SCM group, the MBT group had significantly fewer professional support service visits and significantly fewer outpatient psychiatrist visits.
- MBT group participants spent more time in education, were less likely to be unemployed, and were less likely to use social care interventions than SCM group participants. Although those in the MBT group spent more months engaged in purposeful activity, there was no significant difference between the groups in the proportion of participants who did not engage in purposeful activity.
- The MBT group spent fewer months receiving psychotherapeutic medication compared with the SCM group. The variables that yielded significant 2-way interactions were eating disorder, substance use disorder, and physical abuse, suggesting greater benefit from MBT with these concurrent diagnoses. Younger age was associated with better outcomes.
Conclusions/limitations
- This study demonstrated that patients with BPD significantly benefited from specialized therapies such as MBT.
- At the 1 follow-up visit, the number of participants who met diagnostic criteria for BPD was significantly lower in the MBT group compared with the SCM group.
- The number of participants who had achieved the primary recovery criteria and remained well during the 8-year follow-up period was significantly higher in the MBT group compared to the SCM group.
- Limitations include increasing attrition over time, possible allegiance effects and unmasking of research assistants, lack of self-report questionnaires, and the potentially erroneous conclusion that increased use of services equates to poorer treatment response and greater need for support.
6. Klein JP, Hauer-von Mauschwitz A, Berger T, et al. Effectiveness and safety of the adjunctive use of an internet-based self-management intervention for borderline personality disorder in addition to care as usual: results from a randomised controlled trial. BMJ Open. 2021;11(9):e047771.
Fewer than 1 in 4 patients with BPD have access to effective psychotherapies. The use of internet-based self-management interventions (SMIs) developed from evidence-based psychotherapies can help close this treatment gap. Although the efficacy of SMIs for several mental disorders has been demonstrated in multiple meta-analyses, results for BPD are mixed. In this study, Klein et al9 examined the effectiveness and safety of the adjunctive use of an SMI based on schema therapy in addition to care as usual (CAU) in patients with BPD.
Study design
- In a 12-month, rater-blind, controlled parallel group trial, adults who had a total BPDSI score ≥15 and either a diagnosis of BPD according to DSM-IV criteria or a probable diagnosis of BPD (if they had also received a BPD diagnosis from their treating physician) were randomized to an internet-based SMI based on schema therapy called priovi (n = 103) or CAU (n = 101). Participants could complete the SMI content in approximately 6 months but were recommended to use the intervention for the entire year.
- Participation in psychotherapy and psychiatric treatment, including pharmacotherapy, was permitted. At baseline, 74% of participants were receiving psychotherapy and 88% were receiving psychiatric treatment.
- The primary outcome was change in BPDSI score at 12 months. The primary safety outcome was the number of serious adverse events at 12 months. Secondary outcomes included BPD severity, depressive symptoms, anxiety symptoms, quality of life, uncontrolled internet use, negative treatment effects, and satisfaction with the intervention. Most assessments were measured at baseline, 3 months, 6 months, 9 months, and 12 months.
Outcomes
- Large reductions in the severity of BPD symptoms as measured by change in BPDSI score was observed in both groups. Although the average reduction in BPDSI score was greater in the SMI group, this difference was not statistically significant from the CAU group.
- There was no statistically significant difference in the number of serious adverse events between groups at any time.
Conclusions/limitations
- Treatment with SMI did not result in improved outcomes over CAU. Although the average reduction in BPDSI score was greater in the SMI group compared to the CAU group, this difference was not statistically significant.
- The authors cautioned that the smaller-than-expected between-groups effect size must be interpreted against the background of an unexpectedly large effect in the CAU group. In fact, the CAU group pre/post effect was comparable to the pre/post effect of intensive specialized DBT treatment groups in previous RCTs.
- The authors also suggested that the high percentage of participants who received psychotherapy did not allow for an additional benefit from SMI.
- Limitations include recruitment method, lack of systematic assessment of accidental unblinding, high exclusion rate due to failure of the participant or treating clinician to provide confirmation of diagnosis, and the use of a serious adverse events assessment that is not psychometrically validated.
Bottom Line
Evidence from randomized controlled trials suggests that internet-based psychoeducation, brief dialectical behavior therapy skills-only treatment, interpersonal therapy, a program that combines day treatment with individual and group psychotherapy, and mentalization-based treatment can improve symptoms and quality of life for patients with borderline personality disorder.
1. Skodol AE, Gunderson JG, McGlashan TM, et al. Functional impairment in patients with schizotypal, borderline, avoidant, or obsessive-compulsive personality disorder. Am J Psychiatry. 2002;159(2):276-83.
2. Bender DS, Dolan RT, Skodol AE, et al. Treatment utilization by patients with personality disorders. Am J Psychiatry. 2001;158(2):295-302.
3. Saeed SA, Kallis AC. Borderline personality disorder: 6 studies of biological interventions. Current Psychiatry. 2021;20(11):26-30,34-36.
4. Zanarini MC, Conkey LC, Temes CM, et al. Randomized controlled trial of web-based psychoeducation for women with borderline personality disorder. J Clin Psychiatry. 2018;79(3):16m11153. doi:10.4088/JCP.16m11153
5. McMain SF, Guimond T, Barnhart R, et al. A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. Acta Psychiatr Scand. 2017;135(2):138-148. doi:10.1111/acps.12664
6. Bozzatello P, Bellino S. Combined therapy with interpersonal psychotherapy adapted for borderline personality disorder: a two-years follow-up. Psychiatry Res. 2016;240:151-156. doi:10.1016/j.psychres.2016.04.014
7. Antonsen BT, Kvarstein EH, Urnes Ø, et al. Favourable outcome of long-term combined psychotherapy for patients with borderline personality disorder: six-year follow-up of a randomized study. Psychother Res. 2017;27(1):51-63. doi:10.1080/10503307.2015.1072283
8. Bateman A, Constantinou MP, Fonagy P, et al. Eight-year prospective follow-up of mentalization-based treatment versus structured clinical management for people with borderline personality disorder. Personal Disord. 2021;12(4):291-299. doi:10.1037/per0000422
9. Klein JP, Hauer-von Mauschwitz A, Berger T, et al. Effectiveness and safety of the adjunctive use of an internet-based self-management intervention for borderline personality disorder in addition to care as usual: results from a randomised controlled trial. BMJ Open. 2021;11(9):e047771. doi:10.1136/bmjopen-2020-047771
10. Zanarini MC, Frankenburg FR. A preliminary, randomized trial of psychoeducation for women with borderline personality disorder. J Pers Disord. 2008;22(3):284-290.
11. Bellino S, Rinaldi C, Bogetto F. Adaptation of interpersonal psychotherapy to borderline personality disorder: a comparison of combined therapy and single pharmacotherapy. Can J Psychiatry. 2010;55(2):74-81.
12. Arnevik E, Wilberg T, Urnes Ø, et al. Psychotherapy for personality disorders: short-term day hospital psychotherapy versus outpatient individual therapy – a randomized controlled study. Eur Psychiatry. 2009,24(2):71-78. doi:10.1016/j.eurpsy.2008.09.004
13. Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009;166(12):1355-1364.
1. Skodol AE, Gunderson JG, McGlashan TM, et al. Functional impairment in patients with schizotypal, borderline, avoidant, or obsessive-compulsive personality disorder. Am J Psychiatry. 2002;159(2):276-83.
2. Bender DS, Dolan RT, Skodol AE, et al. Treatment utilization by patients with personality disorders. Am J Psychiatry. 2001;158(2):295-302.
3. Saeed SA, Kallis AC. Borderline personality disorder: 6 studies of biological interventions. Current Psychiatry. 2021;20(11):26-30,34-36.
4. Zanarini MC, Conkey LC, Temes CM, et al. Randomized controlled trial of web-based psychoeducation for women with borderline personality disorder. J Clin Psychiatry. 2018;79(3):16m11153. doi:10.4088/JCP.16m11153
5. McMain SF, Guimond T, Barnhart R, et al. A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. Acta Psychiatr Scand. 2017;135(2):138-148. doi:10.1111/acps.12664
6. Bozzatello P, Bellino S. Combined therapy with interpersonal psychotherapy adapted for borderline personality disorder: a two-years follow-up. Psychiatry Res. 2016;240:151-156. doi:10.1016/j.psychres.2016.04.014
7. Antonsen BT, Kvarstein EH, Urnes Ø, et al. Favourable outcome of long-term combined psychotherapy for patients with borderline personality disorder: six-year follow-up of a randomized study. Psychother Res. 2017;27(1):51-63. doi:10.1080/10503307.2015.1072283
8. Bateman A, Constantinou MP, Fonagy P, et al. Eight-year prospective follow-up of mentalization-based treatment versus structured clinical management for people with borderline personality disorder. Personal Disord. 2021;12(4):291-299. doi:10.1037/per0000422
9. Klein JP, Hauer-von Mauschwitz A, Berger T, et al. Effectiveness and safety of the adjunctive use of an internet-based self-management intervention for borderline personality disorder in addition to care as usual: results from a randomised controlled trial. BMJ Open. 2021;11(9):e047771. doi:10.1136/bmjopen-2020-047771
10. Zanarini MC, Frankenburg FR. A preliminary, randomized trial of psychoeducation for women with borderline personality disorder. J Pers Disord. 2008;22(3):284-290.
11. Bellino S, Rinaldi C, Bogetto F. Adaptation of interpersonal psychotherapy to borderline personality disorder: a comparison of combined therapy and single pharmacotherapy. Can J Psychiatry. 2010;55(2):74-81.
12. Arnevik E, Wilberg T, Urnes Ø, et al. Psychotherapy for personality disorders: short-term day hospital psychotherapy versus outpatient individual therapy – a randomized controlled study. Eur Psychiatry. 2009,24(2):71-78. doi:10.1016/j.eurpsy.2008.09.004
13. Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009;166(12):1355-1364.
Psychiatric partial hospitalization programs: What you need to know
Psychiatric partial hospitalization programs (PHPs), previously known as “day hospitals,” serve to bridge the gap between inpatient and outpatient facilities by providing intensive, highly structured outpatient behavioral health services (typically several hours of psychotherapy each weekday for most days of the week). The concept of PHPs has existed since at least the 1950s, but such programs started to become more common in the United States as the result of legislation passed in 1963 (Box1-3). In this article, I provide a brief introductory review of PHPs, while acknowledging that most research on PHPs was conducted years ago and is rather limited.
Box
The concept of partial hospitalization programs (PHPs) was developed before the 1950s.1 However, in the United States, PHPs did not take hold until Congress passed the Community Mental Health Act of 1963, which required that PHPs must be a core component of Community Mental Health Centers (CMHCs). The Omnibus Budget Reconciliation Acts of 1987 and 1990 required Medicare to pay for PHPs affiliated with or based in CMHCs and psychiatric hospitals, which resulted in a proliferation of PHPs across the country. The number of CMHCbased PHPs grew from 296 in 1993 to 769 in 1997.2 By 2016, more than one-third (38.7%) of all metropolitan hospitals and 11.4% of nonmetropolitan hospitals in the United States provided PHP services.3 This growth was also partially the result of private health insurance companies and the managed care industry clamping down on inpatient hospital stays and approving PHP care to reduce costs. In recent years, freestanding PHPs that are not affiliated with a CMHC or hospital have opened to serve high-functioning patients who do not want inpatient hospitalization or the stigma associated with it.
PHPs: What they are, and how they work
The term “partial hospitalization” is fraught with confusion because initially it was used to contrast such services from full hospitalization. Historically, it was used to describe services for patients who had been discharged home from a state hospital and attended a program on the hospital grounds during the day as outpatients. In reality, today’s PHPs are “day treatment” programs, but the terminology has stuck.
PHPs are neither an inpatient service nor a strict outpatient service, but rather a midground along the continuum of treatment intensity between the 2 traditional types of psychiatric services for patients with a range of mental illness of varying severity. The Association for Ambulatory Behavioral Healthcare, which has set standards and guidelines for PHPs, defines a PHP as “an ambulatory treatment program that includes the major diagnostic, medical, psychiatric, psychosocial, and prevocational treatment modalities designed for patients with serious mental disorders who require coordinated intensive, comprehensive, and multidisciplinary treatment not provided in an outpatient clinical setting.”4 PHPs can render acute care as an alternative to inpatient treatment, provide transitional stabilization treatment between an inpatient stay and traditional outpatient treatment (once a week or less frequent), and function as a supplement to traditional outpatient treatment.
Medicare has established criteria that PHPs must meet to qualify for reimbursement5; these criteria are now widely accepted as standards of care by the insurance industry. To meet the Medicare criteria, PHP treatment must be active and structured to provide an individualized treatment plan that incorporates coordination of services to meet the particular needs of the patient.5 It must include a multidisciplinary team approach to patient care under the direction of a physician, and the treatment goals must be measurable, functional, time-framed, medically necessary, and directly related to the reason for admission.5 The physician must certify the medical necessity for admission by documenting that the patient has a diagnosis of an acute Axis I mental disorder, a level of functioning that includes severe impairments in multiple areas of daily life, and a “reasonable expectation” that the disorder and level of functioning will improve as a result of the treatment.5
The Joint Commission (formerly JCAHO) lumps day treatment, intensive outpatient, partial hospitalization, and adult day care services into a single category of an ambulatory health care environment offering an organized day or night program of assessment, treatment, care, services, habilitation, or rehabilitation for individuals who do not require 24-hour care.6 For behavioral health, this may be a structured, ongoing program that typically meets 2 to 5 times a week for 2 to 5 hours per day.6
Most PHPs for adult patients provide services during the day 5 days per week and average 5 to 6 hours of programming per day. Night or evening programming may be a good option for patients who work during the day. Typically, treatment is provided in a group therapy format, with individual therapy at least once a week. Group therapy may include cognitive-behavioral therapy, coping with grief and loss, trauma recovery, conflict resolution, stress management, anger control, and behavioral modification. Family therapy is provided as needed, but usually is mandatory for children and adolescents. Many PHPs offer intensive outpatient programs (IOPs) as a step down to further facilitate a patient’s adjustment to psychosocial and family functioning while returning to work on a part-time basis. IOPs typically provide 3 to 4 hours of service per day 3 days per week. While not evidence-based, the typical duration of PHP treatment is 4 to 6 weeks, followed by an additional 2 to 4 weeks of IOP.
Continue to: Advantages and disadvantages...
Advantages and disadvantages
Based on a qualitative literature review, Neffinger1 outlined potential advantages and disadvantages of PHPs vs inpatient hospitalization (Table1). While these have not been empirically studied, they may be useful to consider when determining if a PHP would be beneficial for a specific patient.
Which factors are most therapeutic?
Research on which factors of PHPs are of therapeutic value is quite limited and primarily consists of surveys of small numbers of participants. Hoge et al7 explored the active therapeutic factors responsible for change in the Connecticut Mental Health Center PHP by comparing responses of 20 patients with those of their clinicians. Ninety-five percent of patients rated structure as the top therapeutic factor, followed by interpersonal contact, medication, and altruism. Other factors that were rated as important by 40% or fewer participants were catharsis, learning, mobilization of family support, connection to community, universality, patient autonomy, successful completion, security, feedback on behavior, and practice at home. In a British study8 that used a similar method, patients reported that counseling was the most helpful aspect of treatment, followed by medical treatment, while staff picked groups followed by a planned approach.
Evidence supports PHPs’ effectiveness
Some research has suggested that PHPs can be effective, both clinically and in terms of cost. Marshall et al9 conducted a systematic review of the effectiveness of an acute day hospital vs inpatient admission vs outpatient care that included 9 trials. They concluded that psychiatric inpatient admissions could be reduced by at least 23% if patients were diverted to an acute day hospital. They also found some evidence that day treatment programs may be superior to outpatient care in improving symptoms in nonpsychotic patients who are refractory to outpatient treatment. In a systematic review of 18 studies, high rates of satisfaction with PHP services suggested PHPs have an advantage over inpatient treatment within 1 year of discharge; patients and families were more satisfied with PHPs.10 In a study of 197 urban, socioeconomically disadvantaged, severely ill patients, Sledge et al11 compared the clinical outcomes of those who participated in day hospital programs with those of patients who received inpatient care. They found that while overall the 2 approaches produced similar outcomes, there were slightly more positive effects for day hospital programs in measures of symptoms, overall functioning, and social functioning. In terms of cost effectiveness, a 1978 study found that even after correcting for differences in treatment days between inpatient and PHP services, there was a significant financial advantage with PHP (costs were one-third less), primarily because of lower costs per day.12 In another study, PHP cost savings were 20%, and potential savings were higher for nonpsychotic patients.13
Are PHPs appropriate for children and adolescents?
Studies of PHPs for adolescents found that patients made gains in peer relationships, behavioral and academic performance, and control of their emotions.14,15 A review of PHPs’ effectiveness for children suggested that 66% to 99% of treated patients demonstrated improvement and successful return to community-based schools, and family functioning was a major factor in improvement.14 In a follow-up study that surveyed patients via telephone >1 year after discharge from a PHP, almost 80% of the children and adolescents were either “doing OK” or were “well-adjusted.”14 Only 22.5% required inpatient or residential treatment; the majority were doing well in school, with only 7% failing.14 In addition, 60% of parents reported satisfaction with treatment, and 85% reported functional improvement in their children.
Factors that predict PHP success or failure
In an analysis of a day treatment program that provided 4 months of intensive psychodynamic, group-oriented milieu treatment for patients with long-standing personality disorders, Rosie et al16 found 3 factors that contributed to the success of the PHP:
- optimal treatment-patient matching
- judicious use of authority in milieu therapy
- maintaining close relationships with referral sources.
In a study that compared 58 patients who completed an Ottawa hospital PHP and 44 who did not complete the program, psychological mindedness and chronicity of psychiatric illness were found to predict completion.17 However, a study of 59 females with anorexia nervosa who were transferred from inpatient care to an eating disorder day hospital program found that a longer duration of illness, amenorrhea, and a lower body mass index were associated with PHP treatment failure and inpatient rehospitalization.18 One study found that for individuals who were referred to a PHP from inpatient care, suicidal ideation and greater psychotic symptoms were associated with acute inpatient rehospitalization.19 Other factors associated with PHP nonattendance and treatment failure include limited personal and economic resources, high rates of substance abuse disorders, multiple admissions, and disability.20 In a study of 103 alcohol-dependent patients who completed IOP treatment, 64% were abstinent at 6 months follow-up; relapse was associated with a longer duration of alcohol dependence and a higher number of prior treatments, while favorable outcomes were associated with a lower degree of depression, anxiety, and craving.21 Patients with cocaine dependence who completed an IOP showed significant improvements in addiction scores and had more favorable outcomes in employment status and psychological problems if they stayed longer in treatment.22
Bottom Line
Psychiatric partial hospitalization programs (PHPs) provide a transition from inpatient hospitalization to outpatient treatment for patients who need further stabilization, or serve as an alternative to inpatient treatment for patients who don’t need or want inpatient hospitalization. PHPs can be as effective as inpatient treatment for all but the most seriously ill patients, and are more cost-effective than inpatient treatment.
1. Neffinger GG. Partial hospitalization: an overview. J Community Psychol. 1981;9(3):262-269.
2. Leung MY, Drozd EM, Healy DA, et al. Impacts associated with the Medicare Psychiatric PPS: a study of partial hospitalization programs. February 2009. Accessed January 8, 2022. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Reports/downloads/Leung_PHP_PPS_2010.pdf
3. Williams T, Borders TF, Jasinski L. Partial Psychiatric Hospitalization Program Availability in Non-Metropolitan and Non-Metropolitan Hospitals Nationally. Rural and Underserved Health Research Center; 2019.
4. Rosser J, Michael S, eds. Standards and guidelines for partial hospital programs and intensive outpatient programs. Association for Ambulatory Behavioral Healthcare. 2018. Accessed January 8, 2022. https://aabh.org/wp-content/uploads/2021/05/2021-SandG-Final.pdf
5. CMS Manual System PUB. 100-02 Medicare Benefit Policy: Partial Hospitalization Services, Department of Health and Human Services. Centers for Medicare & Medicaid Services; 2004:6-9.
6. Joint Commission. Guide to Joint Commission Behavioral Healthcare Accreditation. Joint Commission; 2007:36.
7. Hoge MA, Farrell SP, Munchel ME, et al. Therapeutic factors in partial hospitalization. Psychiatry. 1988;51(2):199-210.
8. Ricketts T, Kirshbaum MN. Helpfulness of mental health day care: client and staff views. J Adv Nurs. 1994;20(2):297-306.
9. Marshall M, Crowther R, Almaraz-Serrano A, et al. Systematic reviews of the effectiveness of day care for people with severe mental disorders: (1) acute day hospital versus admission; (2) vocational rehabilitation; (3) day hospital versus outpatient care. Health Technol Assess. 2001;5(21):1-75.
10. Horvitz-Lennon M, Normand SL, Gaccione P, et al. Partial versus full hospitalization for adults in psychiatric distress: a systematic review of the published literature (1957-1997). Am J Psychiatry. 2001;158(5):676-685.
11. Sledge WH, Tebes J, Rakfeldt J, et al. Day hospital/crisis respite care versus inpatient care, Part I: Clinical outcomes. Am J Psychiatry. 1996;153(8):1065-1073.
12. Fink EB, Longabaugh R, Stout R. The paradoxical underutilization of partial hospitalization. Am J Psychiatry. 1978;135(6):713-716.
13. Sledge WH, Tebes J, Wolff N, et al. Day hospital/crisis respite care versus inpatient care, Part II: service utilization and costs. Am J Psychiatry. 1996;153(8):1074-1083.
14. Kiser LJ. Treatment-effectiveness research in child and adolescent partial hospitalization. Psychiatr Hosp. 1991;22(2):51-8.
15. Milin R, Coupland K, Walker S, et al. Outcome and follow-up study of an adolescent psychiatric day treatment school program. J Am Acad Child Adolesc Psychiatry. 2000;39(3):320-328.
16. Rosie JS, Azim HF, Piper WE, et al. Effective psychiatric day treatment: historical lessons. Psychiatr Serv. 1995;46(10):1019-1026.
17. Tasca GA, Balfour L, Bissada H, et al. Treatment completion and outcome in a partial hospitalization program: interactions among patient variables. Psychotherapy Res. 1999;9(2):232-247.
18. Howard WT, Evans KK, Quintero-Howard CV, et al. Predictors of success or failure of transition to day hospital treatment for inpatients with anorexia nervosa. Am J Psychiatry. 1999;156(11):1697-1702.
19. Beard C, Hearon BA, Lee J, et al. When partial hospitalization fails: risk factors for inpatient hospitalization. J Nerv Ment Dis. 2016;204(6):431-436.
20. Lieberman PB, Guggenheim FG. Reasons for patient nonattendance during acute partial hospitalization. Psychiatr Serv. 2016;67(6):684-687.
21. Bottlender M, Soyka M. Efficacy of an intensive outpatient rehabilitation program in alcoholism: predictors of outcome 6 months after treatment. Eur Addict Res. 2005;11(3):132-137.
22. Gottheil E, Weinstein SP, Sterling RC, et al. A randomized controlled study of the effectiveness of intensive outpatient treatment for cocaine dependence. Psychiatr Serv. 1998;49(6):782-787.
Psychiatric partial hospitalization programs (PHPs), previously known as “day hospitals,” serve to bridge the gap between inpatient and outpatient facilities by providing intensive, highly structured outpatient behavioral health services (typically several hours of psychotherapy each weekday for most days of the week). The concept of PHPs has existed since at least the 1950s, but such programs started to become more common in the United States as the result of legislation passed in 1963 (Box1-3). In this article, I provide a brief introductory review of PHPs, while acknowledging that most research on PHPs was conducted years ago and is rather limited.
Box
The concept of partial hospitalization programs (PHPs) was developed before the 1950s.1 However, in the United States, PHPs did not take hold until Congress passed the Community Mental Health Act of 1963, which required that PHPs must be a core component of Community Mental Health Centers (CMHCs). The Omnibus Budget Reconciliation Acts of 1987 and 1990 required Medicare to pay for PHPs affiliated with or based in CMHCs and psychiatric hospitals, which resulted in a proliferation of PHPs across the country. The number of CMHCbased PHPs grew from 296 in 1993 to 769 in 1997.2 By 2016, more than one-third (38.7%) of all metropolitan hospitals and 11.4% of nonmetropolitan hospitals in the United States provided PHP services.3 This growth was also partially the result of private health insurance companies and the managed care industry clamping down on inpatient hospital stays and approving PHP care to reduce costs. In recent years, freestanding PHPs that are not affiliated with a CMHC or hospital have opened to serve high-functioning patients who do not want inpatient hospitalization or the stigma associated with it.
PHPs: What they are, and how they work
The term “partial hospitalization” is fraught with confusion because initially it was used to contrast such services from full hospitalization. Historically, it was used to describe services for patients who had been discharged home from a state hospital and attended a program on the hospital grounds during the day as outpatients. In reality, today’s PHPs are “day treatment” programs, but the terminology has stuck.
PHPs are neither an inpatient service nor a strict outpatient service, but rather a midground along the continuum of treatment intensity between the 2 traditional types of psychiatric services for patients with a range of mental illness of varying severity. The Association for Ambulatory Behavioral Healthcare, which has set standards and guidelines for PHPs, defines a PHP as “an ambulatory treatment program that includes the major diagnostic, medical, psychiatric, psychosocial, and prevocational treatment modalities designed for patients with serious mental disorders who require coordinated intensive, comprehensive, and multidisciplinary treatment not provided in an outpatient clinical setting.”4 PHPs can render acute care as an alternative to inpatient treatment, provide transitional stabilization treatment between an inpatient stay and traditional outpatient treatment (once a week or less frequent), and function as a supplement to traditional outpatient treatment.
Medicare has established criteria that PHPs must meet to qualify for reimbursement5; these criteria are now widely accepted as standards of care by the insurance industry. To meet the Medicare criteria, PHP treatment must be active and structured to provide an individualized treatment plan that incorporates coordination of services to meet the particular needs of the patient.5 It must include a multidisciplinary team approach to patient care under the direction of a physician, and the treatment goals must be measurable, functional, time-framed, medically necessary, and directly related to the reason for admission.5 The physician must certify the medical necessity for admission by documenting that the patient has a diagnosis of an acute Axis I mental disorder, a level of functioning that includes severe impairments in multiple areas of daily life, and a “reasonable expectation” that the disorder and level of functioning will improve as a result of the treatment.5
The Joint Commission (formerly JCAHO) lumps day treatment, intensive outpatient, partial hospitalization, and adult day care services into a single category of an ambulatory health care environment offering an organized day or night program of assessment, treatment, care, services, habilitation, or rehabilitation for individuals who do not require 24-hour care.6 For behavioral health, this may be a structured, ongoing program that typically meets 2 to 5 times a week for 2 to 5 hours per day.6
Most PHPs for adult patients provide services during the day 5 days per week and average 5 to 6 hours of programming per day. Night or evening programming may be a good option for patients who work during the day. Typically, treatment is provided in a group therapy format, with individual therapy at least once a week. Group therapy may include cognitive-behavioral therapy, coping with grief and loss, trauma recovery, conflict resolution, stress management, anger control, and behavioral modification. Family therapy is provided as needed, but usually is mandatory for children and adolescents. Many PHPs offer intensive outpatient programs (IOPs) as a step down to further facilitate a patient’s adjustment to psychosocial and family functioning while returning to work on a part-time basis. IOPs typically provide 3 to 4 hours of service per day 3 days per week. While not evidence-based, the typical duration of PHP treatment is 4 to 6 weeks, followed by an additional 2 to 4 weeks of IOP.
Continue to: Advantages and disadvantages...
Advantages and disadvantages
Based on a qualitative literature review, Neffinger1 outlined potential advantages and disadvantages of PHPs vs inpatient hospitalization (Table1). While these have not been empirically studied, they may be useful to consider when determining if a PHP would be beneficial for a specific patient.
Which factors are most therapeutic?
Research on which factors of PHPs are of therapeutic value is quite limited and primarily consists of surveys of small numbers of participants. Hoge et al7 explored the active therapeutic factors responsible for change in the Connecticut Mental Health Center PHP by comparing responses of 20 patients with those of their clinicians. Ninety-five percent of patients rated structure as the top therapeutic factor, followed by interpersonal contact, medication, and altruism. Other factors that were rated as important by 40% or fewer participants were catharsis, learning, mobilization of family support, connection to community, universality, patient autonomy, successful completion, security, feedback on behavior, and practice at home. In a British study8 that used a similar method, patients reported that counseling was the most helpful aspect of treatment, followed by medical treatment, while staff picked groups followed by a planned approach.
Evidence supports PHPs’ effectiveness
Some research has suggested that PHPs can be effective, both clinically and in terms of cost. Marshall et al9 conducted a systematic review of the effectiveness of an acute day hospital vs inpatient admission vs outpatient care that included 9 trials. They concluded that psychiatric inpatient admissions could be reduced by at least 23% if patients were diverted to an acute day hospital. They also found some evidence that day treatment programs may be superior to outpatient care in improving symptoms in nonpsychotic patients who are refractory to outpatient treatment. In a systematic review of 18 studies, high rates of satisfaction with PHP services suggested PHPs have an advantage over inpatient treatment within 1 year of discharge; patients and families were more satisfied with PHPs.10 In a study of 197 urban, socioeconomically disadvantaged, severely ill patients, Sledge et al11 compared the clinical outcomes of those who participated in day hospital programs with those of patients who received inpatient care. They found that while overall the 2 approaches produced similar outcomes, there were slightly more positive effects for day hospital programs in measures of symptoms, overall functioning, and social functioning. In terms of cost effectiveness, a 1978 study found that even after correcting for differences in treatment days between inpatient and PHP services, there was a significant financial advantage with PHP (costs were one-third less), primarily because of lower costs per day.12 In another study, PHP cost savings were 20%, and potential savings were higher for nonpsychotic patients.13
Are PHPs appropriate for children and adolescents?
Studies of PHPs for adolescents found that patients made gains in peer relationships, behavioral and academic performance, and control of their emotions.14,15 A review of PHPs’ effectiveness for children suggested that 66% to 99% of treated patients demonstrated improvement and successful return to community-based schools, and family functioning was a major factor in improvement.14 In a follow-up study that surveyed patients via telephone >1 year after discharge from a PHP, almost 80% of the children and adolescents were either “doing OK” or were “well-adjusted.”14 Only 22.5% required inpatient or residential treatment; the majority were doing well in school, with only 7% failing.14 In addition, 60% of parents reported satisfaction with treatment, and 85% reported functional improvement in their children.
Factors that predict PHP success or failure
In an analysis of a day treatment program that provided 4 months of intensive psychodynamic, group-oriented milieu treatment for patients with long-standing personality disorders, Rosie et al16 found 3 factors that contributed to the success of the PHP:
- optimal treatment-patient matching
- judicious use of authority in milieu therapy
- maintaining close relationships with referral sources.
In a study that compared 58 patients who completed an Ottawa hospital PHP and 44 who did not complete the program, psychological mindedness and chronicity of psychiatric illness were found to predict completion.17 However, a study of 59 females with anorexia nervosa who were transferred from inpatient care to an eating disorder day hospital program found that a longer duration of illness, amenorrhea, and a lower body mass index were associated with PHP treatment failure and inpatient rehospitalization.18 One study found that for individuals who were referred to a PHP from inpatient care, suicidal ideation and greater psychotic symptoms were associated with acute inpatient rehospitalization.19 Other factors associated with PHP nonattendance and treatment failure include limited personal and economic resources, high rates of substance abuse disorders, multiple admissions, and disability.20 In a study of 103 alcohol-dependent patients who completed IOP treatment, 64% were abstinent at 6 months follow-up; relapse was associated with a longer duration of alcohol dependence and a higher number of prior treatments, while favorable outcomes were associated with a lower degree of depression, anxiety, and craving.21 Patients with cocaine dependence who completed an IOP showed significant improvements in addiction scores and had more favorable outcomes in employment status and psychological problems if they stayed longer in treatment.22
Bottom Line
Psychiatric partial hospitalization programs (PHPs) provide a transition from inpatient hospitalization to outpatient treatment for patients who need further stabilization, or serve as an alternative to inpatient treatment for patients who don’t need or want inpatient hospitalization. PHPs can be as effective as inpatient treatment for all but the most seriously ill patients, and are more cost-effective than inpatient treatment.
Psychiatric partial hospitalization programs (PHPs), previously known as “day hospitals,” serve to bridge the gap between inpatient and outpatient facilities by providing intensive, highly structured outpatient behavioral health services (typically several hours of psychotherapy each weekday for most days of the week). The concept of PHPs has existed since at least the 1950s, but such programs started to become more common in the United States as the result of legislation passed in 1963 (Box1-3). In this article, I provide a brief introductory review of PHPs, while acknowledging that most research on PHPs was conducted years ago and is rather limited.
Box
The concept of partial hospitalization programs (PHPs) was developed before the 1950s.1 However, in the United States, PHPs did not take hold until Congress passed the Community Mental Health Act of 1963, which required that PHPs must be a core component of Community Mental Health Centers (CMHCs). The Omnibus Budget Reconciliation Acts of 1987 and 1990 required Medicare to pay for PHPs affiliated with or based in CMHCs and psychiatric hospitals, which resulted in a proliferation of PHPs across the country. The number of CMHCbased PHPs grew from 296 in 1993 to 769 in 1997.2 By 2016, more than one-third (38.7%) of all metropolitan hospitals and 11.4% of nonmetropolitan hospitals in the United States provided PHP services.3 This growth was also partially the result of private health insurance companies and the managed care industry clamping down on inpatient hospital stays and approving PHP care to reduce costs. In recent years, freestanding PHPs that are not affiliated with a CMHC or hospital have opened to serve high-functioning patients who do not want inpatient hospitalization or the stigma associated with it.
PHPs: What they are, and how they work
The term “partial hospitalization” is fraught with confusion because initially it was used to contrast such services from full hospitalization. Historically, it was used to describe services for patients who had been discharged home from a state hospital and attended a program on the hospital grounds during the day as outpatients. In reality, today’s PHPs are “day treatment” programs, but the terminology has stuck.
PHPs are neither an inpatient service nor a strict outpatient service, but rather a midground along the continuum of treatment intensity between the 2 traditional types of psychiatric services for patients with a range of mental illness of varying severity. The Association for Ambulatory Behavioral Healthcare, which has set standards and guidelines for PHPs, defines a PHP as “an ambulatory treatment program that includes the major diagnostic, medical, psychiatric, psychosocial, and prevocational treatment modalities designed for patients with serious mental disorders who require coordinated intensive, comprehensive, and multidisciplinary treatment not provided in an outpatient clinical setting.”4 PHPs can render acute care as an alternative to inpatient treatment, provide transitional stabilization treatment between an inpatient stay and traditional outpatient treatment (once a week or less frequent), and function as a supplement to traditional outpatient treatment.
Medicare has established criteria that PHPs must meet to qualify for reimbursement5; these criteria are now widely accepted as standards of care by the insurance industry. To meet the Medicare criteria, PHP treatment must be active and structured to provide an individualized treatment plan that incorporates coordination of services to meet the particular needs of the patient.5 It must include a multidisciplinary team approach to patient care under the direction of a physician, and the treatment goals must be measurable, functional, time-framed, medically necessary, and directly related to the reason for admission.5 The physician must certify the medical necessity for admission by documenting that the patient has a diagnosis of an acute Axis I mental disorder, a level of functioning that includes severe impairments in multiple areas of daily life, and a “reasonable expectation” that the disorder and level of functioning will improve as a result of the treatment.5
The Joint Commission (formerly JCAHO) lumps day treatment, intensive outpatient, partial hospitalization, and adult day care services into a single category of an ambulatory health care environment offering an organized day or night program of assessment, treatment, care, services, habilitation, or rehabilitation for individuals who do not require 24-hour care.6 For behavioral health, this may be a structured, ongoing program that typically meets 2 to 5 times a week for 2 to 5 hours per day.6
Most PHPs for adult patients provide services during the day 5 days per week and average 5 to 6 hours of programming per day. Night or evening programming may be a good option for patients who work during the day. Typically, treatment is provided in a group therapy format, with individual therapy at least once a week. Group therapy may include cognitive-behavioral therapy, coping with grief and loss, trauma recovery, conflict resolution, stress management, anger control, and behavioral modification. Family therapy is provided as needed, but usually is mandatory for children and adolescents. Many PHPs offer intensive outpatient programs (IOPs) as a step down to further facilitate a patient’s adjustment to psychosocial and family functioning while returning to work on a part-time basis. IOPs typically provide 3 to 4 hours of service per day 3 days per week. While not evidence-based, the typical duration of PHP treatment is 4 to 6 weeks, followed by an additional 2 to 4 weeks of IOP.
Continue to: Advantages and disadvantages...
Advantages and disadvantages
Based on a qualitative literature review, Neffinger1 outlined potential advantages and disadvantages of PHPs vs inpatient hospitalization (Table1). While these have not been empirically studied, they may be useful to consider when determining if a PHP would be beneficial for a specific patient.
Which factors are most therapeutic?
Research on which factors of PHPs are of therapeutic value is quite limited and primarily consists of surveys of small numbers of participants. Hoge et al7 explored the active therapeutic factors responsible for change in the Connecticut Mental Health Center PHP by comparing responses of 20 patients with those of their clinicians. Ninety-five percent of patients rated structure as the top therapeutic factor, followed by interpersonal contact, medication, and altruism. Other factors that were rated as important by 40% or fewer participants were catharsis, learning, mobilization of family support, connection to community, universality, patient autonomy, successful completion, security, feedback on behavior, and practice at home. In a British study8 that used a similar method, patients reported that counseling was the most helpful aspect of treatment, followed by medical treatment, while staff picked groups followed by a planned approach.
Evidence supports PHPs’ effectiveness
Some research has suggested that PHPs can be effective, both clinically and in terms of cost. Marshall et al9 conducted a systematic review of the effectiveness of an acute day hospital vs inpatient admission vs outpatient care that included 9 trials. They concluded that psychiatric inpatient admissions could be reduced by at least 23% if patients were diverted to an acute day hospital. They also found some evidence that day treatment programs may be superior to outpatient care in improving symptoms in nonpsychotic patients who are refractory to outpatient treatment. In a systematic review of 18 studies, high rates of satisfaction with PHP services suggested PHPs have an advantage over inpatient treatment within 1 year of discharge; patients and families were more satisfied with PHPs.10 In a study of 197 urban, socioeconomically disadvantaged, severely ill patients, Sledge et al11 compared the clinical outcomes of those who participated in day hospital programs with those of patients who received inpatient care. They found that while overall the 2 approaches produced similar outcomes, there were slightly more positive effects for day hospital programs in measures of symptoms, overall functioning, and social functioning. In terms of cost effectiveness, a 1978 study found that even after correcting for differences in treatment days between inpatient and PHP services, there was a significant financial advantage with PHP (costs were one-third less), primarily because of lower costs per day.12 In another study, PHP cost savings were 20%, and potential savings were higher for nonpsychotic patients.13
Are PHPs appropriate for children and adolescents?
Studies of PHPs for adolescents found that patients made gains in peer relationships, behavioral and academic performance, and control of their emotions.14,15 A review of PHPs’ effectiveness for children suggested that 66% to 99% of treated patients demonstrated improvement and successful return to community-based schools, and family functioning was a major factor in improvement.14 In a follow-up study that surveyed patients via telephone >1 year after discharge from a PHP, almost 80% of the children and adolescents were either “doing OK” or were “well-adjusted.”14 Only 22.5% required inpatient or residential treatment; the majority were doing well in school, with only 7% failing.14 In addition, 60% of parents reported satisfaction with treatment, and 85% reported functional improvement in their children.
Factors that predict PHP success or failure
In an analysis of a day treatment program that provided 4 months of intensive psychodynamic, group-oriented milieu treatment for patients with long-standing personality disorders, Rosie et al16 found 3 factors that contributed to the success of the PHP:
- optimal treatment-patient matching
- judicious use of authority in milieu therapy
- maintaining close relationships with referral sources.
In a study that compared 58 patients who completed an Ottawa hospital PHP and 44 who did not complete the program, psychological mindedness and chronicity of psychiatric illness were found to predict completion.17 However, a study of 59 females with anorexia nervosa who were transferred from inpatient care to an eating disorder day hospital program found that a longer duration of illness, amenorrhea, and a lower body mass index were associated with PHP treatment failure and inpatient rehospitalization.18 One study found that for individuals who were referred to a PHP from inpatient care, suicidal ideation and greater psychotic symptoms were associated with acute inpatient rehospitalization.19 Other factors associated with PHP nonattendance and treatment failure include limited personal and economic resources, high rates of substance abuse disorders, multiple admissions, and disability.20 In a study of 103 alcohol-dependent patients who completed IOP treatment, 64% were abstinent at 6 months follow-up; relapse was associated with a longer duration of alcohol dependence and a higher number of prior treatments, while favorable outcomes were associated with a lower degree of depression, anxiety, and craving.21 Patients with cocaine dependence who completed an IOP showed significant improvements in addiction scores and had more favorable outcomes in employment status and psychological problems if they stayed longer in treatment.22
Bottom Line
Psychiatric partial hospitalization programs (PHPs) provide a transition from inpatient hospitalization to outpatient treatment for patients who need further stabilization, or serve as an alternative to inpatient treatment for patients who don’t need or want inpatient hospitalization. PHPs can be as effective as inpatient treatment for all but the most seriously ill patients, and are more cost-effective than inpatient treatment.
1. Neffinger GG. Partial hospitalization: an overview. J Community Psychol. 1981;9(3):262-269.
2. Leung MY, Drozd EM, Healy DA, et al. Impacts associated with the Medicare Psychiatric PPS: a study of partial hospitalization programs. February 2009. Accessed January 8, 2022. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Reports/downloads/Leung_PHP_PPS_2010.pdf
3. Williams T, Borders TF, Jasinski L. Partial Psychiatric Hospitalization Program Availability in Non-Metropolitan and Non-Metropolitan Hospitals Nationally. Rural and Underserved Health Research Center; 2019.
4. Rosser J, Michael S, eds. Standards and guidelines for partial hospital programs and intensive outpatient programs. Association for Ambulatory Behavioral Healthcare. 2018. Accessed January 8, 2022. https://aabh.org/wp-content/uploads/2021/05/2021-SandG-Final.pdf
5. CMS Manual System PUB. 100-02 Medicare Benefit Policy: Partial Hospitalization Services, Department of Health and Human Services. Centers for Medicare & Medicaid Services; 2004:6-9.
6. Joint Commission. Guide to Joint Commission Behavioral Healthcare Accreditation. Joint Commission; 2007:36.
7. Hoge MA, Farrell SP, Munchel ME, et al. Therapeutic factors in partial hospitalization. Psychiatry. 1988;51(2):199-210.
8. Ricketts T, Kirshbaum MN. Helpfulness of mental health day care: client and staff views. J Adv Nurs. 1994;20(2):297-306.
9. Marshall M, Crowther R, Almaraz-Serrano A, et al. Systematic reviews of the effectiveness of day care for people with severe mental disorders: (1) acute day hospital versus admission; (2) vocational rehabilitation; (3) day hospital versus outpatient care. Health Technol Assess. 2001;5(21):1-75.
10. Horvitz-Lennon M, Normand SL, Gaccione P, et al. Partial versus full hospitalization for adults in psychiatric distress: a systematic review of the published literature (1957-1997). Am J Psychiatry. 2001;158(5):676-685.
11. Sledge WH, Tebes J, Rakfeldt J, et al. Day hospital/crisis respite care versus inpatient care, Part I: Clinical outcomes. Am J Psychiatry. 1996;153(8):1065-1073.
12. Fink EB, Longabaugh R, Stout R. The paradoxical underutilization of partial hospitalization. Am J Psychiatry. 1978;135(6):713-716.
13. Sledge WH, Tebes J, Wolff N, et al. Day hospital/crisis respite care versus inpatient care, Part II: service utilization and costs. Am J Psychiatry. 1996;153(8):1074-1083.
14. Kiser LJ. Treatment-effectiveness research in child and adolescent partial hospitalization. Psychiatr Hosp. 1991;22(2):51-8.
15. Milin R, Coupland K, Walker S, et al. Outcome and follow-up study of an adolescent psychiatric day treatment school program. J Am Acad Child Adolesc Psychiatry. 2000;39(3):320-328.
16. Rosie JS, Azim HF, Piper WE, et al. Effective psychiatric day treatment: historical lessons. Psychiatr Serv. 1995;46(10):1019-1026.
17. Tasca GA, Balfour L, Bissada H, et al. Treatment completion and outcome in a partial hospitalization program: interactions among patient variables. Psychotherapy Res. 1999;9(2):232-247.
18. Howard WT, Evans KK, Quintero-Howard CV, et al. Predictors of success or failure of transition to day hospital treatment for inpatients with anorexia nervosa. Am J Psychiatry. 1999;156(11):1697-1702.
19. Beard C, Hearon BA, Lee J, et al. When partial hospitalization fails: risk factors for inpatient hospitalization. J Nerv Ment Dis. 2016;204(6):431-436.
20. Lieberman PB, Guggenheim FG. Reasons for patient nonattendance during acute partial hospitalization. Psychiatr Serv. 2016;67(6):684-687.
21. Bottlender M, Soyka M. Efficacy of an intensive outpatient rehabilitation program in alcoholism: predictors of outcome 6 months after treatment. Eur Addict Res. 2005;11(3):132-137.
22. Gottheil E, Weinstein SP, Sterling RC, et al. A randomized controlled study of the effectiveness of intensive outpatient treatment for cocaine dependence. Psychiatr Serv. 1998;49(6):782-787.
1. Neffinger GG. Partial hospitalization: an overview. J Community Psychol. 1981;9(3):262-269.
2. Leung MY, Drozd EM, Healy DA, et al. Impacts associated with the Medicare Psychiatric PPS: a study of partial hospitalization programs. February 2009. Accessed January 8, 2022. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Reports/downloads/Leung_PHP_PPS_2010.pdf
3. Williams T, Borders TF, Jasinski L. Partial Psychiatric Hospitalization Program Availability in Non-Metropolitan and Non-Metropolitan Hospitals Nationally. Rural and Underserved Health Research Center; 2019.
4. Rosser J, Michael S, eds. Standards and guidelines for partial hospital programs and intensive outpatient programs. Association for Ambulatory Behavioral Healthcare. 2018. Accessed January 8, 2022. https://aabh.org/wp-content/uploads/2021/05/2021-SandG-Final.pdf
5. CMS Manual System PUB. 100-02 Medicare Benefit Policy: Partial Hospitalization Services, Department of Health and Human Services. Centers for Medicare & Medicaid Services; 2004:6-9.
6. Joint Commission. Guide to Joint Commission Behavioral Healthcare Accreditation. Joint Commission; 2007:36.
7. Hoge MA, Farrell SP, Munchel ME, et al. Therapeutic factors in partial hospitalization. Psychiatry. 1988;51(2):199-210.
8. Ricketts T, Kirshbaum MN. Helpfulness of mental health day care: client and staff views. J Adv Nurs. 1994;20(2):297-306.
9. Marshall M, Crowther R, Almaraz-Serrano A, et al. Systematic reviews of the effectiveness of day care for people with severe mental disorders: (1) acute day hospital versus admission; (2) vocational rehabilitation; (3) day hospital versus outpatient care. Health Technol Assess. 2001;5(21):1-75.
10. Horvitz-Lennon M, Normand SL, Gaccione P, et al. Partial versus full hospitalization for adults in psychiatric distress: a systematic review of the published literature (1957-1997). Am J Psychiatry. 2001;158(5):676-685.
11. Sledge WH, Tebes J, Rakfeldt J, et al. Day hospital/crisis respite care versus inpatient care, Part I: Clinical outcomes. Am J Psychiatry. 1996;153(8):1065-1073.
12. Fink EB, Longabaugh R, Stout R. The paradoxical underutilization of partial hospitalization. Am J Psychiatry. 1978;135(6):713-716.
13. Sledge WH, Tebes J, Wolff N, et al. Day hospital/crisis respite care versus inpatient care, Part II: service utilization and costs. Am J Psychiatry. 1996;153(8):1074-1083.
14. Kiser LJ. Treatment-effectiveness research in child and adolescent partial hospitalization. Psychiatr Hosp. 1991;22(2):51-8.
15. Milin R, Coupland K, Walker S, et al. Outcome and follow-up study of an adolescent psychiatric day treatment school program. J Am Acad Child Adolesc Psychiatry. 2000;39(3):320-328.
16. Rosie JS, Azim HF, Piper WE, et al. Effective psychiatric day treatment: historical lessons. Psychiatr Serv. 1995;46(10):1019-1026.
17. Tasca GA, Balfour L, Bissada H, et al. Treatment completion and outcome in a partial hospitalization program: interactions among patient variables. Psychotherapy Res. 1999;9(2):232-247.
18. Howard WT, Evans KK, Quintero-Howard CV, et al. Predictors of success or failure of transition to day hospital treatment for inpatients with anorexia nervosa. Am J Psychiatry. 1999;156(11):1697-1702.
19. Beard C, Hearon BA, Lee J, et al. When partial hospitalization fails: risk factors for inpatient hospitalization. J Nerv Ment Dis. 2016;204(6):431-436.
20. Lieberman PB, Guggenheim FG. Reasons for patient nonattendance during acute partial hospitalization. Psychiatr Serv. 2016;67(6):684-687.
21. Bottlender M, Soyka M. Efficacy of an intensive outpatient rehabilitation program in alcoholism: predictors of outcome 6 months after treatment. Eur Addict Res. 2005;11(3):132-137.
22. Gottheil E, Weinstein SP, Sterling RC, et al. A randomized controlled study of the effectiveness of intensive outpatient treatment for cocaine dependence. Psychiatr Serv. 1998;49(6):782-787.
It’s time for moonshot thinking in psychiatry
“I believe that this nation should commit itself to achieving the goal, before the decade is out, of landing a man on the Moon and returning him safely to Earth.”
President John F. Kennedy, May 25, 1961
Despite significant progress, there remain many unmet needs in psychiatry. These include a granular understanding of the neurobiology of various psychopathologies, an objective and valid diagnostic schema, and disease-modifying treatments for chronic and disabling psychiatric disorders. Several moonshots are needed to address those festering needs.
A “moonshot” is an extremely ambitious, dramatic, imaginative, and inspiring goal. Landing on the Moon was generally believed to be impossible when President Kennedy boldly set that as a goal for the United States in 1961. Yet, 8 short years later, on July 20, 1969, Neil Armstrong stepped off the lunar module ladder onto the Moon’s surface, a feat that captured the imagination of the nation and the world. I distinctly remember watching it on television with amazement as a young boy. It was a surreal experience. That’s what achieving a moonshot feels like.
Successful organizations should always have 1 or more moonshots (American Psychiatric Association and National Institute of Mental Health [NIMH], are you listening?). Setting lofty goals that require monumental determination and effort to accomplish will have a transformative, long-lasting impact. The construction of the Panama Canal to connect 2 oceans and the Manhattan Project to develop the first nuclear bomb, which ended World War II, are examples of moonshots that continue to reverberate. A more recent moonshot is the driverless car, which in the past was a laughable idea but is now a reality that will change society and the world in many ways. Innovative billionaire moguls now speak loudly about colonizing Mars, which sounds improbable and highly risky, but it’s a moonshot that may be achieved within a few years. Establishing world peace is a moonshot that requires collective Kennedy-esque vision and motivation among world leaders, which currently is sadly lacking.
So, for contemporary psychiatry, what is the equivalent of landing on the Moon? Here is the list that pops in my brain’s mind (let us know which of these would be your top 3 moonshots by taking our survey at https://bit.ly/3qkKqTa):
- A cure for schizophrenia (across positive, negative, and cognitive symptom domains)
- A cure for mood disorders, unipolar and bipolar (including suicide)
- A cure for anxiety disorders
- A cure for obsessive-compulsive disorder
- A cure for posttraumatic stress disorder
- A cure for alcoholism/addiction
- A cure for autism
- A cure for Alzheimer’s disease and other dementias
- A cure for personality disorders, especially antisocial and borderline
- A cure for the visceral hatred across political parties that permeates our society (obviously not a psychiatric category, but perhaps it should be added to DSM because it is so destructive).
Those moonshots may be regarded as absurd, and totally unachievable, but so was landing on the Moon, until it was accomplished. Psychiatry must stop thinking small and being content with tiny advances (which is like changing the chairs to more comfortable sofas on the deck of the Titanic and calling it “progress…”). Psychiatry needs to be unified under the flag of “moonshot thinking” by several visionary and transformative leaders to start believing in a miraculously better future for our patients. But to pave the way for moonshots in psychiatry, the leading organizations must collaborate closely to open the door for unprecedented scientific and medical breakthroughs of a moonshot by:
- Lobbying effectively to secure massive funding for research from federal, state, corporate, and foundation sources (perhaps convincing the Gates Foundation that schizophrenia is as devastating worldwide as malaria may bring a few badly needed billions into psychiatric brain research).
- Reminding members of Congress that in the United States, costs associated with psychiatric brain disorders total an estimated $700 billion annually,1 and that this must be addressed by boosting the meager NIMH budget by at least an order of magnitude. The NIMH should disproportionately invest its resources on severe brain disorders such as schizophrenia because breakthrough advances in its neurobiology will provide unprecedented insights to the pathophysiology of other severe psychiatric brain disorders.
- Partnering intimately with the pharmaceutical industry in a powerful public-private coalition to exploit the extensive research infrastructure of this industry.
- Creating the necessary army of researchers (physician-scientists) by providing huge incentives to medical students and psychiatric residents to pursue careers in neuroscience research. Incentives can include paying for an individual’s entire medical education and research training, and providing generous salaries that match or exceed the income of a very successful clinical practice.
- Convincing all psychiatric clinicians to support research by referring patients to research projects. Clinical psychiatrists are badly needed to care for the population, but they must be reminded that every treatment they are using today was a research project in the past, and that the research of today will evolve into the treatments (or cures) of tomorrow.
Pursuing lofty moonshots via innovative research is very likely to enhance serendipity and lead to unexpected discoveries along the way. As Louis Pasteur said, “chance only favors the prepared mind.”2 Moonshot thinking in psychiatry today is more feasible than ever before because of the many advances in research methods (neuroimaging, pluripotent cells, optogenetics, CRISPR, etc) and complex data management technologies (big data, machine learning, artificial intelligence), each of which qualifies as a preparatory moonshot in its own right.
Given the tragic consequences of psychiatric brain disorders, it is imperative that we “think big.” Humanity expects us to do that. We must envision the future of psychiatry as dramatically different from the present. Moonshot thinking is the indispensable vehicle to take us there.
1. Discovery Mood and Anxiety Program. The rising cost of mental health and substance abuse in the United States. Accessed January 13, 2022. https://discoverymood.com/blog/cost-of-mental-health-increase/
2. Wikiquote. Louis Pasteur. Accessed January 10, 2022. https://en.wikiquote.org/wiki/Louis_Pasteur
“I believe that this nation should commit itself to achieving the goal, before the decade is out, of landing a man on the Moon and returning him safely to Earth.”
President John F. Kennedy, May 25, 1961
Despite significant progress, there remain many unmet needs in psychiatry. These include a granular understanding of the neurobiology of various psychopathologies, an objective and valid diagnostic schema, and disease-modifying treatments for chronic and disabling psychiatric disorders. Several moonshots are needed to address those festering needs.
A “moonshot” is an extremely ambitious, dramatic, imaginative, and inspiring goal. Landing on the Moon was generally believed to be impossible when President Kennedy boldly set that as a goal for the United States in 1961. Yet, 8 short years later, on July 20, 1969, Neil Armstrong stepped off the lunar module ladder onto the Moon’s surface, a feat that captured the imagination of the nation and the world. I distinctly remember watching it on television with amazement as a young boy. It was a surreal experience. That’s what achieving a moonshot feels like.
Successful organizations should always have 1 or more moonshots (American Psychiatric Association and National Institute of Mental Health [NIMH], are you listening?). Setting lofty goals that require monumental determination and effort to accomplish will have a transformative, long-lasting impact. The construction of the Panama Canal to connect 2 oceans and the Manhattan Project to develop the first nuclear bomb, which ended World War II, are examples of moonshots that continue to reverberate. A more recent moonshot is the driverless car, which in the past was a laughable idea but is now a reality that will change society and the world in many ways. Innovative billionaire moguls now speak loudly about colonizing Mars, which sounds improbable and highly risky, but it’s a moonshot that may be achieved within a few years. Establishing world peace is a moonshot that requires collective Kennedy-esque vision and motivation among world leaders, which currently is sadly lacking.
So, for contemporary psychiatry, what is the equivalent of landing on the Moon? Here is the list that pops in my brain’s mind (let us know which of these would be your top 3 moonshots by taking our survey at https://bit.ly/3qkKqTa):
- A cure for schizophrenia (across positive, negative, and cognitive symptom domains)
- A cure for mood disorders, unipolar and bipolar (including suicide)
- A cure for anxiety disorders
- A cure for obsessive-compulsive disorder
- A cure for posttraumatic stress disorder
- A cure for alcoholism/addiction
- A cure for autism
- A cure for Alzheimer’s disease and other dementias
- A cure for personality disorders, especially antisocial and borderline
- A cure for the visceral hatred across political parties that permeates our society (obviously not a psychiatric category, but perhaps it should be added to DSM because it is so destructive).
Those moonshots may be regarded as absurd, and totally unachievable, but so was landing on the Moon, until it was accomplished. Psychiatry must stop thinking small and being content with tiny advances (which is like changing the chairs to more comfortable sofas on the deck of the Titanic and calling it “progress…”). Psychiatry needs to be unified under the flag of “moonshot thinking” by several visionary and transformative leaders to start believing in a miraculously better future for our patients. But to pave the way for moonshots in psychiatry, the leading organizations must collaborate closely to open the door for unprecedented scientific and medical breakthroughs of a moonshot by:
- Lobbying effectively to secure massive funding for research from federal, state, corporate, and foundation sources (perhaps convincing the Gates Foundation that schizophrenia is as devastating worldwide as malaria may bring a few badly needed billions into psychiatric brain research).
- Reminding members of Congress that in the United States, costs associated with psychiatric brain disorders total an estimated $700 billion annually,1 and that this must be addressed by boosting the meager NIMH budget by at least an order of magnitude. The NIMH should disproportionately invest its resources on severe brain disorders such as schizophrenia because breakthrough advances in its neurobiology will provide unprecedented insights to the pathophysiology of other severe psychiatric brain disorders.
- Partnering intimately with the pharmaceutical industry in a powerful public-private coalition to exploit the extensive research infrastructure of this industry.
- Creating the necessary army of researchers (physician-scientists) by providing huge incentives to medical students and psychiatric residents to pursue careers in neuroscience research. Incentives can include paying for an individual’s entire medical education and research training, and providing generous salaries that match or exceed the income of a very successful clinical practice.
- Convincing all psychiatric clinicians to support research by referring patients to research projects. Clinical psychiatrists are badly needed to care for the population, but they must be reminded that every treatment they are using today was a research project in the past, and that the research of today will evolve into the treatments (or cures) of tomorrow.
Pursuing lofty moonshots via innovative research is very likely to enhance serendipity and lead to unexpected discoveries along the way. As Louis Pasteur said, “chance only favors the prepared mind.”2 Moonshot thinking in psychiatry today is more feasible than ever before because of the many advances in research methods (neuroimaging, pluripotent cells, optogenetics, CRISPR, etc) and complex data management technologies (big data, machine learning, artificial intelligence), each of which qualifies as a preparatory moonshot in its own right.
Given the tragic consequences of psychiatric brain disorders, it is imperative that we “think big.” Humanity expects us to do that. We must envision the future of psychiatry as dramatically different from the present. Moonshot thinking is the indispensable vehicle to take us there.
“I believe that this nation should commit itself to achieving the goal, before the decade is out, of landing a man on the Moon and returning him safely to Earth.”
President John F. Kennedy, May 25, 1961
Despite significant progress, there remain many unmet needs in psychiatry. These include a granular understanding of the neurobiology of various psychopathologies, an objective and valid diagnostic schema, and disease-modifying treatments for chronic and disabling psychiatric disorders. Several moonshots are needed to address those festering needs.
A “moonshot” is an extremely ambitious, dramatic, imaginative, and inspiring goal. Landing on the Moon was generally believed to be impossible when President Kennedy boldly set that as a goal for the United States in 1961. Yet, 8 short years later, on July 20, 1969, Neil Armstrong stepped off the lunar module ladder onto the Moon’s surface, a feat that captured the imagination of the nation and the world. I distinctly remember watching it on television with amazement as a young boy. It was a surreal experience. That’s what achieving a moonshot feels like.
Successful organizations should always have 1 or more moonshots (American Psychiatric Association and National Institute of Mental Health [NIMH], are you listening?). Setting lofty goals that require monumental determination and effort to accomplish will have a transformative, long-lasting impact. The construction of the Panama Canal to connect 2 oceans and the Manhattan Project to develop the first nuclear bomb, which ended World War II, are examples of moonshots that continue to reverberate. A more recent moonshot is the driverless car, which in the past was a laughable idea but is now a reality that will change society and the world in many ways. Innovative billionaire moguls now speak loudly about colonizing Mars, which sounds improbable and highly risky, but it’s a moonshot that may be achieved within a few years. Establishing world peace is a moonshot that requires collective Kennedy-esque vision and motivation among world leaders, which currently is sadly lacking.
So, for contemporary psychiatry, what is the equivalent of landing on the Moon? Here is the list that pops in my brain’s mind (let us know which of these would be your top 3 moonshots by taking our survey at https://bit.ly/3qkKqTa):
- A cure for schizophrenia (across positive, negative, and cognitive symptom domains)
- A cure for mood disorders, unipolar and bipolar (including suicide)
- A cure for anxiety disorders
- A cure for obsessive-compulsive disorder
- A cure for posttraumatic stress disorder
- A cure for alcoholism/addiction
- A cure for autism
- A cure for Alzheimer’s disease and other dementias
- A cure for personality disorders, especially antisocial and borderline
- A cure for the visceral hatred across political parties that permeates our society (obviously not a psychiatric category, but perhaps it should be added to DSM because it is so destructive).
Those moonshots may be regarded as absurd, and totally unachievable, but so was landing on the Moon, until it was accomplished. Psychiatry must stop thinking small and being content with tiny advances (which is like changing the chairs to more comfortable sofas on the deck of the Titanic and calling it “progress…”). Psychiatry needs to be unified under the flag of “moonshot thinking” by several visionary and transformative leaders to start believing in a miraculously better future for our patients. But to pave the way for moonshots in psychiatry, the leading organizations must collaborate closely to open the door for unprecedented scientific and medical breakthroughs of a moonshot by:
- Lobbying effectively to secure massive funding for research from federal, state, corporate, and foundation sources (perhaps convincing the Gates Foundation that schizophrenia is as devastating worldwide as malaria may bring a few badly needed billions into psychiatric brain research).
- Reminding members of Congress that in the United States, costs associated with psychiatric brain disorders total an estimated $700 billion annually,1 and that this must be addressed by boosting the meager NIMH budget by at least an order of magnitude. The NIMH should disproportionately invest its resources on severe brain disorders such as schizophrenia because breakthrough advances in its neurobiology will provide unprecedented insights to the pathophysiology of other severe psychiatric brain disorders.
- Partnering intimately with the pharmaceutical industry in a powerful public-private coalition to exploit the extensive research infrastructure of this industry.
- Creating the necessary army of researchers (physician-scientists) by providing huge incentives to medical students and psychiatric residents to pursue careers in neuroscience research. Incentives can include paying for an individual’s entire medical education and research training, and providing generous salaries that match or exceed the income of a very successful clinical practice.
- Convincing all psychiatric clinicians to support research by referring patients to research projects. Clinical psychiatrists are badly needed to care for the population, but they must be reminded that every treatment they are using today was a research project in the past, and that the research of today will evolve into the treatments (or cures) of tomorrow.
Pursuing lofty moonshots via innovative research is very likely to enhance serendipity and lead to unexpected discoveries along the way. As Louis Pasteur said, “chance only favors the prepared mind.”2 Moonshot thinking in psychiatry today is more feasible than ever before because of the many advances in research methods (neuroimaging, pluripotent cells, optogenetics, CRISPR, etc) and complex data management technologies (big data, machine learning, artificial intelligence), each of which qualifies as a preparatory moonshot in its own right.
Given the tragic consequences of psychiatric brain disorders, it is imperative that we “think big.” Humanity expects us to do that. We must envision the future of psychiatry as dramatically different from the present. Moonshot thinking is the indispensable vehicle to take us there.
1. Discovery Mood and Anxiety Program. The rising cost of mental health and substance abuse in the United States. Accessed January 13, 2022. https://discoverymood.com/blog/cost-of-mental-health-increase/
2. Wikiquote. Louis Pasteur. Accessed January 10, 2022. https://en.wikiquote.org/wiki/Louis_Pasteur
1. Discovery Mood and Anxiety Program. The rising cost of mental health and substance abuse in the United States. Accessed January 13, 2022. https://discoverymood.com/blog/cost-of-mental-health-increase/
2. Wikiquote. Louis Pasteur. Accessed January 10, 2022. https://en.wikiquote.org/wiki/Louis_Pasteur