EPA: European Congress of Psychiatry 2021

COVID-19 and its resulting lockdowns are linked to posttraumatic stress disorder symptoms and other adverse outcomes among patients with eating disorders (EDs), two new studies show.

Courtesy Bill Branson/National Cancer Institute

Results of the first study show that patients with EDs had more stress, anxiety, depression, and PTSD-related symptoms during the lockdowns than their mentally healthy peers.

In the second study, treatment-related symptom improvement among patients with bulimia nervosa (BN) slowed following lockdown. In addition, patients with BN or anorexia nervosa (AN) experienced significant worsening of disorder-specific behaviors, including binge eating and overexercising.

Because of the strict lockdown measures introduced by the Italian government to contain the COVID-19 pandemic, “everyday life of all citizens was disrupted,” Veronica Nisticò, MS, Università Degli Studi Di Milano, who led the first study, told delegates attending the virtual European Psychiatric Association 2021 Congress.

In addition to difficulties in accessing health care, “it became difficult to go to the supermarket, to the gym, and to have the social support we were all used to,” all of which had a well-documented impact on mental health, added Ms. Nisticò, who is also affiliated with Aldo Ravelli Research Center for Neurotechnology and Experimental Brain Therapeutics.
 

Loss of control

Previous research suggests that individuals with EDs experience high levels of anxiety and an increase in binge eating, exercise, and purging behaviors, said Ms. Nisticò.

To investigate further, the researchers conducted a longitudinal study of the changes in prevalence of adverse outcomes. In the study, two assessments were conducted.

In the first assessment, conducted in April 2020, the researchers assessed 59 outpatients with EDs and 43 unaffected hospital staff and their acquaintances. The second group served as the control group.

Participants completed an online survey that included several standardized depression and anxiety scales, as well as an ad hoc survey adapted from the Eating Disorder Examination Questionnaire. This assessed changes in restrictive dieting, control over food, body image, and psychological well-being in comparison with prepandemic levels.

The results, which were also recently published online in Eating and Weight Disorders – Studies on Anorexia, Bulimia and Obesity, showed that patients with EDs experienced significantly more stress, anxiety, depression, and PTSD-related symptoms in comparison with control persons (P < .05 for all).

In addition, the investigators found that those with EDs were more fearful of losing control over their eating behavior, spent more time thinking about food and their body, and became more uncomfortable seeing their body than before the lockdown in comparison with those without EDs (P < .05).
 

Clinical implications

A second assessment, which occurred in June 2020, after lockdown restrictions were lifted, included 40 patients with EDs who had taken part in the first assessment. This time, participants were asked to compare their current eating behavior with their eating behavior during the lockdown.

Although the lifting of lockdown restrictions was associated with significant improvement in PTSD-related symptoms, the impact on stress, anxiety, and depression persisted.

These findings, said Ms. Nisticó, support the hypothesis that specific conditions that occurred during the lockdown had a direct effect on specific ED symptoms.

These findings, she added, should be considered when developing interventions for EDs in the context of individual psychotherapy and when designing large, preventive interventions.

In the second study, Eleonora Rossi, MD, psychiatric unit, department of health sciences, University of Florence (Italy), and colleagues examined the longitudinal impact of the pandemic on individuals with EDs.

They examined 74 patients with AN or BN who had undergone baseline assessments and had completed a number of questionnaires in the first months of 2019 in conjunction with being enrolled in another study.

Participants were treated with enhanced cognitive-behavioral therapy and were reevaluated between November 2019 and January 2020. They were then compared with 97 healthy individuals.
 

Bulimia patients more vulnerable

After the outbreak of the pandemic, most treatment was administered online, so patients were able to continue therapy, Dr. Rossi said during her presentation.

All participants were assessed again in April 2020, 6 weeks after the start of Italy’s lockdown.

The results, which were published in the International Journal of Eating Disorders, show that the patients with EDs “underwent a significant improvement in terms of general and eating disorder specific psychopathology” during the first treatment period, Dr. Rossi reported. In addition, among those with AN, body mass index increased significantly (P < .05 for all).

Patients with AN continued to improve during the lockdown when therapy was administered online. However, improvements that had occurred among those with BN slowed, Dr. Rossi noted.

In addition, both groups of patients with EDs experienced a worsening of their pathological eating behaviors during the lockdown, in particular, objective binge eating and compensatory physical exercise (P < .05).

“Indeed, the positive trajectory of improvement observed before lockdown was clearly interrupted during the pandemic period,” Dr. Rossi said. This could “represent a possible hint of an imminent exacerbation of the disease.”

The results also suggest that the occurrence of arguments within the household and fear regarding the safety of loved ones predicted an increase in symptoms during the lockdown, she added.

In addition, patients with BN reported more severe COVID-related PTSD symptoms than did those with AN and the control group. This increase in severity of symptoms was more prevalent among patients who had a history of childhood trauma and among those with insecure attachment, suggesting that such patients may be more vulnerable.
 

Evidence of recovery

Commenting on the studies, David Spiegel, MD, associate chair of psychiatry, Stanford (Calif.) University, noted that EDs commonly occur after physical or sexual trauma earlier in life.

“It’s a standard thing with trauma-related disorders that any other, even relatively minor, traumatic experience can exacerbate PTSD symptoms,” said Dr. Spiegel, who was not involved in the studies. In addition, the trauma of the COVID pandemic “was not minor.

“The relative isolation and the lack of outside contact may focus many people with eating disorders even more on their struggles with how they are taking care of their bodies,” said Dr. Spiegel.

“It struck me that the anorexia nervosa group were more impervious than the bulimia nervosa group, but I think that’s the case with the disorder. In some ways it’s more severe, obviously a more life-threatening disorder,” he added.

The “hopeful thing is that there seemed to be some evidence of recovery and improvement, particularly with the posttraumatic stress exacerbation, as time went on,” Dr. Spiegel said, “and that’s a good thing.”

The study authors and Dr. Spiegel reported no relevant financial relationships.

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

COVID-19 and its resulting lockdowns are linked to posttraumatic stress disorder symptoms and other adverse outcomes among patients with eating disorders (EDs), two new studies show.

Courtesy Bill Branson/National Cancer Institute

Results of the first study show that patients with EDs had more stress, anxiety, depression, and PTSD-related symptoms during the lockdowns than their mentally healthy peers.

In the second study, treatment-related symptom improvement among patients with bulimia nervosa (BN) slowed following lockdown. In addition, patients with BN or anorexia nervosa (AN) experienced significant worsening of disorder-specific behaviors, including binge eating and overexercising.

Because of the strict lockdown measures introduced by the Italian government to contain the COVID-19 pandemic, “everyday life of all citizens was disrupted,” Veronica Nisticò, MS, Università Degli Studi Di Milano, who led the first study, told delegates attending the virtual European Psychiatric Association 2021 Congress.

In addition to difficulties in accessing health care, “it became difficult to go to the supermarket, to the gym, and to have the social support we were all used to,” all of which had a well-documented impact on mental health, added Ms. Nisticò, who is also affiliated with Aldo Ravelli Research Center for Neurotechnology and Experimental Brain Therapeutics.
 

Loss of control

Previous research suggests that individuals with EDs experience high levels of anxiety and an increase in binge eating, exercise, and purging behaviors, said Ms. Nisticò.

To investigate further, the researchers conducted a longitudinal study of the changes in prevalence of adverse outcomes. In the study, two assessments were conducted.

In the first assessment, conducted in April 2020, the researchers assessed 59 outpatients with EDs and 43 unaffected hospital staff and their acquaintances. The second group served as the control group.

Participants completed an online survey that included several standardized depression and anxiety scales, as well as an ad hoc survey adapted from the Eating Disorder Examination Questionnaire. This assessed changes in restrictive dieting, control over food, body image, and psychological well-being in comparison with prepandemic levels.

The results, which were also recently published online in Eating and Weight Disorders – Studies on Anorexia, Bulimia and Obesity, showed that patients with EDs experienced significantly more stress, anxiety, depression, and PTSD-related symptoms in comparison with control persons (P < .05 for all).

In addition, the investigators found that those with EDs were more fearful of losing control over their eating behavior, spent more time thinking about food and their body, and became more uncomfortable seeing their body than before the lockdown in comparison with those without EDs (P < .05).
 

Clinical implications

A second assessment, which occurred in June 2020, after lockdown restrictions were lifted, included 40 patients with EDs who had taken part in the first assessment. This time, participants were asked to compare their current eating behavior with their eating behavior during the lockdown.

Although the lifting of lockdown restrictions was associated with significant improvement in PTSD-related symptoms, the impact on stress, anxiety, and depression persisted.

These findings, said Ms. Nisticó, support the hypothesis that specific conditions that occurred during the lockdown had a direct effect on specific ED symptoms.

These findings, she added, should be considered when developing interventions for EDs in the context of individual psychotherapy and when designing large, preventive interventions.

In the second study, Eleonora Rossi, MD, psychiatric unit, department of health sciences, University of Florence (Italy), and colleagues examined the longitudinal impact of the pandemic on individuals with EDs.

They examined 74 patients with AN or BN who had undergone baseline assessments and had completed a number of questionnaires in the first months of 2019 in conjunction with being enrolled in another study.

Participants were treated with enhanced cognitive-behavioral therapy and were reevaluated between November 2019 and January 2020. They were then compared with 97 healthy individuals.
 

Bulimia patients more vulnerable

After the outbreak of the pandemic, most treatment was administered online, so patients were able to continue therapy, Dr. Rossi said during her presentation.

All participants were assessed again in April 2020, 6 weeks after the start of Italy’s lockdown.

The results, which were published in the International Journal of Eating Disorders, show that the patients with EDs “underwent a significant improvement in terms of general and eating disorder specific psychopathology” during the first treatment period, Dr. Rossi reported. In addition, among those with AN, body mass index increased significantly (P < .05 for all).

Patients with AN continued to improve during the lockdown when therapy was administered online. However, improvements that had occurred among those with BN slowed, Dr. Rossi noted.

In addition, both groups of patients with EDs experienced a worsening of their pathological eating behaviors during the lockdown, in particular, objective binge eating and compensatory physical exercise (P < .05).

“Indeed, the positive trajectory of improvement observed before lockdown was clearly interrupted during the pandemic period,” Dr. Rossi said. This could “represent a possible hint of an imminent exacerbation of the disease.”

The results also suggest that the occurrence of arguments within the household and fear regarding the safety of loved ones predicted an increase in symptoms during the lockdown, she added.

In addition, patients with BN reported more severe COVID-related PTSD symptoms than did those with AN and the control group. This increase in severity of symptoms was more prevalent among patients who had a history of childhood trauma and among those with insecure attachment, suggesting that such patients may be more vulnerable.
 

Evidence of recovery

Commenting on the studies, David Spiegel, MD, associate chair of psychiatry, Stanford (Calif.) University, noted that EDs commonly occur after physical or sexual trauma earlier in life.

“It’s a standard thing with trauma-related disorders that any other, even relatively minor, traumatic experience can exacerbate PTSD symptoms,” said Dr. Spiegel, who was not involved in the studies. In addition, the trauma of the COVID pandemic “was not minor.

“The relative isolation and the lack of outside contact may focus many people with eating disorders even more on their struggles with how they are taking care of their bodies,” said Dr. Spiegel.

“It struck me that the anorexia nervosa group were more impervious than the bulimia nervosa group, but I think that’s the case with the disorder. In some ways it’s more severe, obviously a more life-threatening disorder,” he added.

The “hopeful thing is that there seemed to be some evidence of recovery and improvement, particularly with the posttraumatic stress exacerbation, as time went on,” Dr. Spiegel said, “and that’s a good thing.”

The study authors and Dr. Spiegel reported no relevant financial relationships.

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

COVID-19 and its resulting lockdowns are linked to posttraumatic stress disorder symptoms and other adverse outcomes among patients with eating disorders (EDs), two new studies show.

Courtesy Bill Branson/National Cancer Institute

Results of the first study show that patients with EDs had more stress, anxiety, depression, and PTSD-related symptoms during the lockdowns than their mentally healthy peers.

In the second study, treatment-related symptom improvement among patients with bulimia nervosa (BN) slowed following lockdown. In addition, patients with BN or anorexia nervosa (AN) experienced significant worsening of disorder-specific behaviors, including binge eating and overexercising.

Because of the strict lockdown measures introduced by the Italian government to contain the COVID-19 pandemic, “everyday life of all citizens was disrupted,” Veronica Nisticò, MS, Università Degli Studi Di Milano, who led the first study, told delegates attending the virtual European Psychiatric Association 2021 Congress.

In addition to difficulties in accessing health care, “it became difficult to go to the supermarket, to the gym, and to have the social support we were all used to,” all of which had a well-documented impact on mental health, added Ms. Nisticò, who is also affiliated with Aldo Ravelli Research Center for Neurotechnology and Experimental Brain Therapeutics.
 

Loss of control

Previous research suggests that individuals with EDs experience high levels of anxiety and an increase in binge eating, exercise, and purging behaviors, said Ms. Nisticò.

To investigate further, the researchers conducted a longitudinal study of the changes in prevalence of adverse outcomes. In the study, two assessments were conducted.

In the first assessment, conducted in April 2020, the researchers assessed 59 outpatients with EDs and 43 unaffected hospital staff and their acquaintances. The second group served as the control group.

Participants completed an online survey that included several standardized depression and anxiety scales, as well as an ad hoc survey adapted from the Eating Disorder Examination Questionnaire. This assessed changes in restrictive dieting, control over food, body image, and psychological well-being in comparison with prepandemic levels.

The results, which were also recently published online in Eating and Weight Disorders – Studies on Anorexia, Bulimia and Obesity, showed that patients with EDs experienced significantly more stress, anxiety, depression, and PTSD-related symptoms in comparison with control persons (P < .05 for all).

In addition, the investigators found that those with EDs were more fearful of losing control over their eating behavior, spent more time thinking about food and their body, and became more uncomfortable seeing their body than before the lockdown in comparison with those without EDs (P < .05).
 

Clinical implications

A second assessment, which occurred in June 2020, after lockdown restrictions were lifted, included 40 patients with EDs who had taken part in the first assessment. This time, participants were asked to compare their current eating behavior with their eating behavior during the lockdown.

Although the lifting of lockdown restrictions was associated with significant improvement in PTSD-related symptoms, the impact on stress, anxiety, and depression persisted.

These findings, said Ms. Nisticó, support the hypothesis that specific conditions that occurred during the lockdown had a direct effect on specific ED symptoms.

These findings, she added, should be considered when developing interventions for EDs in the context of individual psychotherapy and when designing large, preventive interventions.

In the second study, Eleonora Rossi, MD, psychiatric unit, department of health sciences, University of Florence (Italy), and colleagues examined the longitudinal impact of the pandemic on individuals with EDs.

They examined 74 patients with AN or BN who had undergone baseline assessments and had completed a number of questionnaires in the first months of 2019 in conjunction with being enrolled in another study.

Participants were treated with enhanced cognitive-behavioral therapy and were reevaluated between November 2019 and January 2020. They were then compared with 97 healthy individuals.
 

Bulimia patients more vulnerable

After the outbreak of the pandemic, most treatment was administered online, so patients were able to continue therapy, Dr. Rossi said during her presentation.

All participants were assessed again in April 2020, 6 weeks after the start of Italy’s lockdown.

The results, which were published in the International Journal of Eating Disorders, show that the patients with EDs “underwent a significant improvement in terms of general and eating disorder specific psychopathology” during the first treatment period, Dr. Rossi reported. In addition, among those with AN, body mass index increased significantly (P < .05 for all).

Patients with AN continued to improve during the lockdown when therapy was administered online. However, improvements that had occurred among those with BN slowed, Dr. Rossi noted.

In addition, both groups of patients with EDs experienced a worsening of their pathological eating behaviors during the lockdown, in particular, objective binge eating and compensatory physical exercise (P < .05).

“Indeed, the positive trajectory of improvement observed before lockdown was clearly interrupted during the pandemic period,” Dr. Rossi said. This could “represent a possible hint of an imminent exacerbation of the disease.”

The results also suggest that the occurrence of arguments within the household and fear regarding the safety of loved ones predicted an increase in symptoms during the lockdown, she added.

In addition, patients with BN reported more severe COVID-related PTSD symptoms than did those with AN and the control group. This increase in severity of symptoms was more prevalent among patients who had a history of childhood trauma and among those with insecure attachment, suggesting that such patients may be more vulnerable.
 

Evidence of recovery

Commenting on the studies, David Spiegel, MD, associate chair of psychiatry, Stanford (Calif.) University, noted that EDs commonly occur after physical or sexual trauma earlier in life.

“It’s a standard thing with trauma-related disorders that any other, even relatively minor, traumatic experience can exacerbate PTSD symptoms,” said Dr. Spiegel, who was not involved in the studies. In addition, the trauma of the COVID pandemic “was not minor.

“The relative isolation and the lack of outside contact may focus many people with eating disorders even more on their struggles with how they are taking care of their bodies,” said Dr. Spiegel.

“It struck me that the anorexia nervosa group were more impervious than the bulimia nervosa group, but I think that’s the case with the disorder. In some ways it’s more severe, obviously a more life-threatening disorder,” he added.

The “hopeful thing is that there seemed to be some evidence of recovery and improvement, particularly with the posttraumatic stress exacerbation, as time went on,” Dr. Spiegel said, “and that’s a good thing.”

The study authors and Dr. Spiegel reported no relevant financial relationships.

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

Adding 3,4-methylenedioxymethamphetamine (MDMA) to integrative psychotherapy may significantly improve symptoms and well-being for patients with severe posttraumatic stress disorder, including those with the dissociative subtype, new research suggests.

MAPP1 is the first phase 3 randomized controlled trial of MDMA-assisted therapy in this population. Participants who received the active treatment showed greater improvement in PTSD symptoms, mood, and empathy in comparison with participants who received placebo.

MDMA was “extremely effective, particularly for a subpopulation that ordinarily does not respond well to conventional treatment,” study coinvestigator Bessel van der Kolk, MD, professor of psychiatry at Boston University School of Medicine, told delegates attending the virtual European Psychiatric Association (EPA) 2021 Congress.
 

Growing interest

In recent years, there has been a great deal of interest in the potential of MDMA for the treatment of PTSD, particularly because failure rates with most available evidence-based treatments have been relatively high.

As previously reported by this news organization, in 2017, the U.S. Food and Drug Administration approved the trial design of Dr. van der Kolk’s and colleagues’ MAPP1 study after granting MDMA breakthrough designation.

The MAPP1 investigators assessed 90 patients with PTSD (mean age, 41 years; 77% White; 66% women) from 50 sites. For the majority of patients (84%), trauma history was developmental. “In other words, trauma [occurred] very early in life, usually at the hands of their own caregivers,” Dr. van der Kolk noted.

In addition, 18% of the patients were veterans, and 12% had combat exposure. The average duration of PTSD before enrollment was 18 years. All patients underwent screening and three preparatory psychotherapy sessions at enrollment.

Participants were randomly assigned to receive MDMA 80 mg or 120 mg (n = 46) or placebo (n = 44) followed by three integrative psychotherapy sessions lasting a total of 8 hours. A supplemental dose of 40 or 60 mg of MDMA could be administered from 1.5 to 2 hours after the first dose.

The patients stayed in the laboratory on the evening of the treatment session and attended a debriefing the next morning. The session was repeated a month later and again a month after that. In between, patients had telephone contact with the raters, who were blinded to the treatment received.

Follow-up assessments were conducted 2 months after the third treatment session and again at 12 months. The primary outcome measure was change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) score from baseline.
 

‘Dramatic improvement’

Results showed that both the MDMA and placebo groups experienced a statistically significant improvement in PTSD symptoms, “but MDMA had a dramatically significant improvement, with an effect size of over 0.9,” Dr. van der Kolk said.

The MDMA group also reported enhanced mood and well-being, increased responsiveness to emotional and sensory stimuli, a greater sense of closeness to other people, and a greater feeling of empathy.

Patients also reported having heightened openness, “and clearly the issue of empathy for themselves and others was a very large part of the process,” said Dr. van der Kolk.

“But for me, the most interesting part of the study is that the Adverse Childhood Experiences scale had no effect,” he noted. In other words, “the amount of childhood adverse experiences did not predict outcomes, which was very surprising because usually those patients are very treatment resistant.”

Dr. van der Kolk added that the dissociative subtype of PTSD was first described in the DSM-5 and that patients are “notoriously unresponsive to most unconventional treatments.”

In the current study, 13 patients met the criteria for the subtype, and investigators found they “did better than people with classical PTSD,” Dr. van der Kolk said. He added that this is a “very, very important finding.”
 

Carefully controlled

Overall, 82% of patients reported a significant improvement by the end of the study; 56% reported that they no longer had PTSD.

In addition, 67% of patients no longer met diagnostic criteria for PTSD. These included patients who had crossed over to active treatment from the placebo group.

Eleven patients (12%) experienced relapse by 12 months; in nine of the cases, this was due to the presence of additional stressors.

There were “very few adverse side effects” during the study, Dr. van der Kolk noted. In addition, “there were really no serious mental side effects,” despite the patients’ “opening up so much very painful material,” he added.

The most common adverse events among the MDMA group were muscle tightness (63%), decreased appetite (52%), nausea (30%), hyperhidrosis (20%), and feeling cold (20%). These effects were “quite small [and] the sort of side effects you would expect in response to an amphetamine substance like MDMA,” said Dr. van der Kolk.

“An important reason why we think the side effect profile is so good is because the study was extremely carefully done, very carefully controlled,” he added. “There was a great deal of support, [and] we paid an enormous amount of attention to creating a very safe context in which this drug was being used.”

However, he expressed concern that “as people see the very good results, they may skimp a little bit on the creation of the context and not have as careful a psychotherapy protocol as we had here.”
 

‘On the right track’

Commenting on the findings for this news organization, David Nutt, MD, PhD, Edmond J. Safra Professor of Neuropsychopharmacology, Imperial College London, said the results are proof that the investigators’ “earlier smaller trials of MDMA were on the right track.”

“This larger and multicenter trial shows that MDMA therapy can be broadened into newer research groups, which augurs well for the much larger rollout that will be required once it gets a license,” said Dr. Nutt, who was not involved with the research.

He added, “the prior evidence of the safety of MDMA has [now] been confirmed.”

The study represents an “important step in the path to the clinical use of MDMA for PTSD,” Dr. Nutt said.

The study was sponsored by the Multidisciplinary Association for Psychedelic Studies. The investigators and Dr. Nutt have reported no relevant financial relationships.

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

Adding 3,4-methylenedioxymethamphetamine (MDMA) to integrative psychotherapy may significantly improve symptoms and well-being for patients with severe posttraumatic stress disorder, including those with the dissociative subtype, new research suggests.

MAPP1 is the first phase 3 randomized controlled trial of MDMA-assisted therapy in this population. Participants who received the active treatment showed greater improvement in PTSD symptoms, mood, and empathy in comparison with participants who received placebo.

MDMA was “extremely effective, particularly for a subpopulation that ordinarily does not respond well to conventional treatment,” study coinvestigator Bessel van der Kolk, MD, professor of psychiatry at Boston University School of Medicine, told delegates attending the virtual European Psychiatric Association (EPA) 2021 Congress.
 

Growing interest

In recent years, there has been a great deal of interest in the potential of MDMA for the treatment of PTSD, particularly because failure rates with most available evidence-based treatments have been relatively high.

As previously reported by this news organization, in 2017, the U.S. Food and Drug Administration approved the trial design of Dr. van der Kolk’s and colleagues’ MAPP1 study after granting MDMA breakthrough designation.

The MAPP1 investigators assessed 90 patients with PTSD (mean age, 41 years; 77% White; 66% women) from 50 sites. For the majority of patients (84%), trauma history was developmental. “In other words, trauma [occurred] very early in life, usually at the hands of their own caregivers,” Dr. van der Kolk noted.

In addition, 18% of the patients were veterans, and 12% had combat exposure. The average duration of PTSD before enrollment was 18 years. All patients underwent screening and three preparatory psychotherapy sessions at enrollment.

Participants were randomly assigned to receive MDMA 80 mg or 120 mg (n = 46) or placebo (n = 44) followed by three integrative psychotherapy sessions lasting a total of 8 hours. A supplemental dose of 40 or 60 mg of MDMA could be administered from 1.5 to 2 hours after the first dose.

The patients stayed in the laboratory on the evening of the treatment session and attended a debriefing the next morning. The session was repeated a month later and again a month after that. In between, patients had telephone contact with the raters, who were blinded to the treatment received.

Follow-up assessments were conducted 2 months after the third treatment session and again at 12 months. The primary outcome measure was change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) score from baseline.
 

‘Dramatic improvement’

Results showed that both the MDMA and placebo groups experienced a statistically significant improvement in PTSD symptoms, “but MDMA had a dramatically significant improvement, with an effect size of over 0.9,” Dr. van der Kolk said.

The MDMA group also reported enhanced mood and well-being, increased responsiveness to emotional and sensory stimuli, a greater sense of closeness to other people, and a greater feeling of empathy.

Patients also reported having heightened openness, “and clearly the issue of empathy for themselves and others was a very large part of the process,” said Dr. van der Kolk.

“But for me, the most interesting part of the study is that the Adverse Childhood Experiences scale had no effect,” he noted. In other words, “the amount of childhood adverse experiences did not predict outcomes, which was very surprising because usually those patients are very treatment resistant.”

Dr. van der Kolk added that the dissociative subtype of PTSD was first described in the DSM-5 and that patients are “notoriously unresponsive to most unconventional treatments.”

In the current study, 13 patients met the criteria for the subtype, and investigators found they “did better than people with classical PTSD,” Dr. van der Kolk said. He added that this is a “very, very important finding.”
 

Carefully controlled

Overall, 82% of patients reported a significant improvement by the end of the study; 56% reported that they no longer had PTSD.

In addition, 67% of patients no longer met diagnostic criteria for PTSD. These included patients who had crossed over to active treatment from the placebo group.

Eleven patients (12%) experienced relapse by 12 months; in nine of the cases, this was due to the presence of additional stressors.

There were “very few adverse side effects” during the study, Dr. van der Kolk noted. In addition, “there were really no serious mental side effects,” despite the patients’ “opening up so much very painful material,” he added.

The most common adverse events among the MDMA group were muscle tightness (63%), decreased appetite (52%), nausea (30%), hyperhidrosis (20%), and feeling cold (20%). These effects were “quite small [and] the sort of side effects you would expect in response to an amphetamine substance like MDMA,” said Dr. van der Kolk.

“An important reason why we think the side effect profile is so good is because the study was extremely carefully done, very carefully controlled,” he added. “There was a great deal of support, [and] we paid an enormous amount of attention to creating a very safe context in which this drug was being used.”

However, he expressed concern that “as people see the very good results, they may skimp a little bit on the creation of the context and not have as careful a psychotherapy protocol as we had here.”
 

‘On the right track’

Commenting on the findings for this news organization, David Nutt, MD, PhD, Edmond J. Safra Professor of Neuropsychopharmacology, Imperial College London, said the results are proof that the investigators’ “earlier smaller trials of MDMA were on the right track.”

“This larger and multicenter trial shows that MDMA therapy can be broadened into newer research groups, which augurs well for the much larger rollout that will be required once it gets a license,” said Dr. Nutt, who was not involved with the research.

He added, “the prior evidence of the safety of MDMA has [now] been confirmed.”

The study represents an “important step in the path to the clinical use of MDMA for PTSD,” Dr. Nutt said.

The study was sponsored by the Multidisciplinary Association for Psychedelic Studies. The investigators and Dr. Nutt have reported no relevant financial relationships.

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

Adding 3,4-methylenedioxymethamphetamine (MDMA) to integrative psychotherapy may significantly improve symptoms and well-being for patients with severe posttraumatic stress disorder, including those with the dissociative subtype, new research suggests.

MAPP1 is the first phase 3 randomized controlled trial of MDMA-assisted therapy in this population. Participants who received the active treatment showed greater improvement in PTSD symptoms, mood, and empathy in comparison with participants who received placebo.

MDMA was “extremely effective, particularly for a subpopulation that ordinarily does not respond well to conventional treatment,” study coinvestigator Bessel van der Kolk, MD, professor of psychiatry at Boston University School of Medicine, told delegates attending the virtual European Psychiatric Association (EPA) 2021 Congress.
 

Growing interest

In recent years, there has been a great deal of interest in the potential of MDMA for the treatment of PTSD, particularly because failure rates with most available evidence-based treatments have been relatively high.

As previously reported by this news organization, in 2017, the U.S. Food and Drug Administration approved the trial design of Dr. van der Kolk’s and colleagues’ MAPP1 study after granting MDMA breakthrough designation.

The MAPP1 investigators assessed 90 patients with PTSD (mean age, 41 years; 77% White; 66% women) from 50 sites. For the majority of patients (84%), trauma history was developmental. “In other words, trauma [occurred] very early in life, usually at the hands of their own caregivers,” Dr. van der Kolk noted.

In addition, 18% of the patients were veterans, and 12% had combat exposure. The average duration of PTSD before enrollment was 18 years. All patients underwent screening and three preparatory psychotherapy sessions at enrollment.

Participants were randomly assigned to receive MDMA 80 mg or 120 mg (n = 46) or placebo (n = 44) followed by three integrative psychotherapy sessions lasting a total of 8 hours. A supplemental dose of 40 or 60 mg of MDMA could be administered from 1.5 to 2 hours after the first dose.

The patients stayed in the laboratory on the evening of the treatment session and attended a debriefing the next morning. The session was repeated a month later and again a month after that. In between, patients had telephone contact with the raters, who were blinded to the treatment received.

Follow-up assessments were conducted 2 months after the third treatment session and again at 12 months. The primary outcome measure was change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) score from baseline.
 

‘Dramatic improvement’

Results showed that both the MDMA and placebo groups experienced a statistically significant improvement in PTSD symptoms, “but MDMA had a dramatically significant improvement, with an effect size of over 0.9,” Dr. van der Kolk said.

The MDMA group also reported enhanced mood and well-being, increased responsiveness to emotional and sensory stimuli, a greater sense of closeness to other people, and a greater feeling of empathy.

Patients also reported having heightened openness, “and clearly the issue of empathy for themselves and others was a very large part of the process,” said Dr. van der Kolk.

“But for me, the most interesting part of the study is that the Adverse Childhood Experiences scale had no effect,” he noted. In other words, “the amount of childhood adverse experiences did not predict outcomes, which was very surprising because usually those patients are very treatment resistant.”

Dr. van der Kolk added that the dissociative subtype of PTSD was first described in the DSM-5 and that patients are “notoriously unresponsive to most unconventional treatments.”

In the current study, 13 patients met the criteria for the subtype, and investigators found they “did better than people with classical PTSD,” Dr. van der Kolk said. He added that this is a “very, very important finding.”
 

Carefully controlled

Overall, 82% of patients reported a significant improvement by the end of the study; 56% reported that they no longer had PTSD.

In addition, 67% of patients no longer met diagnostic criteria for PTSD. These included patients who had crossed over to active treatment from the placebo group.

Eleven patients (12%) experienced relapse by 12 months; in nine of the cases, this was due to the presence of additional stressors.

There were “very few adverse side effects” during the study, Dr. van der Kolk noted. In addition, “there were really no serious mental side effects,” despite the patients’ “opening up so much very painful material,” he added.

The most common adverse events among the MDMA group were muscle tightness (63%), decreased appetite (52%), nausea (30%), hyperhidrosis (20%), and feeling cold (20%). These effects were “quite small [and] the sort of side effects you would expect in response to an amphetamine substance like MDMA,” said Dr. van der Kolk.

“An important reason why we think the side effect profile is so good is because the study was extremely carefully done, very carefully controlled,” he added. “There was a great deal of support, [and] we paid an enormous amount of attention to creating a very safe context in which this drug was being used.”

However, he expressed concern that “as people see the very good results, they may skimp a little bit on the creation of the context and not have as careful a psychotherapy protocol as we had here.”
 

‘On the right track’

Commenting on the findings for this news organization, David Nutt, MD, PhD, Edmond J. Safra Professor of Neuropsychopharmacology, Imperial College London, said the results are proof that the investigators’ “earlier smaller trials of MDMA were on the right track.”

“This larger and multicenter trial shows that MDMA therapy can be broadened into newer research groups, which augurs well for the much larger rollout that will be required once it gets a license,” said Dr. Nutt, who was not involved with the research.

He added, “the prior evidence of the safety of MDMA has [now] been confirmed.”

The study represents an “important step in the path to the clinical use of MDMA for PTSD,” Dr. Nutt said.

The study was sponsored by the Multidisciplinary Association for Psychedelic Studies. The investigators and Dr. Nutt have reported no relevant financial relationships.

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

The World Psychiatric Association (WPA) has released new global telemedicine guidelines.

Prompted by the worldwide explosion of interest in telepsychiatry driven by the COVID-19 pandemic, the guidelines emphasize the need for international collaboration in psychiatry.

“Global teamwork is the light at the end of the tunnel” of the current crisis, lead author Davor Mucic, MD, The Little Prince Treatment Center, Copenhagen, told meeting attendees.

“Now is the time to build a user-friendly digital health care system that can better meet the inevitable future challenges,” Dr. Mucic said. “The hope is that WPA’s global guidelines for telepsychiatry can help us to move forward.”

The guidelines, which also address concerns over data security and device intercompatibility, were presented at the virtual European Psychiatric Association (EPA) 2021 Congress.
 

Breaking down barriers

Although telepsychiatry has been around since 1959, only with the rapid technologic advances of the past decade has it become available to the majority of psychiatric patients, Dr. Mucic noted.

“Unfortunately, regulatory constraints, in combination with clinicians’ concerns, kept telepsychiatry from being widely adopted and implemented prior to the current COVID-19 pandemic,” he added.

Concerns have been with regard to data safety, reimbursement for consultations, quality of care, lack of technical experience, and difficulties in changing routines.

For many clinicians, the pandemic was the “first time they used telepsychiatry, and very few have received training in how to do it,” Dr. Mucic said.

He pointed out that guidelines are available in the United States, Canada, Australia, and India, including the 2018 Best Practices in Videoconferencing-Based Telemental Health, released by the American Psychiatric Association and the American Telemedicine Association.

Dr. Mucic noted that because these documents are relevant and useful, clinicians may wonder, “Why do we need another set of guidelines?”

He explained that the current WPA guidelines outline universal recommendations that apply “regardless of local or regional regulations.” Therefore, they can be used just as easily in low- and middle-income countries as in countries where telepsychiatry is already established.
 

A new paradigm

Similar to other guidelines, the WPA’s guidelines discuss legal and regulatory requirements, informed consent, billing and reimbursement, patient selection, clinician training, the clinical setting, and more.

However, what makes the new document “so new and special” is that it opens the door to “some new and previously undiscussed aspects of telepsychiatry ... that are capable of changing the whole delivery of mental health care,” Dr. Mucic said.

The first of these new aspects is in regard to cross-cultural telepsychiatry. The goal is to eliminate the need for interpreters or competency in a different language for patients who do not speak the host country’s language by connecting them remotely with a bilingual health care professional who shares their cultural or ethnic background.

This “ethnic matching” model may lead to a “more precise and detailed symptomatology,” the authors note. They add that minimizing the risk for misinterpretation and misunderstanding can enable better diagnosis and treatment.

The second area highlighted by Dr. Mucic is in regard to international telepsychiatry; the technology could be used to obtain a second opinion from colleagues who share the relevant cultural and linguistic background.

“Further, international expertise may be brought via [telepsychiatry] to local health workers as a part of education, supervision, and scientific collaboration,” he said.

“The hope is the guidelines will pave the way for improved international collaboration, not only by clinicians but also by policymakers.”
 

A blended future?

Also at EPA 2021, two experts debated whether the COVID-19 pandemic represented a turning point for e-health in psychiatry.

Taking the pro stance, Heleen Riper, PhD, professor of eMental-Health at the Vrije Universiteit Amsterdam, argued that the future is likely to blend face-to-face interaction with video conferencing.

She believes that to maintain current progress, the focus should be on treatment personalization, engagement, and improvement, rather than cost-effectiveness.

Hans-Jürgen Möller, MD, professor emeritus, department of psychiatry, Ludwig-Maximilians-University, Munich, argued against the idea that e-health represented a turning point in psychiatry. He noted that a survey of German psychotherapists indicated that there have been a number of drawbacks to video sessions during the pandemic.

Cautious optimism

Session chair Judit Simon, MD, DPhil, professor of health economics, Medical University of Vienna, asked the debaters whether video interventions will continue to replace in-person interventions once the pandemic is over or whether things will return to “where we were prepandemic.”

Dr. Riper said she did not believe that clinicians will return completely to in-patient practice. However, she emphasized the need for training and the development of new skills to improve the therapeutic relationship with patients.

Although Dr. Riper believes there is still a need for in-person doctor/patient interactions, “we will never get back to the pre-COVID phase, both in terms of diagnostics and treatment,” she said.

Dr. Möller added that although he has “some reservations” regarding the adoption of technologies by older patients and the lack of long-term data on telepsychiatry, he partially shares Dr. Riper’s optimism.

He suggested that there is an opportunity in psychiatry to use video conferencing for multidisciplinary team meetings similar to those seen in oncology.

This would allow discussion of patient diagnosis and treatment and would enable experts in mental health to help clinicians in other specialties. For example, it could help a general practitioner differentiate between depression and a depressive phase of schizophrenia, Dr. Riper said.

The presenters have disclosed no relevant financial relationships.

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

The World Psychiatric Association (WPA) has released new global telemedicine guidelines.

Prompted by the worldwide explosion of interest in telepsychiatry driven by the COVID-19 pandemic, the guidelines emphasize the need for international collaboration in psychiatry.

“Global teamwork is the light at the end of the tunnel” of the current crisis, lead author Davor Mucic, MD, The Little Prince Treatment Center, Copenhagen, told meeting attendees.

“Now is the time to build a user-friendly digital health care system that can better meet the inevitable future challenges,” Dr. Mucic said. “The hope is that WPA’s global guidelines for telepsychiatry can help us to move forward.”

The guidelines, which also address concerns over data security and device intercompatibility, were presented at the virtual European Psychiatric Association (EPA) 2021 Congress.
 

Breaking down barriers

Although telepsychiatry has been around since 1959, only with the rapid technologic advances of the past decade has it become available to the majority of psychiatric patients, Dr. Mucic noted.

“Unfortunately, regulatory constraints, in combination with clinicians’ concerns, kept telepsychiatry from being widely adopted and implemented prior to the current COVID-19 pandemic,” he added.

Concerns have been with regard to data safety, reimbursement for consultations, quality of care, lack of technical experience, and difficulties in changing routines.

For many clinicians, the pandemic was the “first time they used telepsychiatry, and very few have received training in how to do it,” Dr. Mucic said.

He pointed out that guidelines are available in the United States, Canada, Australia, and India, including the 2018 Best Practices in Videoconferencing-Based Telemental Health, released by the American Psychiatric Association and the American Telemedicine Association.

Dr. Mucic noted that because these documents are relevant and useful, clinicians may wonder, “Why do we need another set of guidelines?”

He explained that the current WPA guidelines outline universal recommendations that apply “regardless of local or regional regulations.” Therefore, they can be used just as easily in low- and middle-income countries as in countries where telepsychiatry is already established.
 

A new paradigm

Similar to other guidelines, the WPA’s guidelines discuss legal and regulatory requirements, informed consent, billing and reimbursement, patient selection, clinician training, the clinical setting, and more.

However, what makes the new document “so new and special” is that it opens the door to “some new and previously undiscussed aspects of telepsychiatry ... that are capable of changing the whole delivery of mental health care,” Dr. Mucic said.

The first of these new aspects is in regard to cross-cultural telepsychiatry. The goal is to eliminate the need for interpreters or competency in a different language for patients who do not speak the host country’s language by connecting them remotely with a bilingual health care professional who shares their cultural or ethnic background.

This “ethnic matching” model may lead to a “more precise and detailed symptomatology,” the authors note. They add that minimizing the risk for misinterpretation and misunderstanding can enable better diagnosis and treatment.

The second area highlighted by Dr. Mucic is in regard to international telepsychiatry; the technology could be used to obtain a second opinion from colleagues who share the relevant cultural and linguistic background.

“Further, international expertise may be brought via [telepsychiatry] to local health workers as a part of education, supervision, and scientific collaboration,” he said.

“The hope is the guidelines will pave the way for improved international collaboration, not only by clinicians but also by policymakers.”
 

A blended future?

Also at EPA 2021, two experts debated whether the COVID-19 pandemic represented a turning point for e-health in psychiatry.

Taking the pro stance, Heleen Riper, PhD, professor of eMental-Health at the Vrije Universiteit Amsterdam, argued that the future is likely to blend face-to-face interaction with video conferencing.

She believes that to maintain current progress, the focus should be on treatment personalization, engagement, and improvement, rather than cost-effectiveness.

Hans-Jürgen Möller, MD, professor emeritus, department of psychiatry, Ludwig-Maximilians-University, Munich, argued against the idea that e-health represented a turning point in psychiatry. He noted that a survey of German psychotherapists indicated that there have been a number of drawbacks to video sessions during the pandemic.

Cautious optimism

Session chair Judit Simon, MD, DPhil, professor of health economics, Medical University of Vienna, asked the debaters whether video interventions will continue to replace in-person interventions once the pandemic is over or whether things will return to “where we were prepandemic.”

Dr. Riper said she did not believe that clinicians will return completely to in-patient practice. However, she emphasized the need for training and the development of new skills to improve the therapeutic relationship with patients.

Although Dr. Riper believes there is still a need for in-person doctor/patient interactions, “we will never get back to the pre-COVID phase, both in terms of diagnostics and treatment,” she said.

Dr. Möller added that although he has “some reservations” regarding the adoption of technologies by older patients and the lack of long-term data on telepsychiatry, he partially shares Dr. Riper’s optimism.

He suggested that there is an opportunity in psychiatry to use video conferencing for multidisciplinary team meetings similar to those seen in oncology.

This would allow discussion of patient diagnosis and treatment and would enable experts in mental health to help clinicians in other specialties. For example, it could help a general practitioner differentiate between depression and a depressive phase of schizophrenia, Dr. Riper said.

The presenters have disclosed no relevant financial relationships.

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

The World Psychiatric Association (WPA) has released new global telemedicine guidelines.

Prompted by the worldwide explosion of interest in telepsychiatry driven by the COVID-19 pandemic, the guidelines emphasize the need for international collaboration in psychiatry.

“Global teamwork is the light at the end of the tunnel” of the current crisis, lead author Davor Mucic, MD, The Little Prince Treatment Center, Copenhagen, told meeting attendees.

“Now is the time to build a user-friendly digital health care system that can better meet the inevitable future challenges,” Dr. Mucic said. “The hope is that WPA’s global guidelines for telepsychiatry can help us to move forward.”

The guidelines, which also address concerns over data security and device intercompatibility, were presented at the virtual European Psychiatric Association (EPA) 2021 Congress.
 

Breaking down barriers

Although telepsychiatry has been around since 1959, only with the rapid technologic advances of the past decade has it become available to the majority of psychiatric patients, Dr. Mucic noted.

“Unfortunately, regulatory constraints, in combination with clinicians’ concerns, kept telepsychiatry from being widely adopted and implemented prior to the current COVID-19 pandemic,” he added.

Concerns have been with regard to data safety, reimbursement for consultations, quality of care, lack of technical experience, and difficulties in changing routines.

For many clinicians, the pandemic was the “first time they used telepsychiatry, and very few have received training in how to do it,” Dr. Mucic said.

He pointed out that guidelines are available in the United States, Canada, Australia, and India, including the 2018 Best Practices in Videoconferencing-Based Telemental Health, released by the American Psychiatric Association and the American Telemedicine Association.

Dr. Mucic noted that because these documents are relevant and useful, clinicians may wonder, “Why do we need another set of guidelines?”

He explained that the current WPA guidelines outline universal recommendations that apply “regardless of local or regional regulations.” Therefore, they can be used just as easily in low- and middle-income countries as in countries where telepsychiatry is already established.
 

A new paradigm

Similar to other guidelines, the WPA’s guidelines discuss legal and regulatory requirements, informed consent, billing and reimbursement, patient selection, clinician training, the clinical setting, and more.

However, what makes the new document “so new and special” is that it opens the door to “some new and previously undiscussed aspects of telepsychiatry ... that are capable of changing the whole delivery of mental health care,” Dr. Mucic said.

The first of these new aspects is in regard to cross-cultural telepsychiatry. The goal is to eliminate the need for interpreters or competency in a different language for patients who do not speak the host country’s language by connecting them remotely with a bilingual health care professional who shares their cultural or ethnic background.

This “ethnic matching” model may lead to a “more precise and detailed symptomatology,” the authors note. They add that minimizing the risk for misinterpretation and misunderstanding can enable better diagnosis and treatment.

The second area highlighted by Dr. Mucic is in regard to international telepsychiatry; the technology could be used to obtain a second opinion from colleagues who share the relevant cultural and linguistic background.

“Further, international expertise may be brought via [telepsychiatry] to local health workers as a part of education, supervision, and scientific collaboration,” he said.

“The hope is the guidelines will pave the way for improved international collaboration, not only by clinicians but also by policymakers.”
 

A blended future?

Also at EPA 2021, two experts debated whether the COVID-19 pandemic represented a turning point for e-health in psychiatry.

Taking the pro stance, Heleen Riper, PhD, professor of eMental-Health at the Vrije Universiteit Amsterdam, argued that the future is likely to blend face-to-face interaction with video conferencing.

She believes that to maintain current progress, the focus should be on treatment personalization, engagement, and improvement, rather than cost-effectiveness.

Hans-Jürgen Möller, MD, professor emeritus, department of psychiatry, Ludwig-Maximilians-University, Munich, argued against the idea that e-health represented a turning point in psychiatry. He noted that a survey of German psychotherapists indicated that there have been a number of drawbacks to video sessions during the pandemic.

Cautious optimism

Session chair Judit Simon, MD, DPhil, professor of health economics, Medical University of Vienna, asked the debaters whether video interventions will continue to replace in-person interventions once the pandemic is over or whether things will return to “where we were prepandemic.”

Dr. Riper said she did not believe that clinicians will return completely to in-patient practice. However, she emphasized the need for training and the development of new skills to improve the therapeutic relationship with patients.

Although Dr. Riper believes there is still a need for in-person doctor/patient interactions, “we will never get back to the pre-COVID phase, both in terms of diagnostics and treatment,” she said.

Dr. Möller added that although he has “some reservations” regarding the adoption of technologies by older patients and the lack of long-term data on telepsychiatry, he partially shares Dr. Riper’s optimism.

He suggested that there is an opportunity in psychiatry to use video conferencing for multidisciplinary team meetings similar to those seen in oncology.

This would allow discussion of patient diagnosis and treatment and would enable experts in mental health to help clinicians in other specialties. For example, it could help a general practitioner differentiate between depression and a depressive phase of schizophrenia, Dr. Riper said.

The presenters have disclosed no relevant financial relationships.

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