Mental Health

Screening for cognitive impairment should be part of multidisciplinary care for stroke survivors, the American Heart Association says in a new scientific statement.

“Cognitive impairment after stroke is very common, is associated with other post-stroke outcomes, and often has significant impact on the quality of life,” Nada El Husseini, MD, MHSc, chair of the scientific statement writing group, told this news organization.

“It is important to screen stroke survivors for cognitive impairment as well as for associated comorbidities such as mood and sleep disorders,” said Dr. El Husseini, associate professor of neurology at Duke University Medical Center in Durham, N.C.

The scientific statement was published online in Stroke. It’s the first to specifically focus on the cognitive impairment resulting from an overt stroke (ischemic or hemorrhagic).
 

‘Actionable’ considerations for care

The writing group performed a “scoping” review of the literature on the prevalence, diagnosis, and management of poststroke cognitive impairment (PSCI) to provide a framework for “actionable considerations” for clinical practice as well as to highlight gaps needing additional studies, Dr. El Husseini explained.

PSCI, ranging from mild to severe, occurs in up to 60% of stroke survivors in the first year after stroke; yet, it is often underreported and underdiagnosed, the writing group notes.

Up to 20% of stroke survivors who experience mild cognitive impairment fully recover cognitive function, and cognitive recovery is most likely within the first 6 months after a stroke.

However, improvement in cognitive impairment without return to prestroke levels is more frequent than is complete recovery. As many as one in three stroke survivors may develop dementia within 5 years of stroke.

The writing group also notes that PSCI is often associated with other conditions, including physical disability, sleep disorders, behavioral and personality changes, depression, and other neuropsychological changes – each of which may contribute to lower quality of life.

Currently, there is no “gold standard” for cognitive screening following stroke, but several brief cognitive screening tests, including the Mini–Mental State Examination and the Montreal Cognitive Assessment, are widely used to identify cognitive impairment after stroke.

The statement also highlights the importance of assessing cognitive changes over time after stroke. Stroke survivors who experience unexplained difficulties with cognitive-related activities of daily living, following care instructions, or providing a reliable health history may be candidates for additional cognitive screening.
 

Manage risk factors to prevent repeat stroke

“Anticipatory guidance regarding home and driving safety and, return to work (if applicable) along with interdisciplinary collaboration among different medical and ancillary specialists in the diagnosis and management of cognitive impairment is key for the holistic care of stroke survivors,” Dr. El Husseini told this news organization.

The multidisciplinary poststroke health care team could include neurologists, occupational therapists, speech therapists, nurses, neuropsychologists, gerontologists, and primary care providers.

“Because recurrent stroke is strongly associated with the development of cognitive impairment and dementia, prevention of recurrent strokes should be sought to decrease that risk,” Dr. El Husseini said. This includes addressing stroke risk factors, including high blood pressure, high cholesterol, type 2 diabetes, and atrial fibrillation.

The writing group says research is needed in the future to determine how cognitive impairment develops after stroke and the impact of nonbrain factors, including infection, frailty, and social factors.

Further research is also needed to determine best practices for cognitive screening after stroke, including the development and use of screening instruments that consider demographic, cultural, and linguistic factors in determining “normal” function.

“Perhaps the most pressing need, however, is the development of effective and culturally relevant treatments for poststroke cognitive impairment,” Dr. El Husseini said in a news release.

“We hope to see big enough clinical trials that assess various techniques, medications, and lifestyle changes in diverse groups of patients that may help improve cognitive function,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular Radiology and Intervention, the Council on Hypertension, and the Council on Lifestyle and Cardiometabolic Health.
 

Screening for cognitive impairment should be part of multidisciplinary care for stroke survivors, the American Heart Association says in a new scientific statement.

“Cognitive impairment after stroke is very common, is associated with other post-stroke outcomes, and often has significant impact on the quality of life,” Nada El Husseini, MD, MHSc, chair of the scientific statement writing group, told this news organization.

“It is important to screen stroke survivors for cognitive impairment as well as for associated comorbidities such as mood and sleep disorders,” said Dr. El Husseini, associate professor of neurology at Duke University Medical Center in Durham, N.C.

The scientific statement was published online in Stroke. It’s the first to specifically focus on the cognitive impairment resulting from an overt stroke (ischemic or hemorrhagic).
 

‘Actionable’ considerations for care

The writing group performed a “scoping” review of the literature on the prevalence, diagnosis, and management of poststroke cognitive impairment (PSCI) to provide a framework for “actionable considerations” for clinical practice as well as to highlight gaps needing additional studies, Dr. El Husseini explained.

PSCI, ranging from mild to severe, occurs in up to 60% of stroke survivors in the first year after stroke; yet, it is often underreported and underdiagnosed, the writing group notes.

Up to 20% of stroke survivors who experience mild cognitive impairment fully recover cognitive function, and cognitive recovery is most likely within the first 6 months after a stroke.

However, improvement in cognitive impairment without return to prestroke levels is more frequent than is complete recovery. As many as one in three stroke survivors may develop dementia within 5 years of stroke.

The writing group also notes that PSCI is often associated with other conditions, including physical disability, sleep disorders, behavioral and personality changes, depression, and other neuropsychological changes – each of which may contribute to lower quality of life.

Currently, there is no “gold standard” for cognitive screening following stroke, but several brief cognitive screening tests, including the Mini–Mental State Examination and the Montreal Cognitive Assessment, are widely used to identify cognitive impairment after stroke.

The statement also highlights the importance of assessing cognitive changes over time after stroke. Stroke survivors who experience unexplained difficulties with cognitive-related activities of daily living, following care instructions, or providing a reliable health history may be candidates for additional cognitive screening.
 

Manage risk factors to prevent repeat stroke

“Anticipatory guidance regarding home and driving safety and, return to work (if applicable) along with interdisciplinary collaboration among different medical and ancillary specialists in the diagnosis and management of cognitive impairment is key for the holistic care of stroke survivors,” Dr. El Husseini told this news organization.

The multidisciplinary poststroke health care team could include neurologists, occupational therapists, speech therapists, nurses, neuropsychologists, gerontologists, and primary care providers.

“Because recurrent stroke is strongly associated with the development of cognitive impairment and dementia, prevention of recurrent strokes should be sought to decrease that risk,” Dr. El Husseini said. This includes addressing stroke risk factors, including high blood pressure, high cholesterol, type 2 diabetes, and atrial fibrillation.

The writing group says research is needed in the future to determine how cognitive impairment develops after stroke and the impact of nonbrain factors, including infection, frailty, and social factors.

Further research is also needed to determine best practices for cognitive screening after stroke, including the development and use of screening instruments that consider demographic, cultural, and linguistic factors in determining “normal” function.

“Perhaps the most pressing need, however, is the development of effective and culturally relevant treatments for poststroke cognitive impairment,” Dr. El Husseini said in a news release.

“We hope to see big enough clinical trials that assess various techniques, medications, and lifestyle changes in diverse groups of patients that may help improve cognitive function,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular Radiology and Intervention, the Council on Hypertension, and the Council on Lifestyle and Cardiometabolic Health.
 

Screening for cognitive impairment should be part of multidisciplinary care for stroke survivors, the American Heart Association says in a new scientific statement.

“Cognitive impairment after stroke is very common, is associated with other post-stroke outcomes, and often has significant impact on the quality of life,” Nada El Husseini, MD, MHSc, chair of the scientific statement writing group, told this news organization.

“It is important to screen stroke survivors for cognitive impairment as well as for associated comorbidities such as mood and sleep disorders,” said Dr. El Husseini, associate professor of neurology at Duke University Medical Center in Durham, N.C.

The scientific statement was published online in Stroke. It’s the first to specifically focus on the cognitive impairment resulting from an overt stroke (ischemic or hemorrhagic).
 

‘Actionable’ considerations for care

The writing group performed a “scoping” review of the literature on the prevalence, diagnosis, and management of poststroke cognitive impairment (PSCI) to provide a framework for “actionable considerations” for clinical practice as well as to highlight gaps needing additional studies, Dr. El Husseini explained.

PSCI, ranging from mild to severe, occurs in up to 60% of stroke survivors in the first year after stroke; yet, it is often underreported and underdiagnosed, the writing group notes.

Up to 20% of stroke survivors who experience mild cognitive impairment fully recover cognitive function, and cognitive recovery is most likely within the first 6 months after a stroke.

However, improvement in cognitive impairment without return to prestroke levels is more frequent than is complete recovery. As many as one in three stroke survivors may develop dementia within 5 years of stroke.

The writing group also notes that PSCI is often associated with other conditions, including physical disability, sleep disorders, behavioral and personality changes, depression, and other neuropsychological changes – each of which may contribute to lower quality of life.

Currently, there is no “gold standard” for cognitive screening following stroke, but several brief cognitive screening tests, including the Mini–Mental State Examination and the Montreal Cognitive Assessment, are widely used to identify cognitive impairment after stroke.

The statement also highlights the importance of assessing cognitive changes over time after stroke. Stroke survivors who experience unexplained difficulties with cognitive-related activities of daily living, following care instructions, or providing a reliable health history may be candidates for additional cognitive screening.
 

Manage risk factors to prevent repeat stroke

“Anticipatory guidance regarding home and driving safety and, return to work (if applicable) along with interdisciplinary collaboration among different medical and ancillary specialists in the diagnosis and management of cognitive impairment is key for the holistic care of stroke survivors,” Dr. El Husseini told this news organization.

The multidisciplinary poststroke health care team could include neurologists, occupational therapists, speech therapists, nurses, neuropsychologists, gerontologists, and primary care providers.

“Because recurrent stroke is strongly associated with the development of cognitive impairment and dementia, prevention of recurrent strokes should be sought to decrease that risk,” Dr. El Husseini said. This includes addressing stroke risk factors, including high blood pressure, high cholesterol, type 2 diabetes, and atrial fibrillation.

The writing group says research is needed in the future to determine how cognitive impairment develops after stroke and the impact of nonbrain factors, including infection, frailty, and social factors.

Further research is also needed to determine best practices for cognitive screening after stroke, including the development and use of screening instruments that consider demographic, cultural, and linguistic factors in determining “normal” function.

“Perhaps the most pressing need, however, is the development of effective and culturally relevant treatments for poststroke cognitive impairment,” Dr. El Husseini said in a news release.

“We hope to see big enough clinical trials that assess various techniques, medications, and lifestyle changes in diverse groups of patients that may help improve cognitive function,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular Radiology and Intervention, the Council on Hypertension, and the Council on Lifestyle and Cardiometabolic Health.
 

Initiation of buprenorphine in hospitals in the United States has plateaued since 2018, with low retention rates of less than 25%, based on data from more than 3 million individuals who began buprenorphine between January 2016 and October 2022.

University of Michigan

Opioid overdose deaths are at a record high in the United States, and many of these deaths can be prevented with medications such as buprenorphine, said lead author Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, in an interview. “However, buprenorphine cannot prevent opioid overdose deaths if patients are never started on the medication or only stay on the medication for a short time. For that reason, rates of buprenorphine initiation and retention are critical metrics for measuring how well the U.S. health care system is responding to the opioid epidemic,” he said.

“At the time we started our study, several other research groups had evaluated U.S. rates of buprenorphine initiation and retention using data through 2020. However, more recent national data were lacking,” Dr. Chua told this news organization. “We felt that this was an important knowledge gap given the many changes in society that have occurred since 2020,” he noted. “For example, it was possible that the relaxation of social distancing measures during 2021 and 2022 might have reduced barriers to health care visits, thereby increasing opportunities to initiate treatment for opioid addiction with buprenorphine,” he said.

Dr. Chua and colleagues used data from the IQVIA Longitudinal Prescription Database, which reports 92% of prescriptions dispensed from retail pharmacies in the United States. “Buprenorphine products included immediate-release and extended-release formulations approved for opioid use disorder but not formulations primarily used to treat pain,” they write.

Monthly buprenorphine initiation was defined as the number of patients initiating therapy per 100,000 individuals. For retention, the researchers used a National Quality Forum-endorsed quality measure that defined retention as continuous use of buprenorphine for at least 180 days.

A total of 3,006,629 patients began buprenorphine therapy during the study period; approximately 43% were female.

During the first years of the study period, from January 2016 through September 2018, the monthly buprenorphine initiation rate increased from 12.5 per 100,000 to 15.9 per 100,000, with a statistically significant monthly percentage change of 0.62% (P < .001).

However, from October 2018 through October 2022, the monthly percentage remained essentially the same (P = .62) with a monthly percentage change of −0.03%.

From March 2020 through December 2020, the median monthly buprenorphine initiation rate was 14.4 per 100,000, only slightly lower than the rates from January 2019 through February 2020 and from January 2021 through October 2022 (15.5 per 100,000 and 15.0 per 100,000, respectively).

Over the entire study period from January 2016 through October 2022, the median monthly retention rate for buprenorphine use was 22.2%. This rate increased minimally, with no significant changes in slope and a monthly percentage change of 0.08% (P = .04).

The study findings were limited by several factors, including a lack of data on race and ethnicity, in-clinic administration of buprenorphine, and buprenorphine dispensing through methadone outpatient programs, the researchers note. Also, data did not indicate whether some patients began buprenorphine to treat pain, they say. The timing of the flattening of buprenorphine use also suggests the influence of factors beyond the COVID-19 pandemic, they write.

However, the results were strengthened by the large sample size and suggest that efforts to date to increase buprenorphine use have been unsuccessful, the researchers write. “A comprehensive approach is needed to eliminate barriers to buprenorphine initiation and retention, such as stigma and uneven access to prescribers,” they conclude.
 

Study highlights underuse of buprenorphine option

“Our study shows that buprenorphine initiation rates have been flat since the end of 2018 and that rates of 180-day retention in buprenorphine therapy have remained low throughout 2016-2022,” Dr. Chua told this news organization. “Neither of these findings are particularly surprising, but they are disappointing,” he said. “There were a lot of policy and clinical efforts to maintain and expand access to buprenorphine during the COVID-19 pandemic, such as allowing buprenorphine to be prescribed via telehealth without an in-person visit and eliminating training requirements for the waiver that previously was required to prescribe buprenorphine.

“The fact that buprenorphine initiation and retention did not rise after these efforts were implemented suggests that they were insufficient to meet the rising need for this medication,” he said.

The current study “adds to a growing body of research suggesting that clinicians are not maximizing opportunities to initiate buprenorphine treatment among patients with opioid addiction,” Dr. Chua said. He cited another of his recent studies in which 1 in 12 patients were prescribed buprenorphine within 30 days of an emergency department visit for opioid overdose from August 2019 to April 2021, but half of patients with emergency department visits with anaphylaxis were prescribed anepinephrine auto-injector.

“My hope is that our new study will further underscore to clinicians how much the health care system is underusing a critical tool to prevent opioid overdose deaths,” he said.

The federal government’s recent elimination of the waiver needed to prescribe buprenorphine may move the needle, but to what degree remains to be seen, Dr. Chua added. “It is possible this intervention will be insufficient to overcome the many other barriers to buprenorphine initiation and retention, such as stigma about the drug among clinicians, patients, and pharmacists,” he said.
 

Lack of education remains a barrier to buprenorphine use

The current study is important to determine whether attempts to increase buprenorphine initiation and treatment retention are working, said Reuben J. Strayer, MD, director of addiction medicine in the emergency medicine department at Maimonides Medical Center, New York, in an interview.

Dr. Strayer was not involved in the current study, but said he was surprised that initiation of buprenorphine didn’t decrease more dramatically during the pandemic, given the significant barriers to accessing care during that time.

However, “efforts to increase buprenorphine initiation and retention have not been sufficiently effective,” Dr. Strayer said. “The rise of fentanyl as a primary street opioid, replacing heroin, has dissuaded both patients and providers from initiating buprenorphine for fear of precipitated withdrawal.”

The elimination of the DATA 2000 (X) waiver was the removal of a potential barrier to increased buprenorphine use, said Dr. Strayer. “Now that the DATA 2000 (X) waiver has been eliminated, the focus of buprenorphine access is educating primary care and inpatient providers on its use, so that patients with OUD [opioid use disorder] can be treated, regardless of the venue at which they seek care,” he said.

Looking ahead, “The priority in buprenorphine research is determining the most effective way to initiate buprenorphine without the risk of precipitated withdrawal,” Dr. Strayer added.

The study was supported in part by the Benter Foundation, the Michigan Department of Health and Human Services, and the Susan B. Meister Child Health Evaluation and Research Center in the department of pediatrics at the University of Michigan. Dr. Chua was supported by the National Institute on Drug Abuse. Dr. Strayer has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Initiation of buprenorphine in hospitals in the United States has plateaued since 2018, with low retention rates of less than 25%, based on data from more than 3 million individuals who began buprenorphine between January 2016 and October 2022.

University of Michigan

Opioid overdose deaths are at a record high in the United States, and many of these deaths can be prevented with medications such as buprenorphine, said lead author Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, in an interview. “However, buprenorphine cannot prevent opioid overdose deaths if patients are never started on the medication or only stay on the medication for a short time. For that reason, rates of buprenorphine initiation and retention are critical metrics for measuring how well the U.S. health care system is responding to the opioid epidemic,” he said.

“At the time we started our study, several other research groups had evaluated U.S. rates of buprenorphine initiation and retention using data through 2020. However, more recent national data were lacking,” Dr. Chua told this news organization. “We felt that this was an important knowledge gap given the many changes in society that have occurred since 2020,” he noted. “For example, it was possible that the relaxation of social distancing measures during 2021 and 2022 might have reduced barriers to health care visits, thereby increasing opportunities to initiate treatment for opioid addiction with buprenorphine,” he said.

Dr. Chua and colleagues used data from the IQVIA Longitudinal Prescription Database, which reports 92% of prescriptions dispensed from retail pharmacies in the United States. “Buprenorphine products included immediate-release and extended-release formulations approved for opioid use disorder but not formulations primarily used to treat pain,” they write.

Monthly buprenorphine initiation was defined as the number of patients initiating therapy per 100,000 individuals. For retention, the researchers used a National Quality Forum-endorsed quality measure that defined retention as continuous use of buprenorphine for at least 180 days.

A total of 3,006,629 patients began buprenorphine therapy during the study period; approximately 43% were female.

During the first years of the study period, from January 2016 through September 2018, the monthly buprenorphine initiation rate increased from 12.5 per 100,000 to 15.9 per 100,000, with a statistically significant monthly percentage change of 0.62% (P < .001).

However, from October 2018 through October 2022, the monthly percentage remained essentially the same (P = .62) with a monthly percentage change of −0.03%.

From March 2020 through December 2020, the median monthly buprenorphine initiation rate was 14.4 per 100,000, only slightly lower than the rates from January 2019 through February 2020 and from January 2021 through October 2022 (15.5 per 100,000 and 15.0 per 100,000, respectively).

Over the entire study period from January 2016 through October 2022, the median monthly retention rate for buprenorphine use was 22.2%. This rate increased minimally, with no significant changes in slope and a monthly percentage change of 0.08% (P = .04).

The study findings were limited by several factors, including a lack of data on race and ethnicity, in-clinic administration of buprenorphine, and buprenorphine dispensing through methadone outpatient programs, the researchers note. Also, data did not indicate whether some patients began buprenorphine to treat pain, they say. The timing of the flattening of buprenorphine use also suggests the influence of factors beyond the COVID-19 pandemic, they write.

However, the results were strengthened by the large sample size and suggest that efforts to date to increase buprenorphine use have been unsuccessful, the researchers write. “A comprehensive approach is needed to eliminate barriers to buprenorphine initiation and retention, such as stigma and uneven access to prescribers,” they conclude.
 

Study highlights underuse of buprenorphine option

“Our study shows that buprenorphine initiation rates have been flat since the end of 2018 and that rates of 180-day retention in buprenorphine therapy have remained low throughout 2016-2022,” Dr. Chua told this news organization. “Neither of these findings are particularly surprising, but they are disappointing,” he said. “There were a lot of policy and clinical efforts to maintain and expand access to buprenorphine during the COVID-19 pandemic, such as allowing buprenorphine to be prescribed via telehealth without an in-person visit and eliminating training requirements for the waiver that previously was required to prescribe buprenorphine.

“The fact that buprenorphine initiation and retention did not rise after these efforts were implemented suggests that they were insufficient to meet the rising need for this medication,” he said.

The current study “adds to a growing body of research suggesting that clinicians are not maximizing opportunities to initiate buprenorphine treatment among patients with opioid addiction,” Dr. Chua said. He cited another of his recent studies in which 1 in 12 patients were prescribed buprenorphine within 30 days of an emergency department visit for opioid overdose from August 2019 to April 2021, but half of patients with emergency department visits with anaphylaxis were prescribed anepinephrine auto-injector.

“My hope is that our new study will further underscore to clinicians how much the health care system is underusing a critical tool to prevent opioid overdose deaths,” he said.

The federal government’s recent elimination of the waiver needed to prescribe buprenorphine may move the needle, but to what degree remains to be seen, Dr. Chua added. “It is possible this intervention will be insufficient to overcome the many other barriers to buprenorphine initiation and retention, such as stigma about the drug among clinicians, patients, and pharmacists,” he said.
 

Lack of education remains a barrier to buprenorphine use

The current study is important to determine whether attempts to increase buprenorphine initiation and treatment retention are working, said Reuben J. Strayer, MD, director of addiction medicine in the emergency medicine department at Maimonides Medical Center, New York, in an interview.

Dr. Strayer was not involved in the current study, but said he was surprised that initiation of buprenorphine didn’t decrease more dramatically during the pandemic, given the significant barriers to accessing care during that time.

However, “efforts to increase buprenorphine initiation and retention have not been sufficiently effective,” Dr. Strayer said. “The rise of fentanyl as a primary street opioid, replacing heroin, has dissuaded both patients and providers from initiating buprenorphine for fear of precipitated withdrawal.”

The elimination of the DATA 2000 (X) waiver was the removal of a potential barrier to increased buprenorphine use, said Dr. Strayer. “Now that the DATA 2000 (X) waiver has been eliminated, the focus of buprenorphine access is educating primary care and inpatient providers on its use, so that patients with OUD [opioid use disorder] can be treated, regardless of the venue at which they seek care,” he said.

Looking ahead, “The priority in buprenorphine research is determining the most effective way to initiate buprenorphine without the risk of precipitated withdrawal,” Dr. Strayer added.

The study was supported in part by the Benter Foundation, the Michigan Department of Health and Human Services, and the Susan B. Meister Child Health Evaluation and Research Center in the department of pediatrics at the University of Michigan. Dr. Chua was supported by the National Institute on Drug Abuse. Dr. Strayer has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Initiation of buprenorphine in hospitals in the United States has plateaued since 2018, with low retention rates of less than 25%, based on data from more than 3 million individuals who began buprenorphine between January 2016 and October 2022.

University of Michigan

Opioid overdose deaths are at a record high in the United States, and many of these deaths can be prevented with medications such as buprenorphine, said lead author Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, in an interview. “However, buprenorphine cannot prevent opioid overdose deaths if patients are never started on the medication or only stay on the medication for a short time. For that reason, rates of buprenorphine initiation and retention are critical metrics for measuring how well the U.S. health care system is responding to the opioid epidemic,” he said.

“At the time we started our study, several other research groups had evaluated U.S. rates of buprenorphine initiation and retention using data through 2020. However, more recent national data were lacking,” Dr. Chua told this news organization. “We felt that this was an important knowledge gap given the many changes in society that have occurred since 2020,” he noted. “For example, it was possible that the relaxation of social distancing measures during 2021 and 2022 might have reduced barriers to health care visits, thereby increasing opportunities to initiate treatment for opioid addiction with buprenorphine,” he said.

Dr. Chua and colleagues used data from the IQVIA Longitudinal Prescription Database, which reports 92% of prescriptions dispensed from retail pharmacies in the United States. “Buprenorphine products included immediate-release and extended-release formulations approved for opioid use disorder but not formulations primarily used to treat pain,” they write.

Monthly buprenorphine initiation was defined as the number of patients initiating therapy per 100,000 individuals. For retention, the researchers used a National Quality Forum-endorsed quality measure that defined retention as continuous use of buprenorphine for at least 180 days.

A total of 3,006,629 patients began buprenorphine therapy during the study period; approximately 43% were female.

During the first years of the study period, from January 2016 through September 2018, the monthly buprenorphine initiation rate increased from 12.5 per 100,000 to 15.9 per 100,000, with a statistically significant monthly percentage change of 0.62% (P < .001).

However, from October 2018 through October 2022, the monthly percentage remained essentially the same (P = .62) with a monthly percentage change of −0.03%.

From March 2020 through December 2020, the median monthly buprenorphine initiation rate was 14.4 per 100,000, only slightly lower than the rates from January 2019 through February 2020 and from January 2021 through October 2022 (15.5 per 100,000 and 15.0 per 100,000, respectively).

Over the entire study period from January 2016 through October 2022, the median monthly retention rate for buprenorphine use was 22.2%. This rate increased minimally, with no significant changes in slope and a monthly percentage change of 0.08% (P = .04).

The study findings were limited by several factors, including a lack of data on race and ethnicity, in-clinic administration of buprenorphine, and buprenorphine dispensing through methadone outpatient programs, the researchers note. Also, data did not indicate whether some patients began buprenorphine to treat pain, they say. The timing of the flattening of buprenorphine use also suggests the influence of factors beyond the COVID-19 pandemic, they write.

However, the results were strengthened by the large sample size and suggest that efforts to date to increase buprenorphine use have been unsuccessful, the researchers write. “A comprehensive approach is needed to eliminate barriers to buprenorphine initiation and retention, such as stigma and uneven access to prescribers,” they conclude.
 

Study highlights underuse of buprenorphine option

“Our study shows that buprenorphine initiation rates have been flat since the end of 2018 and that rates of 180-day retention in buprenorphine therapy have remained low throughout 2016-2022,” Dr. Chua told this news organization. “Neither of these findings are particularly surprising, but they are disappointing,” he said. “There were a lot of policy and clinical efforts to maintain and expand access to buprenorphine during the COVID-19 pandemic, such as allowing buprenorphine to be prescribed via telehealth without an in-person visit and eliminating training requirements for the waiver that previously was required to prescribe buprenorphine.

“The fact that buprenorphine initiation and retention did not rise after these efforts were implemented suggests that they were insufficient to meet the rising need for this medication,” he said.

The current study “adds to a growing body of research suggesting that clinicians are not maximizing opportunities to initiate buprenorphine treatment among patients with opioid addiction,” Dr. Chua said. He cited another of his recent studies in which 1 in 12 patients were prescribed buprenorphine within 30 days of an emergency department visit for opioid overdose from August 2019 to April 2021, but half of patients with emergency department visits with anaphylaxis were prescribed anepinephrine auto-injector.

“My hope is that our new study will further underscore to clinicians how much the health care system is underusing a critical tool to prevent opioid overdose deaths,” he said.

The federal government’s recent elimination of the waiver needed to prescribe buprenorphine may move the needle, but to what degree remains to be seen, Dr. Chua added. “It is possible this intervention will be insufficient to overcome the many other barriers to buprenorphine initiation and retention, such as stigma about the drug among clinicians, patients, and pharmacists,” he said.
 

Lack of education remains a barrier to buprenorphine use

The current study is important to determine whether attempts to increase buprenorphine initiation and treatment retention are working, said Reuben J. Strayer, MD, director of addiction medicine in the emergency medicine department at Maimonides Medical Center, New York, in an interview.

Dr. Strayer was not involved in the current study, but said he was surprised that initiation of buprenorphine didn’t decrease more dramatically during the pandemic, given the significant barriers to accessing care during that time.

However, “efforts to increase buprenorphine initiation and retention have not been sufficiently effective,” Dr. Strayer said. “The rise of fentanyl as a primary street opioid, replacing heroin, has dissuaded both patients and providers from initiating buprenorphine for fear of precipitated withdrawal.”

The elimination of the DATA 2000 (X) waiver was the removal of a potential barrier to increased buprenorphine use, said Dr. Strayer. “Now that the DATA 2000 (X) waiver has been eliminated, the focus of buprenorphine access is educating primary care and inpatient providers on its use, so that patients with OUD [opioid use disorder] can be treated, regardless of the venue at which they seek care,” he said.

Looking ahead, “The priority in buprenorphine research is determining the most effective way to initiate buprenorphine without the risk of precipitated withdrawal,” Dr. Strayer added.

The study was supported in part by the Benter Foundation, the Michigan Department of Health and Human Services, and the Susan B. Meister Child Health Evaluation and Research Center in the department of pediatrics at the University of Michigan. Dr. Chua was supported by the National Institute on Drug Abuse. Dr. Strayer has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Researchers have identified four distinct clinical profiles for young people at risk for serious self-harm. The profiles were developed from their study of children and adolescents aged 5-18 years who had been admitted with a neuropsychiatric event to two children’s hospitals.

The researchers used Bayesian regression to identify the profiles developed from 32 covariates: age, sex, and 30 mental health diagnostic groups from April 2016 to March 2020. The profiles include low-, moderate-, high- and very-high-risk categories.

The study, led by Mert Sekmen with the division of hospital medicine at Monroe Carell Jr. Children’s Hospital, and a student at Vanderbilt University Medical Center in Nashville, Tenn., included 1,098 children, average age 14. Of those, 406 (37%) were diagnosed with a self-harm event.

Traditionally, single diagnoses have been linked with risk of self-harm, independent of other comorbidities, but this study gauges risk for a set of diagnoses.

Findings were published online in Pediatrics.

The risk groups were described as follows:

• Low risk. (45% of the study population; median risk of 0.04 (interquartile range, 0.03-0.04; odds ratio, 0.08). The group included children aged 5-9 years with a non–mental health diagnosis, and without mood, behavioral, psychotic, developmental, trauma, or substance-related disorders.
• Moderate risk. (8% of the study group). This group had the same risk as the baseline risk for the entire cohort (37%) and served as the reference group, with a median risk of 0.30 (IQR, 0.27-0.33). This profile was characterized by several mood disorders and behavioral disorders but without depressive disorders.
• High risk. (36%) This group had an average risk of 0.69 (IQR, 0.67-0.71; OR, 5.09). This profile included female adolescents ages 14-17 with depression and anxiety in conjunction with substance- and trauma-related disorders. Personality and eating disorders were significant in this group. Importantly, the authors wrote, the high-risk group did not include behavioral and developmental disorders.
• Very high risk. (11%) The very-high-risk profile had the highest average risk of 0.79 (IQR, 0.73-0.79; OR, 7.21) and included male children aged 10-13. This profile, like the high-risk profile, included anxiety and depressive disorders. The very-high-risk profile differed from the high-risk with its inclusion of bipolar disorder; attention-deficit/hyperactivity disorder; and trauma-related and developmental disorders such as autism spectrum disorder or intellectual disability, along with conduct disorders. Neither the high- nor the very-high-risk profiles included a concurrent non–mental health diagnosis.

Differences by sex

The authors explained some of the differences by sex. They noted that in a study of children aged 5-11, deaths by suicide were more prevalent among boys. A mental health diagnosis was identified in 31%, the most common being ADHD, depression, and other unspecified co-occurring disorders.

“The very-high-risk group also reflects a concerning rise in death by suicide among (males) aged 10-13, who have seen rates nearly triple from 2007 to 2017,” the authors wrote.

The authors pointed out that, although incidence of anxiety and depressive disorders between male and female children is much the same before adolescence, “female adolescents are twice as likely to be diagnosed with either disorder during adolescence. Girls also have higher rates of suicidal ideation and attempts after puberty.”

Eating disorders were also included in the high-risk profile. A study showed that emergency department visits for adolescent girls attempting suicide were 51% higher from February to March 2021, compared with the same period in the pre-COVID-19 year 2019.

Jason Lewis, PhD, psychologist and section director of mood, anxiety and trauma disorders in the department of child and adolescent psychiatry and behavioral sciences at Children’s Hospital of Philadelphia, who was not part of the research team, said the “constellations of risk factors put into acuity levels” helps to better project risk than knowing the risk associated with a particular diagnosis.
 

Gap closing between young children, adolescents

Dr. Lewis said he was surprised by the young age of 10-13 among the boys in the highest-risk category. That speaks to the differences from standard thinking this paper points out, he said. “Generally, we think about adolescents as being at the highest risk of suicide death and suicidal behavior,” he said.

Dr. Lewis said it’s important to note that the authors acknowledge these profiles are not static. He gave an example that the rate of suicide deaths among females is rising.

“As things like that change, some of these risk profiles will change as well.”

Dr. Lewis said the profiles may be especially helpful to medical providers in emergency departments or those making discharge decisions who don’t have an ongoing relationship with a patient.

The information could also help educators and lay people, “think about suicide in the youth population in ways we don’t normally think about it,” Dr. Lewis said.

Covariates considered for profiles were determined through expert consensus between pediatric psychiatrists, general pediatricians, pediatric hospitalists, pediatric complex care physicians, and pediatric pharmacoepidemiologists.

Age was broken into three groups: 5-9 years, 10-13 years, and 14-17 years based on Centers for Disease Control and Prevention reporting and previous studies that showed significant increases in suicide rates in these age-based subgroups.
 

Results are preliminary

The authors note that the profiles were developed using data from 1,000 children with neuropsychiatric complaints at two academic children’s hospitals and are thus preliminary.

“Future studies should focus on validating these risk profiles in a larger, more heterogeneous population of children and adolescents,” the authors write.

They also acknowledge that they were not able to include factors such as medication use, previous suicidal behavior, and family and social support, which also factor into risk.

The study authors and Dr. Lewis report no relevant financial relationships.

Researchers have identified four distinct clinical profiles for young people at risk for serious self-harm. The profiles were developed from their study of children and adolescents aged 5-18 years who had been admitted with a neuropsychiatric event to two children’s hospitals.

The researchers used Bayesian regression to identify the profiles developed from 32 covariates: age, sex, and 30 mental health diagnostic groups from April 2016 to March 2020. The profiles include low-, moderate-, high- and very-high-risk categories.

The study, led by Mert Sekmen with the division of hospital medicine at Monroe Carell Jr. Children’s Hospital, and a student at Vanderbilt University Medical Center in Nashville, Tenn., included 1,098 children, average age 14. Of those, 406 (37%) were diagnosed with a self-harm event.

Traditionally, single diagnoses have been linked with risk of self-harm, independent of other comorbidities, but this study gauges risk for a set of diagnoses.

Findings were published online in Pediatrics.

The risk groups were described as follows:

• Low risk. (45% of the study population; median risk of 0.04 (interquartile range, 0.03-0.04; odds ratio, 0.08). The group included children aged 5-9 years with a non–mental health diagnosis, and without mood, behavioral, psychotic, developmental, trauma, or substance-related disorders.
• Moderate risk. (8% of the study group). This group had the same risk as the baseline risk for the entire cohort (37%) and served as the reference group, with a median risk of 0.30 (IQR, 0.27-0.33). This profile was characterized by several mood disorders and behavioral disorders but without depressive disorders.
• High risk. (36%) This group had an average risk of 0.69 (IQR, 0.67-0.71; OR, 5.09). This profile included female adolescents ages 14-17 with depression and anxiety in conjunction with substance- and trauma-related disorders. Personality and eating disorders were significant in this group. Importantly, the authors wrote, the high-risk group did not include behavioral and developmental disorders.
• Very high risk. (11%) The very-high-risk profile had the highest average risk of 0.79 (IQR, 0.73-0.79; OR, 7.21) and included male children aged 10-13. This profile, like the high-risk profile, included anxiety and depressive disorders. The very-high-risk profile differed from the high-risk with its inclusion of bipolar disorder; attention-deficit/hyperactivity disorder; and trauma-related and developmental disorders such as autism spectrum disorder or intellectual disability, along with conduct disorders. Neither the high- nor the very-high-risk profiles included a concurrent non–mental health diagnosis.

Differences by sex

The authors explained some of the differences by sex. They noted that in a study of children aged 5-11, deaths by suicide were more prevalent among boys. A mental health diagnosis was identified in 31%, the most common being ADHD, depression, and other unspecified co-occurring disorders.

“The very-high-risk group also reflects a concerning rise in death by suicide among (males) aged 10-13, who have seen rates nearly triple from 2007 to 2017,” the authors wrote.

The authors pointed out that, although incidence of anxiety and depressive disorders between male and female children is much the same before adolescence, “female adolescents are twice as likely to be diagnosed with either disorder during adolescence. Girls also have higher rates of suicidal ideation and attempts after puberty.”

Eating disorders were also included in the high-risk profile. A study showed that emergency department visits for adolescent girls attempting suicide were 51% higher from February to March 2021, compared with the same period in the pre-COVID-19 year 2019.

Jason Lewis, PhD, psychologist and section director of mood, anxiety and trauma disorders in the department of child and adolescent psychiatry and behavioral sciences at Children’s Hospital of Philadelphia, who was not part of the research team, said the “constellations of risk factors put into acuity levels” helps to better project risk than knowing the risk associated with a particular diagnosis.
 

Gap closing between young children, adolescents

Dr. Lewis said he was surprised by the young age of 10-13 among the boys in the highest-risk category. That speaks to the differences from standard thinking this paper points out, he said. “Generally, we think about adolescents as being at the highest risk of suicide death and suicidal behavior,” he said.

Dr. Lewis said it’s important to note that the authors acknowledge these profiles are not static. He gave an example that the rate of suicide deaths among females is rising.

“As things like that change, some of these risk profiles will change as well.”

Dr. Lewis said the profiles may be especially helpful to medical providers in emergency departments or those making discharge decisions who don’t have an ongoing relationship with a patient.

The information could also help educators and lay people, “think about suicide in the youth population in ways we don’t normally think about it,” Dr. Lewis said.

Covariates considered for profiles were determined through expert consensus between pediatric psychiatrists, general pediatricians, pediatric hospitalists, pediatric complex care physicians, and pediatric pharmacoepidemiologists.

Age was broken into three groups: 5-9 years, 10-13 years, and 14-17 years based on Centers for Disease Control and Prevention reporting and previous studies that showed significant increases in suicide rates in these age-based subgroups.
 

Results are preliminary

The authors note that the profiles were developed using data from 1,000 children with neuropsychiatric complaints at two academic children’s hospitals and are thus preliminary.

“Future studies should focus on validating these risk profiles in a larger, more heterogeneous population of children and adolescents,” the authors write.

They also acknowledge that they were not able to include factors such as medication use, previous suicidal behavior, and family and social support, which also factor into risk.

The study authors and Dr. Lewis report no relevant financial relationships.

Researchers have identified four distinct clinical profiles for young people at risk for serious self-harm. The profiles were developed from their study of children and adolescents aged 5-18 years who had been admitted with a neuropsychiatric event to two children’s hospitals.

The researchers used Bayesian regression to identify the profiles developed from 32 covariates: age, sex, and 30 mental health diagnostic groups from April 2016 to March 2020. The profiles include low-, moderate-, high- and very-high-risk categories.

The study, led by Mert Sekmen with the division of hospital medicine at Monroe Carell Jr. Children’s Hospital, and a student at Vanderbilt University Medical Center in Nashville, Tenn., included 1,098 children, average age 14. Of those, 406 (37%) were diagnosed with a self-harm event.

Traditionally, single diagnoses have been linked with risk of self-harm, independent of other comorbidities, but this study gauges risk for a set of diagnoses.

Findings were published online in Pediatrics.

The risk groups were described as follows:

• Low risk. (45% of the study population; median risk of 0.04 (interquartile range, 0.03-0.04; odds ratio, 0.08). The group included children aged 5-9 years with a non–mental health diagnosis, and without mood, behavioral, psychotic, developmental, trauma, or substance-related disorders.
• Moderate risk. (8% of the study group). This group had the same risk as the baseline risk for the entire cohort (37%) and served as the reference group, with a median risk of 0.30 (IQR, 0.27-0.33). This profile was characterized by several mood disorders and behavioral disorders but without depressive disorders.
• High risk. (36%) This group had an average risk of 0.69 (IQR, 0.67-0.71; OR, 5.09). This profile included female adolescents ages 14-17 with depression and anxiety in conjunction with substance- and trauma-related disorders. Personality and eating disorders were significant in this group. Importantly, the authors wrote, the high-risk group did not include behavioral and developmental disorders.
• Very high risk. (11%) The very-high-risk profile had the highest average risk of 0.79 (IQR, 0.73-0.79; OR, 7.21) and included male children aged 10-13. This profile, like the high-risk profile, included anxiety and depressive disorders. The very-high-risk profile differed from the high-risk with its inclusion of bipolar disorder; attention-deficit/hyperactivity disorder; and trauma-related and developmental disorders such as autism spectrum disorder or intellectual disability, along with conduct disorders. Neither the high- nor the very-high-risk profiles included a concurrent non–mental health diagnosis.

Differences by sex

The authors explained some of the differences by sex. They noted that in a study of children aged 5-11, deaths by suicide were more prevalent among boys. A mental health diagnosis was identified in 31%, the most common being ADHD, depression, and other unspecified co-occurring disorders.

“The very-high-risk group also reflects a concerning rise in death by suicide among (males) aged 10-13, who have seen rates nearly triple from 2007 to 2017,” the authors wrote.

The authors pointed out that, although incidence of anxiety and depressive disorders between male and female children is much the same before adolescence, “female adolescents are twice as likely to be diagnosed with either disorder during adolescence. Girls also have higher rates of suicidal ideation and attempts after puberty.”

Eating disorders were also included in the high-risk profile. A study showed that emergency department visits for adolescent girls attempting suicide were 51% higher from February to March 2021, compared with the same period in the pre-COVID-19 year 2019.

Jason Lewis, PhD, psychologist and section director of mood, anxiety and trauma disorders in the department of child and adolescent psychiatry and behavioral sciences at Children’s Hospital of Philadelphia, who was not part of the research team, said the “constellations of risk factors put into acuity levels” helps to better project risk than knowing the risk associated with a particular diagnosis.
 

Gap closing between young children, adolescents

Dr. Lewis said he was surprised by the young age of 10-13 among the boys in the highest-risk category. That speaks to the differences from standard thinking this paper points out, he said. “Generally, we think about adolescents as being at the highest risk of suicide death and suicidal behavior,” he said.

Dr. Lewis said it’s important to note that the authors acknowledge these profiles are not static. He gave an example that the rate of suicide deaths among females is rising.

“As things like that change, some of these risk profiles will change as well.”

Dr. Lewis said the profiles may be especially helpful to medical providers in emergency departments or those making discharge decisions who don’t have an ongoing relationship with a patient.

The information could also help educators and lay people, “think about suicide in the youth population in ways we don’t normally think about it,” Dr. Lewis said.

Covariates considered for profiles were determined through expert consensus between pediatric psychiatrists, general pediatricians, pediatric hospitalists, pediatric complex care physicians, and pediatric pharmacoepidemiologists.

Age was broken into three groups: 5-9 years, 10-13 years, and 14-17 years based on Centers for Disease Control and Prevention reporting and previous studies that showed significant increases in suicide rates in these age-based subgroups.
 

Results are preliminary

The authors note that the profiles were developed using data from 1,000 children with neuropsychiatric complaints at two academic children’s hospitals and are thus preliminary.

“Future studies should focus on validating these risk profiles in a larger, more heterogeneous population of children and adolescents,” the authors write.

They also acknowledge that they were not able to include factors such as medication use, previous suicidal behavior, and family and social support, which also factor into risk.

The study authors and Dr. Lewis report no relevant financial relationships.

WASHINGTON – A novel program for parents of highly dependent adult children reduces parental burden and anxiety in their offspring, a new pilot study shows.

Known as failure to launch (FTL) syndrome, the criteria for this condition include the absence of a neurodevelopmental, mental, or intellectual condition, difficulty adapting to the challenges of adulthood, and living with or at the expense of parents.

Results suggest that the program benefits families dealing with FTL, said study investigator Uri Berger, PhD, postdoctoral associate, Yale Child Study Center Anxiety and Mood Disorders Program, New Haven, Conn.

“If you encounter parents who are say 50-60 years old who have a child with FTL, you can tell them there’s something they can do; there’s work they can do even if their child is refusing to go to therapy,” he said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Anxious, isolated

Estimates suggest that there are 3.3 million physically able adults with FTL and that the disorder may be on the rise. These individuals often present with mental health symptoms including anxiety, depression, and suicidality, and tend to be socially isolated.

The investigators noted that intervening is often challenging because individuals with the syndrome are frequently noncompliant with therapy, and currently there is no standard of care.

“The longer you’re isolated, the harder it is getting out of your cocoon, and when these adult children get to the point where they seek help, they’re less likely to comply,” he said. However, he noted, this is not because they are lazy; it’s that they’re “very, very anxious.”

Parents and other family members are also negatively affected. Dr. Berger noted that 15% of parents of a child with FTL equate their caregiver burden with having a family member with a chronic physical illness. “It’s huge; parents go through hell and it’s very hard on them. Many believe it is their fault and they feel a lot of shame.”

Supportive Parenting for Anxious Childhood Emotions (SPACE) is a manualized, parent-based program for childhood anxiety and obsessive-compulsive disorder. It has been tested in clinical trials and found to be noninferior to cognitive behavioral therapy for childhood anxiety.

The research adapted it to treat FTL. SPACE-FTL focuses on reducing parents’ family accommodation (FA), a descriptor for a child’s excessive dependence on their parents to help them avoid anxiety-provoking situations.

The study examined the feasibility, acceptability, and treatment satisfaction and its effect on adult child psychopathology symptoms, parents’ FA, and the paternal burden of caring for adult children.

The study included parents (mean age, 59.46 years; 85% female) of 40 adult children with FTL (mean age, 23.51 years; 20% female) from across the United States.

Parents were randomized to a 13-week wait-list or the SPACE-FTL program, which involves 13-20 therapy sessions, depending on the need. The average number of sessions in the study was 15. The program has five key components:

• Providing information emphasizing FTL as not a character flaw but a problem with anxiety.
• Helping parents identify how they accommodate their child’s behavior, and facilitating an environment that encourages independence.
• Getting parents to show acceptance and confidence in their child who’s trying to overcome anxiety when, for example, they seek employment, instead of being overprotective and demanding.
• Focusing on change nonconfrontationally.
• Involving other family, community members, and professionals who can support the parent, child, or both.

The recruitment, treatment sessions, and assessments were all done online. Most participants rated the intervention as highly satisfactory on the Client Satisfaction Questionnaire (CSQ-8; mean score, 27.7 out of a maximum of 32). About 60% of the offspring no longer met full criteria for FTL (P < .001; Cohen’s D = 1.76).

All children of the wait-listed parents still met criteria for FTL.

FTL symptoms decreased significantly in the offspring of the intervention group, as seen in both in the Adult Entitled Dependence Scale (AED; P < .05; Cohen’s D = 0.84); and the Adaptive Behaviors Scale (ABS; P < .05; Cohen’s D = 0.70).

There was no change in anxiety as assessed by the Adult Behavior Checklist (ABCL). But Dr. Berger noted that child anxiety is difficult to assess through parental report.

“This population is self-isolating and parents sometimes don’t know what’s going on,” and ABCL measures may not be “as sensitive as we would have liked them to be,” Dr. Berger said.

Parental burden was significantly decreased as measured by the Zarit Burden Interview (ZBI; P < .05; Cohen’s D = 0.70). In addition, family accommodation decreased significantly as determined by the Family Accommodation Scale–Anxiety (FASA; P < .05; Cohen’s D = 0.70).
 

Innovative work

In a comment, Jonathan E. Alpert, MD, PhD, chair, department of psychiatry and behavioral sciences, and professor of psychiatry, neuroscience, and pediatrics, Albert Einstein College of Medicine, New York, described the program as “innovative.”

He noted that the SPACE-FTL approach provides parents with education and skills to reduce behaviors that reinforce their child’s avoidance of independent activities. Such behaviors “may inadvertently contribute to the adult child remaining stuck,” he said.

“Through its involvement of parents and use of a structured approach, SPACE-FTL is a very interesting step toward more evidence-based therapies.”

However, he noted that the number of study participants is still “very low” and further work is needed to better characterize this condition and develop effective therapies.

He noted that parents of adult children with FTL should not be judged or blamed. “They have been living with a worrisome problem for years and are simply doing their best to cope as any of us would do.”

In addition, he noted that some adult children aren’t capable of launching because of a serious mental illness or substance use disorder that needs treatment.

It’s unclear just how many adult children have FTL, as the condition lacks formal, agreed-upon clinical and research criteria and a reliable evidence base for treatment, Dr. Alpert said.

“Whatever the actual numbers of FTL, my anecdotal clinical experience suggests that it is a very common problem which is understudied.”

He added that the definitions of FTL should include cultural context. In some groups, it’s quite normal for adults in their 20s, 30s, or even older to live with their parents, Dr. Alpert said.

Dr. Berger and Dr. Albert report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

WASHINGTON – A novel program for parents of highly dependent adult children reduces parental burden and anxiety in their offspring, a new pilot study shows.

Known as failure to launch (FTL) syndrome, the criteria for this condition include the absence of a neurodevelopmental, mental, or intellectual condition, difficulty adapting to the challenges of adulthood, and living with or at the expense of parents.

Results suggest that the program benefits families dealing with FTL, said study investigator Uri Berger, PhD, postdoctoral associate, Yale Child Study Center Anxiety and Mood Disorders Program, New Haven, Conn.

“If you encounter parents who are say 50-60 years old who have a child with FTL, you can tell them there’s something they can do; there’s work they can do even if their child is refusing to go to therapy,” he said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Anxious, isolated

Estimates suggest that there are 3.3 million physically able adults with FTL and that the disorder may be on the rise. These individuals often present with mental health symptoms including anxiety, depression, and suicidality, and tend to be socially isolated.

The investigators noted that intervening is often challenging because individuals with the syndrome are frequently noncompliant with therapy, and currently there is no standard of care.

“The longer you’re isolated, the harder it is getting out of your cocoon, and when these adult children get to the point where they seek help, they’re less likely to comply,” he said. However, he noted, this is not because they are lazy; it’s that they’re “very, very anxious.”

Parents and other family members are also negatively affected. Dr. Berger noted that 15% of parents of a child with FTL equate their caregiver burden with having a family member with a chronic physical illness. “It’s huge; parents go through hell and it’s very hard on them. Many believe it is their fault and they feel a lot of shame.”

Supportive Parenting for Anxious Childhood Emotions (SPACE) is a manualized, parent-based program for childhood anxiety and obsessive-compulsive disorder. It has been tested in clinical trials and found to be noninferior to cognitive behavioral therapy for childhood anxiety.

The research adapted it to treat FTL. SPACE-FTL focuses on reducing parents’ family accommodation (FA), a descriptor for a child’s excessive dependence on their parents to help them avoid anxiety-provoking situations.

The study examined the feasibility, acceptability, and treatment satisfaction and its effect on adult child psychopathology symptoms, parents’ FA, and the paternal burden of caring for adult children.

The study included parents (mean age, 59.46 years; 85% female) of 40 adult children with FTL (mean age, 23.51 years; 20% female) from across the United States.

Parents were randomized to a 13-week wait-list or the SPACE-FTL program, which involves 13-20 therapy sessions, depending on the need. The average number of sessions in the study was 15. The program has five key components:

• Providing information emphasizing FTL as not a character flaw but a problem with anxiety.
• Helping parents identify how they accommodate their child’s behavior, and facilitating an environment that encourages independence.
• Getting parents to show acceptance and confidence in their child who’s trying to overcome anxiety when, for example, they seek employment, instead of being overprotective and demanding.
• Focusing on change nonconfrontationally.
• Involving other family, community members, and professionals who can support the parent, child, or both.

The recruitment, treatment sessions, and assessments were all done online. Most participants rated the intervention as highly satisfactory on the Client Satisfaction Questionnaire (CSQ-8; mean score, 27.7 out of a maximum of 32). About 60% of the offspring no longer met full criteria for FTL (P < .001; Cohen’s D = 1.76).

All children of the wait-listed parents still met criteria for FTL.

FTL symptoms decreased significantly in the offspring of the intervention group, as seen in both in the Adult Entitled Dependence Scale (AED; P < .05; Cohen’s D = 0.84); and the Adaptive Behaviors Scale (ABS; P < .05; Cohen’s D = 0.70).

There was no change in anxiety as assessed by the Adult Behavior Checklist (ABCL). But Dr. Berger noted that child anxiety is difficult to assess through parental report.

“This population is self-isolating and parents sometimes don’t know what’s going on,” and ABCL measures may not be “as sensitive as we would have liked them to be,” Dr. Berger said.

Parental burden was significantly decreased as measured by the Zarit Burden Interview (ZBI; P < .05; Cohen’s D = 0.70). In addition, family accommodation decreased significantly as determined by the Family Accommodation Scale–Anxiety (FASA; P < .05; Cohen’s D = 0.70).
 

Innovative work

In a comment, Jonathan E. Alpert, MD, PhD, chair, department of psychiatry and behavioral sciences, and professor of psychiatry, neuroscience, and pediatrics, Albert Einstein College of Medicine, New York, described the program as “innovative.”

He noted that the SPACE-FTL approach provides parents with education and skills to reduce behaviors that reinforce their child’s avoidance of independent activities. Such behaviors “may inadvertently contribute to the adult child remaining stuck,” he said.

“Through its involvement of parents and use of a structured approach, SPACE-FTL is a very interesting step toward more evidence-based therapies.”

However, he noted that the number of study participants is still “very low” and further work is needed to better characterize this condition and develop effective therapies.

He noted that parents of adult children with FTL should not be judged or blamed. “They have been living with a worrisome problem for years and are simply doing their best to cope as any of us would do.”

In addition, he noted that some adult children aren’t capable of launching because of a serious mental illness or substance use disorder that needs treatment.

It’s unclear just how many adult children have FTL, as the condition lacks formal, agreed-upon clinical and research criteria and a reliable evidence base for treatment, Dr. Alpert said.

“Whatever the actual numbers of FTL, my anecdotal clinical experience suggests that it is a very common problem which is understudied.”

He added that the definitions of FTL should include cultural context. In some groups, it’s quite normal for adults in their 20s, 30s, or even older to live with their parents, Dr. Alpert said.

Dr. Berger and Dr. Albert report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

WASHINGTON – A novel program for parents of highly dependent adult children reduces parental burden and anxiety in their offspring, a new pilot study shows.

Known as failure to launch (FTL) syndrome, the criteria for this condition include the absence of a neurodevelopmental, mental, or intellectual condition, difficulty adapting to the challenges of adulthood, and living with or at the expense of parents.

Results suggest that the program benefits families dealing with FTL, said study investigator Uri Berger, PhD, postdoctoral associate, Yale Child Study Center Anxiety and Mood Disorders Program, New Haven, Conn.

“If you encounter parents who are say 50-60 years old who have a child with FTL, you can tell them there’s something they can do; there’s work they can do even if their child is refusing to go to therapy,” he said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Anxious, isolated

Estimates suggest that there are 3.3 million physically able adults with FTL and that the disorder may be on the rise. These individuals often present with mental health symptoms including anxiety, depression, and suicidality, and tend to be socially isolated.

The investigators noted that intervening is often challenging because individuals with the syndrome are frequently noncompliant with therapy, and currently there is no standard of care.

“The longer you’re isolated, the harder it is getting out of your cocoon, and when these adult children get to the point where they seek help, they’re less likely to comply,” he said. However, he noted, this is not because they are lazy; it’s that they’re “very, very anxious.”

Parents and other family members are also negatively affected. Dr. Berger noted that 15% of parents of a child with FTL equate their caregiver burden with having a family member with a chronic physical illness. “It’s huge; parents go through hell and it’s very hard on them. Many believe it is their fault and they feel a lot of shame.”

Supportive Parenting for Anxious Childhood Emotions (SPACE) is a manualized, parent-based program for childhood anxiety and obsessive-compulsive disorder. It has been tested in clinical trials and found to be noninferior to cognitive behavioral therapy for childhood anxiety.

The research adapted it to treat FTL. SPACE-FTL focuses on reducing parents’ family accommodation (FA), a descriptor for a child’s excessive dependence on their parents to help them avoid anxiety-provoking situations.

The study examined the feasibility, acceptability, and treatment satisfaction and its effect on adult child psychopathology symptoms, parents’ FA, and the paternal burden of caring for adult children.

The study included parents (mean age, 59.46 years; 85% female) of 40 adult children with FTL (mean age, 23.51 years; 20% female) from across the United States.

Parents were randomized to a 13-week wait-list or the SPACE-FTL program, which involves 13-20 therapy sessions, depending on the need. The average number of sessions in the study was 15. The program has five key components:

• Providing information emphasizing FTL as not a character flaw but a problem with anxiety.
• Helping parents identify how they accommodate their child’s behavior, and facilitating an environment that encourages independence.
• Getting parents to show acceptance and confidence in their child who’s trying to overcome anxiety when, for example, they seek employment, instead of being overprotective and demanding.
• Focusing on change nonconfrontationally.
• Involving other family, community members, and professionals who can support the parent, child, or both.

The recruitment, treatment sessions, and assessments were all done online. Most participants rated the intervention as highly satisfactory on the Client Satisfaction Questionnaire (CSQ-8; mean score, 27.7 out of a maximum of 32). About 60% of the offspring no longer met full criteria for FTL (P < .001; Cohen’s D = 1.76).

All children of the wait-listed parents still met criteria for FTL.

FTL symptoms decreased significantly in the offspring of the intervention group, as seen in both in the Adult Entitled Dependence Scale (AED; P < .05; Cohen’s D = 0.84); and the Adaptive Behaviors Scale (ABS; P < .05; Cohen’s D = 0.70).

There was no change in anxiety as assessed by the Adult Behavior Checklist (ABCL). But Dr. Berger noted that child anxiety is difficult to assess through parental report.

“This population is self-isolating and parents sometimes don’t know what’s going on,” and ABCL measures may not be “as sensitive as we would have liked them to be,” Dr. Berger said.

Parental burden was significantly decreased as measured by the Zarit Burden Interview (ZBI; P < .05; Cohen’s D = 0.70). In addition, family accommodation decreased significantly as determined by the Family Accommodation Scale–Anxiety (FASA; P < .05; Cohen’s D = 0.70).
 

Innovative work

In a comment, Jonathan E. Alpert, MD, PhD, chair, department of psychiatry and behavioral sciences, and professor of psychiatry, neuroscience, and pediatrics, Albert Einstein College of Medicine, New York, described the program as “innovative.”

He noted that the SPACE-FTL approach provides parents with education and skills to reduce behaviors that reinforce their child’s avoidance of independent activities. Such behaviors “may inadvertently contribute to the adult child remaining stuck,” he said.

“Through its involvement of parents and use of a structured approach, SPACE-FTL is a very interesting step toward more evidence-based therapies.”

However, he noted that the number of study participants is still “very low” and further work is needed to better characterize this condition and develop effective therapies.

He noted that parents of adult children with FTL should not be judged or blamed. “They have been living with a worrisome problem for years and are simply doing their best to cope as any of us would do.”

In addition, he noted that some adult children aren’t capable of launching because of a serious mental illness or substance use disorder that needs treatment.

It’s unclear just how many adult children have FTL, as the condition lacks formal, agreed-upon clinical and research criteria and a reliable evidence base for treatment, Dr. Alpert said.

“Whatever the actual numbers of FTL, my anecdotal clinical experience suggests that it is a very common problem which is understudied.”

He added that the definitions of FTL should include cultural context. In some groups, it’s quite normal for adults in their 20s, 30s, or even older to live with their parents, Dr. Alpert said.

Dr. Berger and Dr. Albert report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Erratic sleep patterns, dysregulated transitions between sleep and wake cycles, and excessive sleep during the day are linked to a worsening of schizophrenia symptoms, new research shows.

University of Pittsburgh

The findings also showed that people with schizophrenia spectrum disorders (SSDs) who lived in residential facilities experienced rigid routines, which correlated with a higher degree of negative symptoms.

The rigid routines were problematic for the patients living in residential settings, lead investigator Fabio Ferrarelli, MD, PhD, told this news organization. Dr. Ferrarelli is an associate professor of psychiatry at the University of Pittsburgh.

“Engaging in different activities at different times in activities associated with motivation and social interaction – this helps to ameliorate difficult-to-treat negative symptoms,” he said.

The findings were published online in Molecular Psychiatry.


 

Need to increase activity levels

While there is no shortage of research on sleep disturbances among people with schizophrenia, research focusing specifically on rest-activity rhythm disturbances and their relationships to symptoms of schizophrenia has been limited by small sample sizes or the lack of a control group, the investigators note.

To address this research gap, the investigators recruited 230 patients with SSD from participating residential facilities and communities throughout Italy. The participants included 108 healthy control participants, 54 community-dwelling patients with SSD who were receiving outpatient services, and 68 patients with SSD who were living in residential facilities.

All participants wore an actigraph for 7 consecutive days so that investigators could monitor sleep-wake patterns.

Compared with healthy control participants, both SSD groups had more total sleep time and spent more time resting or being passive (P < .001). In contrast, healthy control participants were much more active.

Part of the explanation for this may be that most of the control participants had jobs or attended school. In addition, the investigators note that many medications used to treat SSD can be highly sedating, causing some patients to sleep up to 15 hours per day.

Among residential participants with SSD, there was a higher level of inter-daily stability and higher daily rest-activity-rest fragmentation than occurred among healthy control participants or community-dwelling patients with SSD (P < .001). There was also a higher level of negative symptoms among residential participants with SSD than among the community-dwelling group with SSD.

When the findings were taken together, Dr. Ferrarelli and his team interpreted them to mean that inter-daily stability could reflect premature aging or neurodegenerative processes in patients with more severe forms of schizophrenia.

Another explanation could be that the rigid routine of the residential facility was making negative symptoms worse, Dr. Ferrarelli said. It is important to add variety into the mix – getting people to engage in different activities at different times of day would likely help residential SSD patients overcome negative symptoms of the disorder.

Although participants were recruited in Italy, Dr. Ferrarelli said he believes the findings are generalizable.
 

Bidirectional relationship?

Commenting on the findings, Matcheri Keshavan, MD, professor of psychiatry at Harvard Medical School in Boston, said the results are consistent with “well-known clinical observations that SSD patients tend to spend more time in bed and have more dysregulated sleep.

Harvard Medical School

“Negative symptoms are also common, especially in residential patients. However, it is difficult to determine causality, as we do not know whether excessive sleepiness and decreased physical activity cause negative symptoms, or vice versa, or whether this is a bidirectional relationship,” Dr. Keshavan said.

He emphasized that physical exercise is known to increase sleep quality for people with mental illness and may also improve negative symptoms. “A useful approach in clinical practice is to increase activity levels, especially physical activities like walking and gardening.”

Dr. Keshavan said he would like to see future research that focuses on whether an intervention such as aerobic exercise would improve sleep quality as well as negative symptoms.

He also said that future research should ideally examine the characteristics of sleep alterations in schizophrenia.

“For example, while sleep duration is increased in schizophrenia, studies suggest that time spent in deep sleep is reduced; sleep spindles, which are important for consolidating memory during sleep, are also reduced. Correcting these deficits may improve negative symptoms and cognitive deficits,” he added.

The study was funded by the Italian Ministry of Health and the National Institute of Mental Health. There were no conflicts of interest.

A version of this article first appeared on Medscape.com.

Erratic sleep patterns, dysregulated transitions between sleep and wake cycles, and excessive sleep during the day are linked to a worsening of schizophrenia symptoms, new research shows.

University of Pittsburgh

The findings also showed that people with schizophrenia spectrum disorders (SSDs) who lived in residential facilities experienced rigid routines, which correlated with a higher degree of negative symptoms.

The rigid routines were problematic for the patients living in residential settings, lead investigator Fabio Ferrarelli, MD, PhD, told this news organization. Dr. Ferrarelli is an associate professor of psychiatry at the University of Pittsburgh.

“Engaging in different activities at different times in activities associated with motivation and social interaction – this helps to ameliorate difficult-to-treat negative symptoms,” he said.

The findings were published online in Molecular Psychiatry.


 

Need to increase activity levels

While there is no shortage of research on sleep disturbances among people with schizophrenia, research focusing specifically on rest-activity rhythm disturbances and their relationships to symptoms of schizophrenia has been limited by small sample sizes or the lack of a control group, the investigators note.

To address this research gap, the investigators recruited 230 patients with SSD from participating residential facilities and communities throughout Italy. The participants included 108 healthy control participants, 54 community-dwelling patients with SSD who were receiving outpatient services, and 68 patients with SSD who were living in residential facilities.

All participants wore an actigraph for 7 consecutive days so that investigators could monitor sleep-wake patterns.

Compared with healthy control participants, both SSD groups had more total sleep time and spent more time resting or being passive (P < .001). In contrast, healthy control participants were much more active.

Part of the explanation for this may be that most of the control participants had jobs or attended school. In addition, the investigators note that many medications used to treat SSD can be highly sedating, causing some patients to sleep up to 15 hours per day.

Among residential participants with SSD, there was a higher level of inter-daily stability and higher daily rest-activity-rest fragmentation than occurred among healthy control participants or community-dwelling patients with SSD (P < .001). There was also a higher level of negative symptoms among residential participants with SSD than among the community-dwelling group with SSD.

When the findings were taken together, Dr. Ferrarelli and his team interpreted them to mean that inter-daily stability could reflect premature aging or neurodegenerative processes in patients with more severe forms of schizophrenia.

Another explanation could be that the rigid routine of the residential facility was making negative symptoms worse, Dr. Ferrarelli said. It is important to add variety into the mix – getting people to engage in different activities at different times of day would likely help residential SSD patients overcome negative symptoms of the disorder.

Although participants were recruited in Italy, Dr. Ferrarelli said he believes the findings are generalizable.
 

Bidirectional relationship?

Commenting on the findings, Matcheri Keshavan, MD, professor of psychiatry at Harvard Medical School in Boston, said the results are consistent with “well-known clinical observations that SSD patients tend to spend more time in bed and have more dysregulated sleep.

Harvard Medical School

“Negative symptoms are also common, especially in residential patients. However, it is difficult to determine causality, as we do not know whether excessive sleepiness and decreased physical activity cause negative symptoms, or vice versa, or whether this is a bidirectional relationship,” Dr. Keshavan said.

He emphasized that physical exercise is known to increase sleep quality for people with mental illness and may also improve negative symptoms. “A useful approach in clinical practice is to increase activity levels, especially physical activities like walking and gardening.”

Dr. Keshavan said he would like to see future research that focuses on whether an intervention such as aerobic exercise would improve sleep quality as well as negative symptoms.

He also said that future research should ideally examine the characteristics of sleep alterations in schizophrenia.

“For example, while sleep duration is increased in schizophrenia, studies suggest that time spent in deep sleep is reduced; sleep spindles, which are important for consolidating memory during sleep, are also reduced. Correcting these deficits may improve negative symptoms and cognitive deficits,” he added.

The study was funded by the Italian Ministry of Health and the National Institute of Mental Health. There were no conflicts of interest.

A version of this article first appeared on Medscape.com.

Erratic sleep patterns, dysregulated transitions between sleep and wake cycles, and excessive sleep during the day are linked to a worsening of schizophrenia symptoms, new research shows.

University of Pittsburgh

The findings also showed that people with schizophrenia spectrum disorders (SSDs) who lived in residential facilities experienced rigid routines, which correlated with a higher degree of negative symptoms.

The rigid routines were problematic for the patients living in residential settings, lead investigator Fabio Ferrarelli, MD, PhD, told this news organization. Dr. Ferrarelli is an associate professor of psychiatry at the University of Pittsburgh.

“Engaging in different activities at different times in activities associated with motivation and social interaction – this helps to ameliorate difficult-to-treat negative symptoms,” he said.

The findings were published online in Molecular Psychiatry.


 

Need to increase activity levels

While there is no shortage of research on sleep disturbances among people with schizophrenia, research focusing specifically on rest-activity rhythm disturbances and their relationships to symptoms of schizophrenia has been limited by small sample sizes or the lack of a control group, the investigators note.

To address this research gap, the investigators recruited 230 patients with SSD from participating residential facilities and communities throughout Italy. The participants included 108 healthy control participants, 54 community-dwelling patients with SSD who were receiving outpatient services, and 68 patients with SSD who were living in residential facilities.

All participants wore an actigraph for 7 consecutive days so that investigators could monitor sleep-wake patterns.

Compared with healthy control participants, both SSD groups had more total sleep time and spent more time resting or being passive (P < .001). In contrast, healthy control participants were much more active.

Part of the explanation for this may be that most of the control participants had jobs or attended school. In addition, the investigators note that many medications used to treat SSD can be highly sedating, causing some patients to sleep up to 15 hours per day.

Among residential participants with SSD, there was a higher level of inter-daily stability and higher daily rest-activity-rest fragmentation than occurred among healthy control participants or community-dwelling patients with SSD (P < .001). There was also a higher level of negative symptoms among residential participants with SSD than among the community-dwelling group with SSD.

When the findings were taken together, Dr. Ferrarelli and his team interpreted them to mean that inter-daily stability could reflect premature aging or neurodegenerative processes in patients with more severe forms of schizophrenia.

Another explanation could be that the rigid routine of the residential facility was making negative symptoms worse, Dr. Ferrarelli said. It is important to add variety into the mix – getting people to engage in different activities at different times of day would likely help residential SSD patients overcome negative symptoms of the disorder.

Although participants were recruited in Italy, Dr. Ferrarelli said he believes the findings are generalizable.
 

Bidirectional relationship?

Commenting on the findings, Matcheri Keshavan, MD, professor of psychiatry at Harvard Medical School in Boston, said the results are consistent with “well-known clinical observations that SSD patients tend to spend more time in bed and have more dysregulated sleep.

Harvard Medical School

“Negative symptoms are also common, especially in residential patients. However, it is difficult to determine causality, as we do not know whether excessive sleepiness and decreased physical activity cause negative symptoms, or vice versa, or whether this is a bidirectional relationship,” Dr. Keshavan said.

He emphasized that physical exercise is known to increase sleep quality for people with mental illness and may also improve negative symptoms. “A useful approach in clinical practice is to increase activity levels, especially physical activities like walking and gardening.”

Dr. Keshavan said he would like to see future research that focuses on whether an intervention such as aerobic exercise would improve sleep quality as well as negative symptoms.

He also said that future research should ideally examine the characteristics of sleep alterations in schizophrenia.

“For example, while sleep duration is increased in schizophrenia, studies suggest that time spent in deep sleep is reduced; sleep spindles, which are important for consolidating memory during sleep, are also reduced. Correcting these deficits may improve negative symptoms and cognitive deficits,” he added.

The study was funded by the Italian Ministry of Health and the National Institute of Mental Health. There were no conflicts of interest.

A version of this article first appeared on Medscape.com.

WASHINGTON –  Posttraumatic stress disorder (PTSD) is strongly linked to disordered eating, which in turn, impedes treatment for the anxiety disorder in new findings that underscore the need for better screening of eating disorder impairment (EDI).

“Eating-related and body-image concerns may be more prevalent than we think, and if not considered, these concerns can make psychotherapy treatment less effective,” study author Nick Powers, a doctoral student in clinical psychology, La Salle University, Philadelphia, told this news organization.

Nick Powers

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Common bedfellows

Although many patients with PTSD also have an eating disorder, they are not always properly assessed for eating pathology and related functional impairment.

Some therapists don’t feel adequately equipped to target eating-related concerns in these patients and so may refer them to other providers. This, said Mr. Powers, can prolong symptoms and further distress patients.

Mr. Powers noted childhood physical or sexual abuse may affect eating patterns in patients with PTSD. “The evidence suggests these types of trauma exposure can be risk factors for the development of an eating disorder.”

Undiagnosed eating pathology may exacerbate functional impairment from PTSD and weaken the impact of evidence-based treatment.

Such patients are challenging to treat as they may not have the requisite skills to fully engage in exposure therapy, an evidence-based approach to treat PTSD, said Mr. Powers.

To determine whether PTSD would be significantly linked to greater eating disorder impairment (EDI) compared with other anxiety-related diagnoses and whether this would impair treatment, investigators studied 748 patients with an anxiety disorder who were attending a cognitive behavioral therapy (CBT) clinic. Anxiety disorders included PTSD, obsessive-compulsive disorder (OCD), social anxiety, and panic disorder.

Participants completed the 16-item Clinical Impairment Assessment (CIA) questionnaire, which includes questions about eating habits and feelings about food, body shape, and weight over the previous 4 weeks. Participants also reported anxiety symptom severity at the beginning, during, and end of treatment.
 

Need for better screening

Results showed that compared with those who had other anxiety disorders, patients with PTSD were three times more likely to have disordered eating (odds ratio [OR], 3.06; 95% confidence interval [CI], 1.47-6.37; P = .003).

In addition, higher baseline CIA scores predicted poorer PTSD treatment outcome (beta = –1.4; 95% CI, –1.67 to –1.10; P < .01).

“Having higher baseline CIA scores meant that patients’ PTSD symptoms did not remit as strongly compared to those with lower scores,” said Mr. Powers.

Patients with both PTSD and an eating disorder may have difficulty with regulating emotions and tolerating distress, he said.

“They may use binge eating, purging, or food restriction as strategies to regulate emotions. These behaviors may allow patients to become numb to or avoid heightened emotions that come from having PTSD and an eating disorder.”

Prior research linked perfectionism tendencies to poorer response to PTSD treatment. Those with an eating disorder may share similar tendencies, said Mr. Powers.

“If someone is consistently thinking negatively about their eating or body to the point where it interrupts their functioning, they may not be as likely to fully engage with PTSD treatment,” he said.

Ideally, clinicians would screen all patients with PTSD for an eating disorder, said Mr. Powers. “If screening instruments aren’t feasible or available, even just inquiring about body image or history of maladaptive eating behaviors can be helpful.”

He added this could open up a conversation about a traumatic event in the patient’s past.
 

Confirmatory research

Commenting on the study, Karen S. Mitchell, PhD, clinical research psychologist, National Center for PTSD, VA Boston Healthcare System, and associate professor in psychiatry, Boston University, said she was “excited” to see this research.

Boston University

“Very few studies have examined the impact of baseline eating disorder symptoms on PTSD treatment outcomes or vice versa,” she said.

The study findings “add to the small but growing body of evidence suggesting that comorbid PTSD and eating disorder symptoms can impact recovery from each disorder,” she said.

She noted the importance of assessing comorbidity in patients presenting for treatment and of addressing comorbidity in both eating disorders and PTSD treatment. “But we need more research on how best to do this.”

Mr. Powers and Dr. Mitchell have reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

WASHINGTON –  Posttraumatic stress disorder (PTSD) is strongly linked to disordered eating, which in turn, impedes treatment for the anxiety disorder in new findings that underscore the need for better screening of eating disorder impairment (EDI).

“Eating-related and body-image concerns may be more prevalent than we think, and if not considered, these concerns can make psychotherapy treatment less effective,” study author Nick Powers, a doctoral student in clinical psychology, La Salle University, Philadelphia, told this news organization.

Nick Powers

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Common bedfellows

Although many patients with PTSD also have an eating disorder, they are not always properly assessed for eating pathology and related functional impairment.

Some therapists don’t feel adequately equipped to target eating-related concerns in these patients and so may refer them to other providers. This, said Mr. Powers, can prolong symptoms and further distress patients.

Mr. Powers noted childhood physical or sexual abuse may affect eating patterns in patients with PTSD. “The evidence suggests these types of trauma exposure can be risk factors for the development of an eating disorder.”

Undiagnosed eating pathology may exacerbate functional impairment from PTSD and weaken the impact of evidence-based treatment.

Such patients are challenging to treat as they may not have the requisite skills to fully engage in exposure therapy, an evidence-based approach to treat PTSD, said Mr. Powers.

To determine whether PTSD would be significantly linked to greater eating disorder impairment (EDI) compared with other anxiety-related diagnoses and whether this would impair treatment, investigators studied 748 patients with an anxiety disorder who were attending a cognitive behavioral therapy (CBT) clinic. Anxiety disorders included PTSD, obsessive-compulsive disorder (OCD), social anxiety, and panic disorder.

Participants completed the 16-item Clinical Impairment Assessment (CIA) questionnaire, which includes questions about eating habits and feelings about food, body shape, and weight over the previous 4 weeks. Participants also reported anxiety symptom severity at the beginning, during, and end of treatment.
 

Need for better screening

Results showed that compared with those who had other anxiety disorders, patients with PTSD were three times more likely to have disordered eating (odds ratio [OR], 3.06; 95% confidence interval [CI], 1.47-6.37; P = .003).

In addition, higher baseline CIA scores predicted poorer PTSD treatment outcome (beta = –1.4; 95% CI, –1.67 to –1.10; P < .01).

“Having higher baseline CIA scores meant that patients’ PTSD symptoms did not remit as strongly compared to those with lower scores,” said Mr. Powers.

Patients with both PTSD and an eating disorder may have difficulty with regulating emotions and tolerating distress, he said.

“They may use binge eating, purging, or food restriction as strategies to regulate emotions. These behaviors may allow patients to become numb to or avoid heightened emotions that come from having PTSD and an eating disorder.”

Prior research linked perfectionism tendencies to poorer response to PTSD treatment. Those with an eating disorder may share similar tendencies, said Mr. Powers.

“If someone is consistently thinking negatively about their eating or body to the point where it interrupts their functioning, they may not be as likely to fully engage with PTSD treatment,” he said.

Ideally, clinicians would screen all patients with PTSD for an eating disorder, said Mr. Powers. “If screening instruments aren’t feasible or available, even just inquiring about body image or history of maladaptive eating behaviors can be helpful.”

He added this could open up a conversation about a traumatic event in the patient’s past.
 

Confirmatory research

Commenting on the study, Karen S. Mitchell, PhD, clinical research psychologist, National Center for PTSD, VA Boston Healthcare System, and associate professor in psychiatry, Boston University, said she was “excited” to see this research.

Boston University

“Very few studies have examined the impact of baseline eating disorder symptoms on PTSD treatment outcomes or vice versa,” she said.

The study findings “add to the small but growing body of evidence suggesting that comorbid PTSD and eating disorder symptoms can impact recovery from each disorder,” she said.

She noted the importance of assessing comorbidity in patients presenting for treatment and of addressing comorbidity in both eating disorders and PTSD treatment. “But we need more research on how best to do this.”

Mr. Powers and Dr. Mitchell have reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

WASHINGTON –  Posttraumatic stress disorder (PTSD) is strongly linked to disordered eating, which in turn, impedes treatment for the anxiety disorder in new findings that underscore the need for better screening of eating disorder impairment (EDI).

“Eating-related and body-image concerns may be more prevalent than we think, and if not considered, these concerns can make psychotherapy treatment less effective,” study author Nick Powers, a doctoral student in clinical psychology, La Salle University, Philadelphia, told this news organization.

Nick Powers

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Common bedfellows

Although many patients with PTSD also have an eating disorder, they are not always properly assessed for eating pathology and related functional impairment.

Some therapists don’t feel adequately equipped to target eating-related concerns in these patients and so may refer them to other providers. This, said Mr. Powers, can prolong symptoms and further distress patients.

Mr. Powers noted childhood physical or sexual abuse may affect eating patterns in patients with PTSD. “The evidence suggests these types of trauma exposure can be risk factors for the development of an eating disorder.”

Undiagnosed eating pathology may exacerbate functional impairment from PTSD and weaken the impact of evidence-based treatment.

Such patients are challenging to treat as they may not have the requisite skills to fully engage in exposure therapy, an evidence-based approach to treat PTSD, said Mr. Powers.

To determine whether PTSD would be significantly linked to greater eating disorder impairment (EDI) compared with other anxiety-related diagnoses and whether this would impair treatment, investigators studied 748 patients with an anxiety disorder who were attending a cognitive behavioral therapy (CBT) clinic. Anxiety disorders included PTSD, obsessive-compulsive disorder (OCD), social anxiety, and panic disorder.

Participants completed the 16-item Clinical Impairment Assessment (CIA) questionnaire, which includes questions about eating habits and feelings about food, body shape, and weight over the previous 4 weeks. Participants also reported anxiety symptom severity at the beginning, during, and end of treatment.
 

Need for better screening

Results showed that compared with those who had other anxiety disorders, patients with PTSD were three times more likely to have disordered eating (odds ratio [OR], 3.06; 95% confidence interval [CI], 1.47-6.37; P = .003).

In addition, higher baseline CIA scores predicted poorer PTSD treatment outcome (beta = –1.4; 95% CI, –1.67 to –1.10; P < .01).

“Having higher baseline CIA scores meant that patients’ PTSD symptoms did not remit as strongly compared to those with lower scores,” said Mr. Powers.

Patients with both PTSD and an eating disorder may have difficulty with regulating emotions and tolerating distress, he said.

“They may use binge eating, purging, or food restriction as strategies to regulate emotions. These behaviors may allow patients to become numb to or avoid heightened emotions that come from having PTSD and an eating disorder.”

Prior research linked perfectionism tendencies to poorer response to PTSD treatment. Those with an eating disorder may share similar tendencies, said Mr. Powers.

“If someone is consistently thinking negatively about their eating or body to the point where it interrupts their functioning, they may not be as likely to fully engage with PTSD treatment,” he said.

Ideally, clinicians would screen all patients with PTSD for an eating disorder, said Mr. Powers. “If screening instruments aren’t feasible or available, even just inquiring about body image or history of maladaptive eating behaviors can be helpful.”

He added this could open up a conversation about a traumatic event in the patient’s past.
 

Confirmatory research

Commenting on the study, Karen S. Mitchell, PhD, clinical research psychologist, National Center for PTSD, VA Boston Healthcare System, and associate professor in psychiatry, Boston University, said she was “excited” to see this research.

Boston University

“Very few studies have examined the impact of baseline eating disorder symptoms on PTSD treatment outcomes or vice versa,” she said.

The study findings “add to the small but growing body of evidence suggesting that comorbid PTSD and eating disorder symptoms can impact recovery from each disorder,” she said.

She noted the importance of assessing comorbidity in patients presenting for treatment and of addressing comorbidity in both eating disorders and PTSD treatment. “But we need more research on how best to do this.”

Mr. Powers and Dr. Mitchell have reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Major depressive disorder (MDD) is linked to disruptions in energy and lipid metabolism, possibly caused by the interplay of the gut microbiome and blood metabolome, new research suggests.

Investigators found that MDD had specific metabolic “signatures” consisting of 124 metabolites that spanned energy and lipid pathways, with some involving the tricarboxylic acid cycle in particular. These changes in metabolites were consistent with differences in composition of several gut microbiota.

The researchers found that fatty acids and intermediate and very large lipoproteins changed in association with the depressive disease process. However, high-density lipoproteins and metabolites in the tricarboxylic acid cycle did not.

“As we wait to establish causal influences through clinical trials, clinicians should advise patients suffering from mood disorders to modify their diet by increasing the intake of fresh fruits, vegetables, and whole grains, as these provide the required fuel/fiber to the gut microbiota for their enrichment, and more short-chain fatty acids are produced for the optimal functioning of the body,” study investigator Najaf Amin, PhD, DSc, senior researcher, Nuffield Department of Population Health, Oxford University, England, told this news organization.

“At the same time, patients should be advised to minimize the intake of sugars and processed foods, which are known to have an inverse impact on the gut microbiome and are associated with higher inflammation,” she said.

The study was published online in JAMA Psychiatry.
 

MDD poorly understood

Although most antidepressants target the monoamine pathway, “evidence is increasing for a more complex interplay of multiple pathways involving a wide range of metabolic alterations spanning energy and lipid metabolism,” the authors wrote.

Previous research using the Nightingale proton nuclear magnetic resonance (NMR) metabolomics platform showed a “shift” toward decreased levels of high-density lipoproteins (HDLs) and increased levels of very low-density lipoproteins (VLDLs) and triglycerides among patients with depression.

The gut microbiome, which is primarily modulated by diet, “has been shown to be a major determinant of circulating lipids, specifically triglycerides and HDLs, and to regulate mitochondrial function,” the investigators noted. Patients with MDD are known to have disruptions in the gut microbiome.

The gut microbiome may “explain part of the shift in VLDL and HDL levels observed in patients with depression and if the metabolic signatures of the disease based on Nightingale metabolites can be used as a tool to infer the association between gut microbiome and depression.”

Dr. Amin called depression “one of the most poorly understood diseases, as underlying mechanisms remain elusive.”

Large-scale genetic studies “have shown that the contribution of genetics to depression is modest,” she continued. On the other hand, initial animal studies suggest the gut microbiome “may potentially have a causal influence on depression.”

Several studies have evaluated the influence of gut microbiome on depression, “but, due to small sample sizes and inadequate control for confounding factors, most of their findings were not reproducible.”

Harnessing the power of the UK Biobank, the investigators studied 58,257 individuals who were between the ages of 37 and 73 years at recruitment. They used data on NMR spectroscopy–based plasma metabolites in depression. Individuals who didn’t report depression at baseline served as controls.

Logistic regression analysis was used to test the association of metabolite levels with depression in four models, each with an increasing number of covariates.

To identify patterns of correlation in the “metabolic signatures of MDD and the human gut biome,” they regressed the metabolic signatures of MDD on the metabolic signatures of the gut microbiota and then regressed the metabolic signature of gut microbiota on the metabolic signatures of MDD.

Bidirectional 2-sample Mendelian randomization was used to ascertain the direction of the association observed between metabolites and MDD.

Individuals with lifetime and recurrent MDD were compared with controls (6,811 vs. 51,446 and 4,370 vs. 62,508, respectively).

Participants with lifetime MDD were significantly younger (median [IQR] age, 56 [49-62] years vs. 58 [51-64] years) and were more likely to be female in comparison with controls (54% vs. 35%).
 

‘Novel findings’

In the fully adjusted analysis, metabolic signatures of MDD were found to consist of 124 metabolites that spanned energy and lipid metabolism pathways.

The investigators noted that these “novel findings” included 49 metabolites encompassing those involved in the tricarboxylic acid cycle – citrate and pyruvate.

The findings revealed that fatty acids and intermediate and VLDL changed in association with the disease process. On the other hand, HDL and the metabolites in the tricarboxylic acid cycle did not.

“We observed that the genera Sellimonas, Eggerthella, Hungatella, and Lachnoclostridium were more abundant, while genera Ruminococcaceae ... Coprococcus, Lachnospiraceae ... Eubacterium ventriosum, Subdoligranulum, and family Ruminococcaceae were depleted in the guts of individuals with more symptoms of depression,” said Dr. Amin. “Of these, genus Eggerthella showed statistical evidence of being involved in the causal pathway.”

These microbes are involved in the synthesis of important neurotransmitters, such as gamma aminobutyric acid, butyrate, glutamate, and serotonin, she noted.

Butyrate produced by the gut can cross the blood-brain barrier, enter the brain, and affect transcriptional and translational activity or be used by the cells for generating energy, she added. “So basically, butyrate can influence depression through several routes – i.e., via immune regulation, genomic transcript/translation, and/or affecting energy metabolism.”
 

No causality

Commenting on the study, Emeran Mayer, MD, distinguished research professor of medicine, G. Oppenheimer Center for Neurobiology of Stress and Resilience and UCLA Brain Gut Microbiome Center, called it the “largest, most comprehensive and best validated association study to date providing further evidence for an association between gut microbial taxa, previously identified in patients with MDD, blood metabolites (generated by host and by microbes) and questionnaire data.”

However, “despite its strengths, the study does not allow [us] to identify a causal role of the microbiome alterations in the observed microbial and metabolic changes (fatty acids, Krebs cycle components),” cautioned Dr. Mayer, who was not involved with the study.

Moreover, “causality of gut microbial changes on the behavioral phenotype of depression cannot been inferred,” he concluded.

Metabolomics data were provided by the Alzheimer’s Disease Metabolomics Consortium. The study was funded wholly or in part by grants from the National Institute on Aging and Foundation for the National Institutes of Health. It was further supported by a grant from ZonMW Memorabel. Dr. Amin reports no relevant financial relationships. The other authors’ disclosures are listed oin the original article. Dr. Mayer is a scientific advisory board member of Danone, Axial Therapeutics, Viome, Amare, Mahana Therapeutics, Pendulum, Bloom Biosciences, and APC Microbiome Ireland.
 

A version of this article originally appeared on Medscape.com.

Major depressive disorder (MDD) is linked to disruptions in energy and lipid metabolism, possibly caused by the interplay of the gut microbiome and blood metabolome, new research suggests.

Investigators found that MDD had specific metabolic “signatures” consisting of 124 metabolites that spanned energy and lipid pathways, with some involving the tricarboxylic acid cycle in particular. These changes in metabolites were consistent with differences in composition of several gut microbiota.

The researchers found that fatty acids and intermediate and very large lipoproteins changed in association with the depressive disease process. However, high-density lipoproteins and metabolites in the tricarboxylic acid cycle did not.

“As we wait to establish causal influences through clinical trials, clinicians should advise patients suffering from mood disorders to modify their diet by increasing the intake of fresh fruits, vegetables, and whole grains, as these provide the required fuel/fiber to the gut microbiota for their enrichment, and more short-chain fatty acids are produced for the optimal functioning of the body,” study investigator Najaf Amin, PhD, DSc, senior researcher, Nuffield Department of Population Health, Oxford University, England, told this news organization.

“At the same time, patients should be advised to minimize the intake of sugars and processed foods, which are known to have an inverse impact on the gut microbiome and are associated with higher inflammation,” she said.

The study was published online in JAMA Psychiatry.
 

MDD poorly understood

Although most antidepressants target the monoamine pathway, “evidence is increasing for a more complex interplay of multiple pathways involving a wide range of metabolic alterations spanning energy and lipid metabolism,” the authors wrote.

Previous research using the Nightingale proton nuclear magnetic resonance (NMR) metabolomics platform showed a “shift” toward decreased levels of high-density lipoproteins (HDLs) and increased levels of very low-density lipoproteins (VLDLs) and triglycerides among patients with depression.

The gut microbiome, which is primarily modulated by diet, “has been shown to be a major determinant of circulating lipids, specifically triglycerides and HDLs, and to regulate mitochondrial function,” the investigators noted. Patients with MDD are known to have disruptions in the gut microbiome.

The gut microbiome may “explain part of the shift in VLDL and HDL levels observed in patients with depression and if the metabolic signatures of the disease based on Nightingale metabolites can be used as a tool to infer the association between gut microbiome and depression.”

Dr. Amin called depression “one of the most poorly understood diseases, as underlying mechanisms remain elusive.”

Large-scale genetic studies “have shown that the contribution of genetics to depression is modest,” she continued. On the other hand, initial animal studies suggest the gut microbiome “may potentially have a causal influence on depression.”

Several studies have evaluated the influence of gut microbiome on depression, “but, due to small sample sizes and inadequate control for confounding factors, most of their findings were not reproducible.”

Harnessing the power of the UK Biobank, the investigators studied 58,257 individuals who were between the ages of 37 and 73 years at recruitment. They used data on NMR spectroscopy–based plasma metabolites in depression. Individuals who didn’t report depression at baseline served as controls.

Logistic regression analysis was used to test the association of metabolite levels with depression in four models, each with an increasing number of covariates.

To identify patterns of correlation in the “metabolic signatures of MDD and the human gut biome,” they regressed the metabolic signatures of MDD on the metabolic signatures of the gut microbiota and then regressed the metabolic signature of gut microbiota on the metabolic signatures of MDD.

Bidirectional 2-sample Mendelian randomization was used to ascertain the direction of the association observed between metabolites and MDD.

Individuals with lifetime and recurrent MDD were compared with controls (6,811 vs. 51,446 and 4,370 vs. 62,508, respectively).

Participants with lifetime MDD were significantly younger (median [IQR] age, 56 [49-62] years vs. 58 [51-64] years) and were more likely to be female in comparison with controls (54% vs. 35%).
 

‘Novel findings’

In the fully adjusted analysis, metabolic signatures of MDD were found to consist of 124 metabolites that spanned energy and lipid metabolism pathways.

The investigators noted that these “novel findings” included 49 metabolites encompassing those involved in the tricarboxylic acid cycle – citrate and pyruvate.

The findings revealed that fatty acids and intermediate and VLDL changed in association with the disease process. On the other hand, HDL and the metabolites in the tricarboxylic acid cycle did not.

“We observed that the genera Sellimonas, Eggerthella, Hungatella, and Lachnoclostridium were more abundant, while genera Ruminococcaceae ... Coprococcus, Lachnospiraceae ... Eubacterium ventriosum, Subdoligranulum, and family Ruminococcaceae were depleted in the guts of individuals with more symptoms of depression,” said Dr. Amin. “Of these, genus Eggerthella showed statistical evidence of being involved in the causal pathway.”

These microbes are involved in the synthesis of important neurotransmitters, such as gamma aminobutyric acid, butyrate, glutamate, and serotonin, she noted.

Butyrate produced by the gut can cross the blood-brain barrier, enter the brain, and affect transcriptional and translational activity or be used by the cells for generating energy, she added. “So basically, butyrate can influence depression through several routes – i.e., via immune regulation, genomic transcript/translation, and/or affecting energy metabolism.”
 

No causality

Commenting on the study, Emeran Mayer, MD, distinguished research professor of medicine, G. Oppenheimer Center for Neurobiology of Stress and Resilience and UCLA Brain Gut Microbiome Center, called it the “largest, most comprehensive and best validated association study to date providing further evidence for an association between gut microbial taxa, previously identified in patients with MDD, blood metabolites (generated by host and by microbes) and questionnaire data.”

However, “despite its strengths, the study does not allow [us] to identify a causal role of the microbiome alterations in the observed microbial and metabolic changes (fatty acids, Krebs cycle components),” cautioned Dr. Mayer, who was not involved with the study.

Moreover, “causality of gut microbial changes on the behavioral phenotype of depression cannot been inferred,” he concluded.

Metabolomics data were provided by the Alzheimer’s Disease Metabolomics Consortium. The study was funded wholly or in part by grants from the National Institute on Aging and Foundation for the National Institutes of Health. It was further supported by a grant from ZonMW Memorabel. Dr. Amin reports no relevant financial relationships. The other authors’ disclosures are listed oin the original article. Dr. Mayer is a scientific advisory board member of Danone, Axial Therapeutics, Viome, Amare, Mahana Therapeutics, Pendulum, Bloom Biosciences, and APC Microbiome Ireland.
 

A version of this article originally appeared on Medscape.com.

Major depressive disorder (MDD) is linked to disruptions in energy and lipid metabolism, possibly caused by the interplay of the gut microbiome and blood metabolome, new research suggests.

Investigators found that MDD had specific metabolic “signatures” consisting of 124 metabolites that spanned energy and lipid pathways, with some involving the tricarboxylic acid cycle in particular. These changes in metabolites were consistent with differences in composition of several gut microbiota.

The researchers found that fatty acids and intermediate and very large lipoproteins changed in association with the depressive disease process. However, high-density lipoproteins and metabolites in the tricarboxylic acid cycle did not.

“As we wait to establish causal influences through clinical trials, clinicians should advise patients suffering from mood disorders to modify their diet by increasing the intake of fresh fruits, vegetables, and whole grains, as these provide the required fuel/fiber to the gut microbiota for their enrichment, and more short-chain fatty acids are produced for the optimal functioning of the body,” study investigator Najaf Amin, PhD, DSc, senior researcher, Nuffield Department of Population Health, Oxford University, England, told this news organization.

“At the same time, patients should be advised to minimize the intake of sugars and processed foods, which are known to have an inverse impact on the gut microbiome and are associated with higher inflammation,” she said.

The study was published online in JAMA Psychiatry.
 

MDD poorly understood

Although most antidepressants target the monoamine pathway, “evidence is increasing for a more complex interplay of multiple pathways involving a wide range of metabolic alterations spanning energy and lipid metabolism,” the authors wrote.

Previous research using the Nightingale proton nuclear magnetic resonance (NMR) metabolomics platform showed a “shift” toward decreased levels of high-density lipoproteins (HDLs) and increased levels of very low-density lipoproteins (VLDLs) and triglycerides among patients with depression.

The gut microbiome, which is primarily modulated by diet, “has been shown to be a major determinant of circulating lipids, specifically triglycerides and HDLs, and to regulate mitochondrial function,” the investigators noted. Patients with MDD are known to have disruptions in the gut microbiome.

The gut microbiome may “explain part of the shift in VLDL and HDL levels observed in patients with depression and if the metabolic signatures of the disease based on Nightingale metabolites can be used as a tool to infer the association between gut microbiome and depression.”

Dr. Amin called depression “one of the most poorly understood diseases, as underlying mechanisms remain elusive.”

Large-scale genetic studies “have shown that the contribution of genetics to depression is modest,” she continued. On the other hand, initial animal studies suggest the gut microbiome “may potentially have a causal influence on depression.”

Several studies have evaluated the influence of gut microbiome on depression, “but, due to small sample sizes and inadequate control for confounding factors, most of their findings were not reproducible.”

Harnessing the power of the UK Biobank, the investigators studied 58,257 individuals who were between the ages of 37 and 73 years at recruitment. They used data on NMR spectroscopy–based plasma metabolites in depression. Individuals who didn’t report depression at baseline served as controls.

Logistic regression analysis was used to test the association of metabolite levels with depression in four models, each with an increasing number of covariates.

To identify patterns of correlation in the “metabolic signatures of MDD and the human gut biome,” they regressed the metabolic signatures of MDD on the metabolic signatures of the gut microbiota and then regressed the metabolic signature of gut microbiota on the metabolic signatures of MDD.

Bidirectional 2-sample Mendelian randomization was used to ascertain the direction of the association observed between metabolites and MDD.

Individuals with lifetime and recurrent MDD were compared with controls (6,811 vs. 51,446 and 4,370 vs. 62,508, respectively).

Participants with lifetime MDD were significantly younger (median [IQR] age, 56 [49-62] years vs. 58 [51-64] years) and were more likely to be female in comparison with controls (54% vs. 35%).
 

‘Novel findings’

In the fully adjusted analysis, metabolic signatures of MDD were found to consist of 124 metabolites that spanned energy and lipid metabolism pathways.

The investigators noted that these “novel findings” included 49 metabolites encompassing those involved in the tricarboxylic acid cycle – citrate and pyruvate.

The findings revealed that fatty acids and intermediate and VLDL changed in association with the disease process. On the other hand, HDL and the metabolites in the tricarboxylic acid cycle did not.

“We observed that the genera Sellimonas, Eggerthella, Hungatella, and Lachnoclostridium were more abundant, while genera Ruminococcaceae ... Coprococcus, Lachnospiraceae ... Eubacterium ventriosum, Subdoligranulum, and family Ruminococcaceae were depleted in the guts of individuals with more symptoms of depression,” said Dr. Amin. “Of these, genus Eggerthella showed statistical evidence of being involved in the causal pathway.”

These microbes are involved in the synthesis of important neurotransmitters, such as gamma aminobutyric acid, butyrate, glutamate, and serotonin, she noted.

Butyrate produced by the gut can cross the blood-brain barrier, enter the brain, and affect transcriptional and translational activity or be used by the cells for generating energy, she added. “So basically, butyrate can influence depression through several routes – i.e., via immune regulation, genomic transcript/translation, and/or affecting energy metabolism.”
 

No causality

Commenting on the study, Emeran Mayer, MD, distinguished research professor of medicine, G. Oppenheimer Center for Neurobiology of Stress and Resilience and UCLA Brain Gut Microbiome Center, called it the “largest, most comprehensive and best validated association study to date providing further evidence for an association between gut microbial taxa, previously identified in patients with MDD, blood metabolites (generated by host and by microbes) and questionnaire data.”

However, “despite its strengths, the study does not allow [us] to identify a causal role of the microbiome alterations in the observed microbial and metabolic changes (fatty acids, Krebs cycle components),” cautioned Dr. Mayer, who was not involved with the study.

Moreover, “causality of gut microbial changes on the behavioral phenotype of depression cannot been inferred,” he concluded.

Metabolomics data were provided by the Alzheimer’s Disease Metabolomics Consortium. The study was funded wholly or in part by grants from the National Institute on Aging and Foundation for the National Institutes of Health. It was further supported by a grant from ZonMW Memorabel. Dr. Amin reports no relevant financial relationships. The other authors’ disclosures are listed oin the original article. Dr. Mayer is a scientific advisory board member of Danone, Axial Therapeutics, Viome, Amare, Mahana Therapeutics, Pendulum, Bloom Biosciences, and APC Microbiome Ireland.
 

A version of this article originally appeared on Medscape.com.

Walnuts have been associated with better cognitive development and psychological maturation in teens, new research shows. Adolescents who consumed walnuts for at least 100 days showed improved sustained attention and fluid intelligence as well as a reduction in symptoms of attension deficit hyperactivity disorder, compared with matched controls who did not consume the nuts. However, there were no statistically significant changes between the groups in other parameters, such as working memory and executive function.

Clinicians should advise adolescents “to eat a handful of walnuts three times a week for the rest of their lives. They may have a healthier brain with better cognitive function,” said senior investigator Jordi Julvez, PhD, group leader at the Institute of Health Research Pere Virgili, Barcelona, and associated researcher at the Barcelona Institute for Global Health.

The study was published online in eClinicalMedicine.
 

Rich source of omega-3s

Adolescence is “a period of refinement of brain connectivity and complex behaviors,” the investigators noted.  

Previous research suggests polyunsaturated fatty acids are key in central nervous system architecture and function during times of neural development, with three specific PUFAs playing an “essential developmental role.”

Two omega-3 fatty acids – docosahexaenoic acid and eicosapentaenoic acid – are PUFAs that must be obtained through diet, mainly from seafood. Walnuts are “among the richest sources” of plant-derived omega-3 fatty acids, particularly alpha-linolenic acid (ALA), a precursor for longer-chain EPA and DHA.

ALA independently “has positive effects on brain function and plasticity,” the authors wrote. In addition, walnut constituents – particularly polyphenols and other bioactive compounds – “may act synergistically with ALA to foster brain health.”

Earlier small studies have found positive associations between walnut consumption and cognitive function in children, adolescents, and young adults, but to date, no randomized controlled trial has focused on the effect of walnut consumption on adolescent neuropsychological function.

The researchers studied 771 healthy adolescents (aged 11-16 years, mean age 14) drawn from 12 Spanish high schools. Participants were instructed to follow healthy eating recommendations and were randomly assigned 1:1 to the intervention (n = 386) or the control group (n = 385).

At baseline and after 6 months, they completed neuropsychological tests and behavioral rating scales. The Attention Network Test assessed attention, and the N-back test was used to assess working memory. The Tests of Primary Mental Abilities assessed fluid intelligence. Risky decision-making was tested using the Roulettes Task.
 

Fruit and nuts

Participants also completed the Strengths and Difficulties Questionnaire, which provided a total score of problem behavior. Teachers filled out the ADHD DSM-IV form list to provide additional information about ADHD behaviors.

The intervention group received 30 grams/day of raw California walnut kernels to incorporate into their daily diet. It is estimated that this walnut contains about 9 g of ALA per 100 g.

All participants received a seasonal fruit calendar and were asked to eat at least one piece of seasonal fruit daily.

Parents reported their child’s daily walnut consumption, with adherence defined as 100 or more days of eating walnuts during the 6-month period.

All main analyses were based on an intention-to-treat method (participants were analyzed according to their original group assignment, regardless of their adherence to the intervention).

The researchers also conducted a secondary per-protocol analysis, comparing the intervention and control groups to estimate the effect if all participants had adhered to their assigned intervention. They censored data for participants who reported eating walnuts for less than 100 days during the 6-month trial period.

Secondary outcomes included changes in height, weight, waist circumference, and BMI, as well as red blood cell proportions of omega-3 fatty acids (DHA, EPA, and ALA) at baseline and after 6 months.
 

Adherence counts

Most participants had “medium” or “high” levels of adherence to the Mediterranean diet, with “no meaningful differences” at baseline between the intervention and control groups in lifestyle characteristics or mean scores in all primary endpoints.

In the ITT analysis, there were no statistically significant differences in primary outcomes between the groups following the intervention. As for secondary outcomes, the RBC ALA significantly increased in the walnuts group but not the control group (coefficient, 0.04%; 95% confidence interval, 0.03%-0.06%; P < .0001).

However, there were differences in primary outcomes between the groups in the per-protocol analysis: The adherence-adjusted effect on improvement in attention score was −11.26 ms; 95% CI, −19.92 to −2.60; P = .011) for the intervention versus the control group.

The per-protocol analysis showed other differences: an improvement in fluid intelligence score (1.78; 95% CI, 0.90 - 2.67; P < .0001) and a reduction in ADHD symptom score (−2.18; 95% CI, −3.70 to −0.67; P = .0050).

“Overall, no significant differences were found in the intervention group in relation to the control group,” Dr. Julvez said in a news release. “But if the adherence factor is considered, then positive results are observed, since participants who most closely followed the guidelines – in terms of the recommended dose of walnuts and the number of days of consumption – did show improvements in the neuropsychological functions evaluated.”

Adolescence “is a time of great biological changes. Hormonal transformation occurs, which in turn is responsible for stimulating the synaptic growth of the frontal lobe,” he continued, adding that this brain region “enables neuropsychological maturation of more complex emotional and cognitive functions.”

“Neurons that are well nourished with these types of fatty acids will be able to grow and form new, stronger synapses,” he said.
 

Food as medicine

Uma Naidoo, MD, director of nutritional and lifestyle psychiatry at Massachusetts General Hospital, Boston, “commends” the researchers for conducting an RCT with a “robust” sample size and said she is “excited to see research like this furthering functional nutrition for mental health,” as she believes that “food is medicine.”

Dr. Naidoo, a professional chef, nutritional biologist, and author of the book “This Is Your Brain on Food,” said the findings “align” with her own approach to nutritional psychiatry and are also “in line” with her clinical practice.

However, although these results are “promising,” more research is needed across more diverse populations to “make sure these results are truly generalizable,” said Dr. Naidoo, a faculty member at Harvard Medical School, Boston, who was not involved with the study.

She “envisions a future where the research is so advanced that we can ‘dose’ these healthy whole foods for specific psychiatric symptoms and conditions.”

This study was supported by Instituto de Salud Carlos III (co-funded by European Union Regional Development Fund “A way to make Europe”). The California Walnut Commission has given support by supplying the walnuts for free for the Walnuts Smart Snack Dietary Intervention Trial. Dr. Julvez holds a Miguel Servet-II contract awarded by the Instituto de Salud Carlos III (co-funded by European Union Social Fund). The other authors’ disclosures are listed in the original article. Dr. Naidoo reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Walnuts have been associated with better cognitive development and psychological maturation in teens, new research shows. Adolescents who consumed walnuts for at least 100 days showed improved sustained attention and fluid intelligence as well as a reduction in symptoms of attension deficit hyperactivity disorder, compared with matched controls who did not consume the nuts. However, there were no statistically significant changes between the groups in other parameters, such as working memory and executive function.

Clinicians should advise adolescents “to eat a handful of walnuts three times a week for the rest of their lives. They may have a healthier brain with better cognitive function,” said senior investigator Jordi Julvez, PhD, group leader at the Institute of Health Research Pere Virgili, Barcelona, and associated researcher at the Barcelona Institute for Global Health.

The study was published online in eClinicalMedicine.
 

Rich source of omega-3s

Adolescence is “a period of refinement of brain connectivity and complex behaviors,” the investigators noted.  

Previous research suggests polyunsaturated fatty acids are key in central nervous system architecture and function during times of neural development, with three specific PUFAs playing an “essential developmental role.”

Two omega-3 fatty acids – docosahexaenoic acid and eicosapentaenoic acid – are PUFAs that must be obtained through diet, mainly from seafood. Walnuts are “among the richest sources” of plant-derived omega-3 fatty acids, particularly alpha-linolenic acid (ALA), a precursor for longer-chain EPA and DHA.

ALA independently “has positive effects on brain function and plasticity,” the authors wrote. In addition, walnut constituents – particularly polyphenols and other bioactive compounds – “may act synergistically with ALA to foster brain health.”

Earlier small studies have found positive associations between walnut consumption and cognitive function in children, adolescents, and young adults, but to date, no randomized controlled trial has focused on the effect of walnut consumption on adolescent neuropsychological function.

The researchers studied 771 healthy adolescents (aged 11-16 years, mean age 14) drawn from 12 Spanish high schools. Participants were instructed to follow healthy eating recommendations and were randomly assigned 1:1 to the intervention (n = 386) or the control group (n = 385).

At baseline and after 6 months, they completed neuropsychological tests and behavioral rating scales. The Attention Network Test assessed attention, and the N-back test was used to assess working memory. The Tests of Primary Mental Abilities assessed fluid intelligence. Risky decision-making was tested using the Roulettes Task.
 

Fruit and nuts

Participants also completed the Strengths and Difficulties Questionnaire, which provided a total score of problem behavior. Teachers filled out the ADHD DSM-IV form list to provide additional information about ADHD behaviors.

The intervention group received 30 grams/day of raw California walnut kernels to incorporate into their daily diet. It is estimated that this walnut contains about 9 g of ALA per 100 g.

All participants received a seasonal fruit calendar and were asked to eat at least one piece of seasonal fruit daily.

Parents reported their child’s daily walnut consumption, with adherence defined as 100 or more days of eating walnuts during the 6-month period.

All main analyses were based on an intention-to-treat method (participants were analyzed according to their original group assignment, regardless of their adherence to the intervention).

The researchers also conducted a secondary per-protocol analysis, comparing the intervention and control groups to estimate the effect if all participants had adhered to their assigned intervention. They censored data for participants who reported eating walnuts for less than 100 days during the 6-month trial period.

Secondary outcomes included changes in height, weight, waist circumference, and BMI, as well as red blood cell proportions of omega-3 fatty acids (DHA, EPA, and ALA) at baseline and after 6 months.
 

Adherence counts

Most participants had “medium” or “high” levels of adherence to the Mediterranean diet, with “no meaningful differences” at baseline between the intervention and control groups in lifestyle characteristics or mean scores in all primary endpoints.

In the ITT analysis, there were no statistically significant differences in primary outcomes between the groups following the intervention. As for secondary outcomes, the RBC ALA significantly increased in the walnuts group but not the control group (coefficient, 0.04%; 95% confidence interval, 0.03%-0.06%; P < .0001).

However, there were differences in primary outcomes between the groups in the per-protocol analysis: The adherence-adjusted effect on improvement in attention score was −11.26 ms; 95% CI, −19.92 to −2.60; P = .011) for the intervention versus the control group.

The per-protocol analysis showed other differences: an improvement in fluid intelligence score (1.78; 95% CI, 0.90 - 2.67; P < .0001) and a reduction in ADHD symptom score (−2.18; 95% CI, −3.70 to −0.67; P = .0050).

“Overall, no significant differences were found in the intervention group in relation to the control group,” Dr. Julvez said in a news release. “But if the adherence factor is considered, then positive results are observed, since participants who most closely followed the guidelines – in terms of the recommended dose of walnuts and the number of days of consumption – did show improvements in the neuropsychological functions evaluated.”

Adolescence “is a time of great biological changes. Hormonal transformation occurs, which in turn is responsible for stimulating the synaptic growth of the frontal lobe,” he continued, adding that this brain region “enables neuropsychological maturation of more complex emotional and cognitive functions.”

“Neurons that are well nourished with these types of fatty acids will be able to grow and form new, stronger synapses,” he said.
 

Food as medicine

Uma Naidoo, MD, director of nutritional and lifestyle psychiatry at Massachusetts General Hospital, Boston, “commends” the researchers for conducting an RCT with a “robust” sample size and said she is “excited to see research like this furthering functional nutrition for mental health,” as she believes that “food is medicine.”

Dr. Naidoo, a professional chef, nutritional biologist, and author of the book “This Is Your Brain on Food,” said the findings “align” with her own approach to nutritional psychiatry and are also “in line” with her clinical practice.

However, although these results are “promising,” more research is needed across more diverse populations to “make sure these results are truly generalizable,” said Dr. Naidoo, a faculty member at Harvard Medical School, Boston, who was not involved with the study.

She “envisions a future where the research is so advanced that we can ‘dose’ these healthy whole foods for specific psychiatric symptoms and conditions.”

This study was supported by Instituto de Salud Carlos III (co-funded by European Union Regional Development Fund “A way to make Europe”). The California Walnut Commission has given support by supplying the walnuts for free for the Walnuts Smart Snack Dietary Intervention Trial. Dr. Julvez holds a Miguel Servet-II contract awarded by the Instituto de Salud Carlos III (co-funded by European Union Social Fund). The other authors’ disclosures are listed in the original article. Dr. Naidoo reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Walnuts have been associated with better cognitive development and psychological maturation in teens, new research shows. Adolescents who consumed walnuts for at least 100 days showed improved sustained attention and fluid intelligence as well as a reduction in symptoms of attension deficit hyperactivity disorder, compared with matched controls who did not consume the nuts. However, there were no statistically significant changes between the groups in other parameters, such as working memory and executive function.

Clinicians should advise adolescents “to eat a handful of walnuts three times a week for the rest of their lives. They may have a healthier brain with better cognitive function,” said senior investigator Jordi Julvez, PhD, group leader at the Institute of Health Research Pere Virgili, Barcelona, and associated researcher at the Barcelona Institute for Global Health.

The study was published online in eClinicalMedicine.
 

Rich source of omega-3s

Adolescence is “a period of refinement of brain connectivity and complex behaviors,” the investigators noted.  

Previous research suggests polyunsaturated fatty acids are key in central nervous system architecture and function during times of neural development, with three specific PUFAs playing an “essential developmental role.”

Two omega-3 fatty acids – docosahexaenoic acid and eicosapentaenoic acid – are PUFAs that must be obtained through diet, mainly from seafood. Walnuts are “among the richest sources” of plant-derived omega-3 fatty acids, particularly alpha-linolenic acid (ALA), a precursor for longer-chain EPA and DHA.

ALA independently “has positive effects on brain function and plasticity,” the authors wrote. In addition, walnut constituents – particularly polyphenols and other bioactive compounds – “may act synergistically with ALA to foster brain health.”

Earlier small studies have found positive associations between walnut consumption and cognitive function in children, adolescents, and young adults, but to date, no randomized controlled trial has focused on the effect of walnut consumption on adolescent neuropsychological function.

The researchers studied 771 healthy adolescents (aged 11-16 years, mean age 14) drawn from 12 Spanish high schools. Participants were instructed to follow healthy eating recommendations and were randomly assigned 1:1 to the intervention (n = 386) or the control group (n = 385).

At baseline and after 6 months, they completed neuropsychological tests and behavioral rating scales. The Attention Network Test assessed attention, and the N-back test was used to assess working memory. The Tests of Primary Mental Abilities assessed fluid intelligence. Risky decision-making was tested using the Roulettes Task.
 

Fruit and nuts

Participants also completed the Strengths and Difficulties Questionnaire, which provided a total score of problem behavior. Teachers filled out the ADHD DSM-IV form list to provide additional information about ADHD behaviors.

The intervention group received 30 grams/day of raw California walnut kernels to incorporate into their daily diet. It is estimated that this walnut contains about 9 g of ALA per 100 g.

All participants received a seasonal fruit calendar and were asked to eat at least one piece of seasonal fruit daily.

Parents reported their child’s daily walnut consumption, with adherence defined as 100 or more days of eating walnuts during the 6-month period.

All main analyses were based on an intention-to-treat method (participants were analyzed according to their original group assignment, regardless of their adherence to the intervention).

The researchers also conducted a secondary per-protocol analysis, comparing the intervention and control groups to estimate the effect if all participants had adhered to their assigned intervention. They censored data for participants who reported eating walnuts for less than 100 days during the 6-month trial period.

Secondary outcomes included changes in height, weight, waist circumference, and BMI, as well as red blood cell proportions of omega-3 fatty acids (DHA, EPA, and ALA) at baseline and after 6 months.
 

Adherence counts

Most participants had “medium” or “high” levels of adherence to the Mediterranean diet, with “no meaningful differences” at baseline between the intervention and control groups in lifestyle characteristics or mean scores in all primary endpoints.

In the ITT analysis, there were no statistically significant differences in primary outcomes between the groups following the intervention. As for secondary outcomes, the RBC ALA significantly increased in the walnuts group but not the control group (coefficient, 0.04%; 95% confidence interval, 0.03%-0.06%; P < .0001).

However, there were differences in primary outcomes between the groups in the per-protocol analysis: The adherence-adjusted effect on improvement in attention score was −11.26 ms; 95% CI, −19.92 to −2.60; P = .011) for the intervention versus the control group.

The per-protocol analysis showed other differences: an improvement in fluid intelligence score (1.78; 95% CI, 0.90 - 2.67; P < .0001) and a reduction in ADHD symptom score (−2.18; 95% CI, −3.70 to −0.67; P = .0050).

“Overall, no significant differences were found in the intervention group in relation to the control group,” Dr. Julvez said in a news release. “But if the adherence factor is considered, then positive results are observed, since participants who most closely followed the guidelines – in terms of the recommended dose of walnuts and the number of days of consumption – did show improvements in the neuropsychological functions evaluated.”

Adolescence “is a time of great biological changes. Hormonal transformation occurs, which in turn is responsible for stimulating the synaptic growth of the frontal lobe,” he continued, adding that this brain region “enables neuropsychological maturation of more complex emotional and cognitive functions.”

“Neurons that are well nourished with these types of fatty acids will be able to grow and form new, stronger synapses,” he said.
 

Food as medicine

Uma Naidoo, MD, director of nutritional and lifestyle psychiatry at Massachusetts General Hospital, Boston, “commends” the researchers for conducting an RCT with a “robust” sample size and said she is “excited to see research like this furthering functional nutrition for mental health,” as she believes that “food is medicine.”

Dr. Naidoo, a professional chef, nutritional biologist, and author of the book “This Is Your Brain on Food,” said the findings “align” with her own approach to nutritional psychiatry and are also “in line” with her clinical practice.

However, although these results are “promising,” more research is needed across more diverse populations to “make sure these results are truly generalizable,” said Dr. Naidoo, a faculty member at Harvard Medical School, Boston, who was not involved with the study.

She “envisions a future where the research is so advanced that we can ‘dose’ these healthy whole foods for specific psychiatric symptoms and conditions.”

This study was supported by Instituto de Salud Carlos III (co-funded by European Union Regional Development Fund “A way to make Europe”). The California Walnut Commission has given support by supplying the walnuts for free for the Walnuts Smart Snack Dietary Intervention Trial. Dr. Julvez holds a Miguel Servet-II contract awarded by the Instituto de Salud Carlos III (co-funded by European Union Social Fund). The other authors’ disclosures are listed in the original article. Dr. Naidoo reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

WASHINGTON – Psilocybin is safe and effective in patients with body dysmorphic disorder (BDD), preliminary findings of a small pilot study show.

“The results suggest that psilocybin appears to be relatively safe and potentially helpful for people with BDD, and that it has a broader scope than just depression,” study investigator Franklin Schneier, MD, codirector of the Anxiety Disorders Clinic, New York State Psychiatric Institute, and special lecturer in psychiatry at Columbia University Medical Center in New York City, told this news organization.

So far, psilocybin has mostly been examined in clinical trials among patients with major depression. Dr. Schneier said he is aware of only a single case in the literature of its use in BDD: a patient who self-treated with psilocybin and reported symptom improvement.

The current study was presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Few treatment options

Patients with BDD are preoccupied with a body part they perceive as ugly or defective, “and not just mildly so,” said Dr. Schneier. “It bothers them to the extreme such that they may obsess about it on and off all day long.”

Such patients may engage in compulsive behaviors like constantly checking themselves in the mirror, and going to great lengths to conceal the body part they feel is defective. “They often seek out cosmetic procedures that objectively aren’t warranted,” said Dr. Schneier.

BDD patients often have comorbid depression, and many attempt suicide. As with other anxiety and depressive disorders, BDD is twice as prevalent in women vs. men, said Dr. Schneier.

Selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT) are the only approved therapies for BDD.

The investigators thought there may be a good chance BDD patients could benefit from psilocybin. Psilocybin alters bodily self-awareness, which “might shake up people’s beliefs about their abnormal body perceptions,” said Dr. Schneier.

There’s also some suggestion that psilocybin relaxes inflexible thinking, he added. “People with BDD have very rigid beliefs about their body distortions that aren’t easily swayed by logic.”

The study included 12 adults (8 women, 4 men) with a mean age of 34 years and moderate to severe BDD who failed at least one SSRI course and had had BDD for an average of 21 years.

Participants had preliminary sessions with a therapist familiar with psilocybin who prepared them psychologically and discussed what to expect from the experience. On the day of the intervention, subjects took a single 25 mg oral dose of synthetic psilocybin in a comfortable setting.

Therapists were present for the next 8 hours to answer questions and support subjects through the experience.
 

High response rate

The primary efficacy outcome was change in the BDD Yale-Brown Obsessive Compulsive Disorder Scale Modified (BDD-YBOCS) total score.

The mean baseline BDD-YBOCS score was 29.17. Researchers regularly assessed this score in the following weeks.

At 12 weeks, BDD-YBOCS scores decreased significantly from baseline (P < .001) with a large effect size (partial eta squared = .54).

However, said Dr. Schneier, what really stood out was the proportion of responders. At week 12, seven (58%) of the 12 participants were responders, as defined by a 30% or greater decrease in the BDD-YBOCS score. Of these, three were “almost symptom-free,” he added.

A number of secondary outcomes, including conviction of belief, disability, and negative affect, also significantly improved.

It’s too early to determine if additional treatment is required. The investigators plan to follow-up with the cohort at 1 year.

Although exciting, these early results warrant caution, said Dr. Schneier. “On the one hand, this is a sample of people who have struggled for a long time and have failed previous therapies, so that’s good. But on the other hand, it’s an open trial with no placebo group, and everyone has high expectations, so we don’t know how much of a placebo effect there was.”

Most adverse events, including headaches and fatigue, were mild and resolved within the first week after dosing, and there were no serious adverse events.

Based on these findings, Dr. Schneier said controlled trials of psilocybin in BDD are warranted.
 

Need for scientific rigor

Commenting on the research, Charles B. Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, University of Texas at Austin, said while promising, psilocybin is “not for everyone” and patients need to be closely screened.

University of Texas at Austin

“We want to know their medical history and if they have a family history of schizophrenia or bipolar disorder. We don’t know whether these [psychedelic] medicines might trigger an episode.”

Dr. Nemeroff also noted there’s a risk of “troubling” side effects from the drug.

“My view is psilocybin clearly has therapeutic effects and we need to apply scientific rigor as we would any medicine in order to determine the risk/benefit ratio,” said Dr. Nemeroff, who was not associated with this psilocybin trial.

In addition, psilocybin is being tested in conditions other than BDD and major depression, including anorexia nervosa, postpartum depression, and alcohol use disorder, he added.

The study received funding from COMPASS Pathways PLC.

Dr. Nemeroff reports he has received research support from the NIH and Stanley Medical Research Institute; served as a consultant for Bracket (Clintara), Fortress Biotech, Intra-Cellular Therapies, Janssen Research and Development, Magstim, Navitor Pharmaceuticals, Sunovion Pharmaceuticals, Taisho Pharmaceuticals, Takeda, TC MSO, and Xhale; served on scientific advisory boards for the American Foundation for Suicide Prevention, the Anxiety and Depression Association of America, Bracket (Clintara), Brain and Behavior Research Foundation, Laureate Institute for Brain Research, Skyland Trail, and Xhale; is a stockholder in AbbVie, Antares, BI Gen Holdings, Celgene, OPKO Health, Seattle Genetics, and Xhale; serves on the board of directors for the American Foundation for Suicide Prevention, Anxiety and Depression Association of America, and Gratitude America; has received income or equity of $10,000 or more from American Psychiatric Publishing, Bracket (Clintara), Magstim, CME Outfitters, and Intra-Cellular Therapies; and holds patents on a method and devices for transdermal delivery of lithium and a method of assessing antidepressant drug therapy via transport inhibition of monoamine neurotransmitters by ex vivo assay.

A version of this article first appeared on Medscape.com.

WASHINGTON – Psilocybin is safe and effective in patients with body dysmorphic disorder (BDD), preliminary findings of a small pilot study show.

“The results suggest that psilocybin appears to be relatively safe and potentially helpful for people with BDD, and that it has a broader scope than just depression,” study investigator Franklin Schneier, MD, codirector of the Anxiety Disorders Clinic, New York State Psychiatric Institute, and special lecturer in psychiatry at Columbia University Medical Center in New York City, told this news organization.

So far, psilocybin has mostly been examined in clinical trials among patients with major depression. Dr. Schneier said he is aware of only a single case in the literature of its use in BDD: a patient who self-treated with psilocybin and reported symptom improvement.

The current study was presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Few treatment options

Patients with BDD are preoccupied with a body part they perceive as ugly or defective, “and not just mildly so,” said Dr. Schneier. “It bothers them to the extreme such that they may obsess about it on and off all day long.”

Such patients may engage in compulsive behaviors like constantly checking themselves in the mirror, and going to great lengths to conceal the body part they feel is defective. “They often seek out cosmetic procedures that objectively aren’t warranted,” said Dr. Schneier.

BDD patients often have comorbid depression, and many attempt suicide. As with other anxiety and depressive disorders, BDD is twice as prevalent in women vs. men, said Dr. Schneier.

Selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT) are the only approved therapies for BDD.

The investigators thought there may be a good chance BDD patients could benefit from psilocybin. Psilocybin alters bodily self-awareness, which “might shake up people’s beliefs about their abnormal body perceptions,” said Dr. Schneier.

There’s also some suggestion that psilocybin relaxes inflexible thinking, he added. “People with BDD have very rigid beliefs about their body distortions that aren’t easily swayed by logic.”

The study included 12 adults (8 women, 4 men) with a mean age of 34 years and moderate to severe BDD who failed at least one SSRI course and had had BDD for an average of 21 years.

Participants had preliminary sessions with a therapist familiar with psilocybin who prepared them psychologically and discussed what to expect from the experience. On the day of the intervention, subjects took a single 25 mg oral dose of synthetic psilocybin in a comfortable setting.

Therapists were present for the next 8 hours to answer questions and support subjects through the experience.
 

High response rate

The primary efficacy outcome was change in the BDD Yale-Brown Obsessive Compulsive Disorder Scale Modified (BDD-YBOCS) total score.

The mean baseline BDD-YBOCS score was 29.17. Researchers regularly assessed this score in the following weeks.

At 12 weeks, BDD-YBOCS scores decreased significantly from baseline (P < .001) with a large effect size (partial eta squared = .54).

However, said Dr. Schneier, what really stood out was the proportion of responders. At week 12, seven (58%) of the 12 participants were responders, as defined by a 30% or greater decrease in the BDD-YBOCS score. Of these, three were “almost symptom-free,” he added.

A number of secondary outcomes, including conviction of belief, disability, and negative affect, also significantly improved.

It’s too early to determine if additional treatment is required. The investigators plan to follow-up with the cohort at 1 year.

Although exciting, these early results warrant caution, said Dr. Schneier. “On the one hand, this is a sample of people who have struggled for a long time and have failed previous therapies, so that’s good. But on the other hand, it’s an open trial with no placebo group, and everyone has high expectations, so we don’t know how much of a placebo effect there was.”

Most adverse events, including headaches and fatigue, were mild and resolved within the first week after dosing, and there were no serious adverse events.

Based on these findings, Dr. Schneier said controlled trials of psilocybin in BDD are warranted.
 

Need for scientific rigor

Commenting on the research, Charles B. Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, University of Texas at Austin, said while promising, psilocybin is “not for everyone” and patients need to be closely screened.

University of Texas at Austin

“We want to know their medical history and if they have a family history of schizophrenia or bipolar disorder. We don’t know whether these [psychedelic] medicines might trigger an episode.”

Dr. Nemeroff also noted there’s a risk of “troubling” side effects from the drug.

“My view is psilocybin clearly has therapeutic effects and we need to apply scientific rigor as we would any medicine in order to determine the risk/benefit ratio,” said Dr. Nemeroff, who was not associated with this psilocybin trial.

In addition, psilocybin is being tested in conditions other than BDD and major depression, including anorexia nervosa, postpartum depression, and alcohol use disorder, he added.

The study received funding from COMPASS Pathways PLC.

Dr. Nemeroff reports he has received research support from the NIH and Stanley Medical Research Institute; served as a consultant for Bracket (Clintara), Fortress Biotech, Intra-Cellular Therapies, Janssen Research and Development, Magstim, Navitor Pharmaceuticals, Sunovion Pharmaceuticals, Taisho Pharmaceuticals, Takeda, TC MSO, and Xhale; served on scientific advisory boards for the American Foundation for Suicide Prevention, the Anxiety and Depression Association of America, Bracket (Clintara), Brain and Behavior Research Foundation, Laureate Institute for Brain Research, Skyland Trail, and Xhale; is a stockholder in AbbVie, Antares, BI Gen Holdings, Celgene, OPKO Health, Seattle Genetics, and Xhale; serves on the board of directors for the American Foundation for Suicide Prevention, Anxiety and Depression Association of America, and Gratitude America; has received income or equity of $10,000 or more from American Psychiatric Publishing, Bracket (Clintara), Magstim, CME Outfitters, and Intra-Cellular Therapies; and holds patents on a method and devices for transdermal delivery of lithium and a method of assessing antidepressant drug therapy via transport inhibition of monoamine neurotransmitters by ex vivo assay.

A version of this article first appeared on Medscape.com.

WASHINGTON – Psilocybin is safe and effective in patients with body dysmorphic disorder (BDD), preliminary findings of a small pilot study show.

“The results suggest that psilocybin appears to be relatively safe and potentially helpful for people with BDD, and that it has a broader scope than just depression,” study investigator Franklin Schneier, MD, codirector of the Anxiety Disorders Clinic, New York State Psychiatric Institute, and special lecturer in psychiatry at Columbia University Medical Center in New York City, told this news organization.

So far, psilocybin has mostly been examined in clinical trials among patients with major depression. Dr. Schneier said he is aware of only a single case in the literature of its use in BDD: a patient who self-treated with psilocybin and reported symptom improvement.

The current study was presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Few treatment options

Patients with BDD are preoccupied with a body part they perceive as ugly or defective, “and not just mildly so,” said Dr. Schneier. “It bothers them to the extreme such that they may obsess about it on and off all day long.”

Such patients may engage in compulsive behaviors like constantly checking themselves in the mirror, and going to great lengths to conceal the body part they feel is defective. “They often seek out cosmetic procedures that objectively aren’t warranted,” said Dr. Schneier.

BDD patients often have comorbid depression, and many attempt suicide. As with other anxiety and depressive disorders, BDD is twice as prevalent in women vs. men, said Dr. Schneier.

Selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT) are the only approved therapies for BDD.

The investigators thought there may be a good chance BDD patients could benefit from psilocybin. Psilocybin alters bodily self-awareness, which “might shake up people’s beliefs about their abnormal body perceptions,” said Dr. Schneier.

There’s also some suggestion that psilocybin relaxes inflexible thinking, he added. “People with BDD have very rigid beliefs about their body distortions that aren’t easily swayed by logic.”

The study included 12 adults (8 women, 4 men) with a mean age of 34 years and moderate to severe BDD who failed at least one SSRI course and had had BDD for an average of 21 years.

Participants had preliminary sessions with a therapist familiar with psilocybin who prepared them psychologically and discussed what to expect from the experience. On the day of the intervention, subjects took a single 25 mg oral dose of synthetic psilocybin in a comfortable setting.

Therapists were present for the next 8 hours to answer questions and support subjects through the experience.
 

High response rate

The primary efficacy outcome was change in the BDD Yale-Brown Obsessive Compulsive Disorder Scale Modified (BDD-YBOCS) total score.

The mean baseline BDD-YBOCS score was 29.17. Researchers regularly assessed this score in the following weeks.

At 12 weeks, BDD-YBOCS scores decreased significantly from baseline (P < .001) with a large effect size (partial eta squared = .54).

However, said Dr. Schneier, what really stood out was the proportion of responders. At week 12, seven (58%) of the 12 participants were responders, as defined by a 30% or greater decrease in the BDD-YBOCS score. Of these, three were “almost symptom-free,” he added.

A number of secondary outcomes, including conviction of belief, disability, and negative affect, also significantly improved.

It’s too early to determine if additional treatment is required. The investigators plan to follow-up with the cohort at 1 year.

Although exciting, these early results warrant caution, said Dr. Schneier. “On the one hand, this is a sample of people who have struggled for a long time and have failed previous therapies, so that’s good. But on the other hand, it’s an open trial with no placebo group, and everyone has high expectations, so we don’t know how much of a placebo effect there was.”

Most adverse events, including headaches and fatigue, were mild and resolved within the first week after dosing, and there were no serious adverse events.

Based on these findings, Dr. Schneier said controlled trials of psilocybin in BDD are warranted.
 

Need for scientific rigor

Commenting on the research, Charles B. Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, University of Texas at Austin, said while promising, psilocybin is “not for everyone” and patients need to be closely screened.

University of Texas at Austin

“We want to know their medical history and if they have a family history of schizophrenia or bipolar disorder. We don’t know whether these [psychedelic] medicines might trigger an episode.”

Dr. Nemeroff also noted there’s a risk of “troubling” side effects from the drug.

“My view is psilocybin clearly has therapeutic effects and we need to apply scientific rigor as we would any medicine in order to determine the risk/benefit ratio,” said Dr. Nemeroff, who was not associated with this psilocybin trial.

In addition, psilocybin is being tested in conditions other than BDD and major depression, including anorexia nervosa, postpartum depression, and alcohol use disorder, he added.

The study received funding from COMPASS Pathways PLC.

Dr. Nemeroff reports he has received research support from the NIH and Stanley Medical Research Institute; served as a consultant for Bracket (Clintara), Fortress Biotech, Intra-Cellular Therapies, Janssen Research and Development, Magstim, Navitor Pharmaceuticals, Sunovion Pharmaceuticals, Taisho Pharmaceuticals, Takeda, TC MSO, and Xhale; served on scientific advisory boards for the American Foundation for Suicide Prevention, the Anxiety and Depression Association of America, Bracket (Clintara), Brain and Behavior Research Foundation, Laureate Institute for Brain Research, Skyland Trail, and Xhale; is a stockholder in AbbVie, Antares, BI Gen Holdings, Celgene, OPKO Health, Seattle Genetics, and Xhale; serves on the board of directors for the American Foundation for Suicide Prevention, Anxiety and Depression Association of America, and Gratitude America; has received income or equity of $10,000 or more from American Psychiatric Publishing, Bracket (Clintara), Magstim, CME Outfitters, and Intra-Cellular Therapies; and holds patents on a method and devices for transdermal delivery of lithium and a method of assessing antidepressant drug therapy via transport inhibition of monoamine neurotransmitters by ex vivo assay.

A version of this article first appeared on Medscape.com.

Regular meditation reduced depression by roughly 44% in adults with coronary artery disease who were involved in a cardiovascular rehabilitation program.

An increasing body of research supports the impact of psychological risk factors including stress, personality type, anger, and hostility on conditions such as depression and anxiety, but also social isolation and low socioeconomic status, Ana Luisa Vitorino Monteiro, MD, of the University of Lisbon said in a presentation at the annual congress of the European Association of Preventive Cardiology. In addition, “stress, anxiety, and depression deteriorate the cardiovascular (CV) system through psycho-neuro-immunoendocrinology system and behavioral pathways.”

Meditation as a tool for stress management has been gaining popularity, but its use as part of a CV rehabilitation program as a complementary therapy has not been well studied, she added.

Dr. Monteiro and colleagues recruited 80 adults with CAD who were undergoing CV rehabilitation to join a meditation program. Of these, 48 accepted (60%) and 40% declined. Those who accepted were part of an exercise-based CV rehabilitation program that met three times a week for at least 6 months. The mean age of the participants was 65 years, and 80% were male.

Participants were randomized to an intervention group with a weekly 90-minute session that included breathing and meditation for 1 month in addition to usual care, or to usual care in the rehabilitation program. Over the next 3 months, the intervention patients were encouraged to practice daily meditation for 20 minutes alone or using video support material, with a weekly follow-up phone call. Assessments of stress, anxiety, and depression took place at baseline and after 4 months using the Perceived Stress Scale, Beck Anxiety Inventory, Beck Depression Inventory, and HeartQoL questionnaire.

At 4 months, individuals in the meditation group had reduced depression levels significantly, by 44%, compared with controls (P < .001). Anxiety and stress decreased significantly, by 30% (P = .04) and 31% (P = .05), respectively. After 4 months, individuals in the control group were offered the opportunity to follow the meditation protocol.

In addition, “the emotional dimension of quality of life increased by 60% in the intervention group,” Dr. Monteiro noted. However, physical QoL did not change between groups.

The study was limited by the small sample size, and more research is needed in larger and more diverse populations, Dr. Monteiro said. However, the results support the value of meditation as an adjunct component of care for CAD patients in a long-term rehabilitation program.
 

Motivation makes a difference

The current study is important as an exploration of “a straightforward, simple, low-risk approach that could be an adjunct to benefit patients with serious cardiovascular disease,” Brian Olshansky, MD, a cardiologist at the University of Iowa, Iowa City, said in an interview.

“We have moved into a time of polypharmacy and multiple interventions for patients with underlying cardiovascular disease which, in many cases, have proven benefit but also potential adverse effects,” he said. “Engaging patients to participate in their health care, when there is serious underlying cardiovascular disease, has potential beneficial impact in many ways. Meditation is a low-risk, low-cost, potentially beneficial adjunct to standard medical therapy that may enhance psychological outcomes as shown here in this small study.”

However, “patients often rely on high-cost, potentially high-risk therapeutic interventions, expecting complete control of their problems without their own collaborative intervention,” he noted.

Dr. Olshansky said he was not surprised by any of the findings, and would have been surprised if meditation had failed to show any benefit for the study population.

“I am very pleased to see these results and would encourage meditation practice to be part of cardiovascular rehabilitation for motivated individuals,” he said. “What did surprise me was the adherence to the meditation protocol for those who participated. This represents a highly motivated group and it may be difficult to expect the same results in less motivated individuals.”

The current study has several strengths, including the use of controls and high rates of adherence to the protocol, said Dr. Olshansky. Other strengths include the standardized approach and the reasonable quality of the outcome measures, which showed a substantial benefit.

However, “this is a small study of motivated individuals of whom 80% were male,” and generalizability to other populations is unclear, Dr. Olshansky said. In addition, the racial mix was not described, and the severity of the underlying coronary artery disease and the therapies provided to these individuals is not detailed. A sicker population may not fare as well.”

The reasons for the benefits of meditation remain uncertain, Dr. Olshansky said. “It could be, specifically, that the meditation itself has physiological effects that ultimately translate into psychosocial benefit. However, those who enrolled and were interested may have derived a placebo effect. In any case, benefit was achieved, but the crossover benefit to the control group is unclear.

“In other words, the statistical approach to benefit is uncertain as to when it was measured, but presumably before the control group was allowed to engage in a meditation practice,” and the follow-up was short term, said Dr. Olshansky.
 

Data support patient engagement

The message to clinicians and patients: “Patients should be engaged in their own health care when it comes to rehabilitation for cardiovascular disease,” said Dr. Olshansky. “Motivated individuals who are educated about a meditative practice performed in a standardized way will have improvement most likely in their quality of life, and when it comes to measurements of depression, stress and anxiety.”

Although the mechanisms behind the benefits remain unclear, “having a standardized credible prescription for which patients can become intimately engaged is beneficial,” he added.

The study received no outside funding. Neither Dr. Monteiro nor Dr. Olshansky had any financial conflicts to disclose.


 

Regular meditation reduced depression by roughly 44% in adults with coronary artery disease who were involved in a cardiovascular rehabilitation program.

An increasing body of research supports the impact of psychological risk factors including stress, personality type, anger, and hostility on conditions such as depression and anxiety, but also social isolation and low socioeconomic status, Ana Luisa Vitorino Monteiro, MD, of the University of Lisbon said in a presentation at the annual congress of the European Association of Preventive Cardiology. In addition, “stress, anxiety, and depression deteriorate the cardiovascular (CV) system through psycho-neuro-immunoendocrinology system and behavioral pathways.”

Meditation as a tool for stress management has been gaining popularity, but its use as part of a CV rehabilitation program as a complementary therapy has not been well studied, she added.

Dr. Monteiro and colleagues recruited 80 adults with CAD who were undergoing CV rehabilitation to join a meditation program. Of these, 48 accepted (60%) and 40% declined. Those who accepted were part of an exercise-based CV rehabilitation program that met three times a week for at least 6 months. The mean age of the participants was 65 years, and 80% were male.

Participants were randomized to an intervention group with a weekly 90-minute session that included breathing and meditation for 1 month in addition to usual care, or to usual care in the rehabilitation program. Over the next 3 months, the intervention patients were encouraged to practice daily meditation for 20 minutes alone or using video support material, with a weekly follow-up phone call. Assessments of stress, anxiety, and depression took place at baseline and after 4 months using the Perceived Stress Scale, Beck Anxiety Inventory, Beck Depression Inventory, and HeartQoL questionnaire.

At 4 months, individuals in the meditation group had reduced depression levels significantly, by 44%, compared with controls (P < .001). Anxiety and stress decreased significantly, by 30% (P = .04) and 31% (P = .05), respectively. After 4 months, individuals in the control group were offered the opportunity to follow the meditation protocol.

In addition, “the emotional dimension of quality of life increased by 60% in the intervention group,” Dr. Monteiro noted. However, physical QoL did not change between groups.

The study was limited by the small sample size, and more research is needed in larger and more diverse populations, Dr. Monteiro said. However, the results support the value of meditation as an adjunct component of care for CAD patients in a long-term rehabilitation program.
 

Motivation makes a difference

The current study is important as an exploration of “a straightforward, simple, low-risk approach that could be an adjunct to benefit patients with serious cardiovascular disease,” Brian Olshansky, MD, a cardiologist at the University of Iowa, Iowa City, said in an interview.

“We have moved into a time of polypharmacy and multiple interventions for patients with underlying cardiovascular disease which, in many cases, have proven benefit but also potential adverse effects,” he said. “Engaging patients to participate in their health care, when there is serious underlying cardiovascular disease, has potential beneficial impact in many ways. Meditation is a low-risk, low-cost, potentially beneficial adjunct to standard medical therapy that may enhance psychological outcomes as shown here in this small study.”

However, “patients often rely on high-cost, potentially high-risk therapeutic interventions, expecting complete control of their problems without their own collaborative intervention,” he noted.

Dr. Olshansky said he was not surprised by any of the findings, and would have been surprised if meditation had failed to show any benefit for the study population.

“I am very pleased to see these results and would encourage meditation practice to be part of cardiovascular rehabilitation for motivated individuals,” he said. “What did surprise me was the adherence to the meditation protocol for those who participated. This represents a highly motivated group and it may be difficult to expect the same results in less motivated individuals.”

The current study has several strengths, including the use of controls and high rates of adherence to the protocol, said Dr. Olshansky. Other strengths include the standardized approach and the reasonable quality of the outcome measures, which showed a substantial benefit.

However, “this is a small study of motivated individuals of whom 80% were male,” and generalizability to other populations is unclear, Dr. Olshansky said. In addition, the racial mix was not described, and the severity of the underlying coronary artery disease and the therapies provided to these individuals is not detailed. A sicker population may not fare as well.”

The reasons for the benefits of meditation remain uncertain, Dr. Olshansky said. “It could be, specifically, that the meditation itself has physiological effects that ultimately translate into psychosocial benefit. However, those who enrolled and were interested may have derived a placebo effect. In any case, benefit was achieved, but the crossover benefit to the control group is unclear.

“In other words, the statistical approach to benefit is uncertain as to when it was measured, but presumably before the control group was allowed to engage in a meditation practice,” and the follow-up was short term, said Dr. Olshansky.
 

Data support patient engagement

The message to clinicians and patients: “Patients should be engaged in their own health care when it comes to rehabilitation for cardiovascular disease,” said Dr. Olshansky. “Motivated individuals who are educated about a meditative practice performed in a standardized way will have improvement most likely in their quality of life, and when it comes to measurements of depression, stress and anxiety.”

Although the mechanisms behind the benefits remain unclear, “having a standardized credible prescription for which patients can become intimately engaged is beneficial,” he added.

The study received no outside funding. Neither Dr. Monteiro nor Dr. Olshansky had any financial conflicts to disclose.


 

Regular meditation reduced depression by roughly 44% in adults with coronary artery disease who were involved in a cardiovascular rehabilitation program.

An increasing body of research supports the impact of psychological risk factors including stress, personality type, anger, and hostility on conditions such as depression and anxiety, but also social isolation and low socioeconomic status, Ana Luisa Vitorino Monteiro, MD, of the University of Lisbon said in a presentation at the annual congress of the European Association of Preventive Cardiology. In addition, “stress, anxiety, and depression deteriorate the cardiovascular (CV) system through psycho-neuro-immunoendocrinology system and behavioral pathways.”

Meditation as a tool for stress management has been gaining popularity, but its use as part of a CV rehabilitation program as a complementary therapy has not been well studied, she added.

Dr. Monteiro and colleagues recruited 80 adults with CAD who were undergoing CV rehabilitation to join a meditation program. Of these, 48 accepted (60%) and 40% declined. Those who accepted were part of an exercise-based CV rehabilitation program that met three times a week for at least 6 months. The mean age of the participants was 65 years, and 80% were male.

Participants were randomized to an intervention group with a weekly 90-minute session that included breathing and meditation for 1 month in addition to usual care, or to usual care in the rehabilitation program. Over the next 3 months, the intervention patients were encouraged to practice daily meditation for 20 minutes alone or using video support material, with a weekly follow-up phone call. Assessments of stress, anxiety, and depression took place at baseline and after 4 months using the Perceived Stress Scale, Beck Anxiety Inventory, Beck Depression Inventory, and HeartQoL questionnaire.

At 4 months, individuals in the meditation group had reduced depression levels significantly, by 44%, compared with controls (P < .001). Anxiety and stress decreased significantly, by 30% (P = .04) and 31% (P = .05), respectively. After 4 months, individuals in the control group were offered the opportunity to follow the meditation protocol.

In addition, “the emotional dimension of quality of life increased by 60% in the intervention group,” Dr. Monteiro noted. However, physical QoL did not change between groups.

The study was limited by the small sample size, and more research is needed in larger and more diverse populations, Dr. Monteiro said. However, the results support the value of meditation as an adjunct component of care for CAD patients in a long-term rehabilitation program.
 

Motivation makes a difference

The current study is important as an exploration of “a straightforward, simple, low-risk approach that could be an adjunct to benefit patients with serious cardiovascular disease,” Brian Olshansky, MD, a cardiologist at the University of Iowa, Iowa City, said in an interview.

“We have moved into a time of polypharmacy and multiple interventions for patients with underlying cardiovascular disease which, in many cases, have proven benefit but also potential adverse effects,” he said. “Engaging patients to participate in their health care, when there is serious underlying cardiovascular disease, has potential beneficial impact in many ways. Meditation is a low-risk, low-cost, potentially beneficial adjunct to standard medical therapy that may enhance psychological outcomes as shown here in this small study.”

However, “patients often rely on high-cost, potentially high-risk therapeutic interventions, expecting complete control of their problems without their own collaborative intervention,” he noted.

Dr. Olshansky said he was not surprised by any of the findings, and would have been surprised if meditation had failed to show any benefit for the study population.

“I am very pleased to see these results and would encourage meditation practice to be part of cardiovascular rehabilitation for motivated individuals,” he said. “What did surprise me was the adherence to the meditation protocol for those who participated. This represents a highly motivated group and it may be difficult to expect the same results in less motivated individuals.”

The current study has several strengths, including the use of controls and high rates of adherence to the protocol, said Dr. Olshansky. Other strengths include the standardized approach and the reasonable quality of the outcome measures, which showed a substantial benefit.

However, “this is a small study of motivated individuals of whom 80% were male,” and generalizability to other populations is unclear, Dr. Olshansky said. In addition, the racial mix was not described, and the severity of the underlying coronary artery disease and the therapies provided to these individuals is not detailed. A sicker population may not fare as well.”

The reasons for the benefits of meditation remain uncertain, Dr. Olshansky said. “It could be, specifically, that the meditation itself has physiological effects that ultimately translate into psychosocial benefit. However, those who enrolled and were interested may have derived a placebo effect. In any case, benefit was achieved, but the crossover benefit to the control group is unclear.

“In other words, the statistical approach to benefit is uncertain as to when it was measured, but presumably before the control group was allowed to engage in a meditation practice,” and the follow-up was short term, said Dr. Olshansky.
 

Data support patient engagement

The message to clinicians and patients: “Patients should be engaged in their own health care when it comes to rehabilitation for cardiovascular disease,” said Dr. Olshansky. “Motivated individuals who are educated about a meditative practice performed in a standardized way will have improvement most likely in their quality of life, and when it comes to measurements of depression, stress and anxiety.”

Although the mechanisms behind the benefits remain unclear, “having a standardized credible prescription for which patients can become intimately engaged is beneficial,” he added.

The study received no outside funding. Neither Dr. Monteiro nor Dr. Olshansky had any financial conflicts to disclose.