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MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial.

ABSTRACT: Cognitive-behavioural conjoint therapy (CBCT) for PTSD has been shown to improve PTSD, relationship adjustment, and the health and well-being of partners. MDMA (3,4-methylenedioxymethamphetamine) has been used to facilitate an individual therapy for PTSD. This study was an initial test of the safety, tolerability, and efficacy of MDMA-facilitated CBCT. Six couples with varying levels of baseline relationship satisfaction in which one partner was diagnosed with PTSD participated in a condensed version of the 15-session CBCT protocol delivered over 7 weeks. There were two sessions in which both members of the couple were administered MDMA. All couples completed the treatment protocol, and there were no serious adverse events in either partner. There were significant improvements in clinician-assessed, patient-rated, and partner-rated PTSD symptoms (pre- to post-treatment/follow-up effect sizes ranged from d = 1.85-3.59), as well as patient depression, sleep, emotion regulation, and trauma-related beliefs. In addition, there were significant improvements in patient and partner-rated relationship adjustment and happiness (d =.64-2.79). These results are contextualized in relation to prior results from individual MDMA-facilitated psychotherapy and CBCT for PTSD alone. MDMA holds promise as a facilitator of CBCT to achieve more robust and broad effects on individual and relational functioning in those with PTSD and their partners.

SUBMITTER: Monson CM

PROVIDER: S-EPMC7748057 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial.

Monson Candice M CM Wagner Anne C AC Mithoefer Ann T AT Liebman Rachel E RE Feduccia Allison A AA Jerome Lisa L Yazar-Klosinski Berra B Emerson Amy A Doblin Rick R Mithoefer Michael C MC

European journal of psychotraumatology 20201207 1

Cognitive-behavioural conjoint therapy (CBCT) for PTSD has been shown to improve PTSD, relationship adjustment, and the health and well-being of partners. MDMA (3,4-methylenedioxymethamphetamine) has been used to facilitate an individual therapy for PTSD. This study was an initial test of the safety, tolerability, and efficacy of MDMA-facilitated CBCT. Six couples with varying levels of baseline relationship satisfaction in which one partner was diagnosed with PTSD participated in a condensed ve ...[more]

PMID: 33408811

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Project description:ImportanceCognitive processing therapy (CPT) is an evidence-based treatment for posttraumatic stress disorder (PTSD). However, there is little evidence on the efficacy of CPT in East Asia.ObjectiveTo evaluate whether CPT is effective in treating PTSD among outpatients in a Japanese medical setting.Design, setting, and participantsThis randomized clinical trial used a 16-week, single-center, assessor-blinded, parallel-group superiority design to examine the efficacy of CPT in conjunction with treatment as usual (CPT-TAU) vs waiting list with TAU (WL-TAU) from April 2016 through December 2022. The trial included adult patients with PTSD at a national psychiatric referral hospital in Tokyo, Japan. Analysis was based on intention to treat and per protocol and was performed from February 1 to April 30, 2024.InterventionsParticipants were randomized 1:1 to CPT-TAU (n = 29), which consisted of 12 weekly individual CPT sessions, or WL-TAU (n = 31), which consisted of clinical monitoring and/or pharmacotherapy.Main outcomes and measuresThe primary outcome was the Clinician-Administered PTSD Scale (CAPS-5) score for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) at 17 weeks. Secondary outcomes included self-reported PTSD symptoms assessed by the PTSD Checklist-5 and responder status at 17 weeks. Adverse events were evaluated using the Japanese version of the Common Terminology Criteria for Adverse Events, version 4.0.ResultsAmong 60 eligible participants (all included in the intention-to-treat analysis), mean (SD) age was 36.9 (9.9) years; 54 (90.0%) were women. The CPT-TAU group showed a mean (SE) reduction in CAPS-5 scores of 14.00 (1.92) points, with a low dropout rate (2 of 29 [6.9%]). Patients in the CPT-TAU group showed superiority in all secondary and other outcomes. The mean change difference was observed in depression (8.83; 95% CI, 6.00-11.66), suicidal ideation (6.73; 95% CI, 1.25-12.22), disability (8.16; 95% CI, 3.90-12.43), clinical global impression (0.84; 95% CI, 0.41-1.26), and loss of principal PTSD diagnosis (59.09; 95% CI, 37.19-81.00). There were no serious adverse events in the CPT-TAU group and 3 serious adverse events in the WL-TAU group during the intervention period.Conclusions and relevanceIn this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in East Asian populations.Trial registrationUmin.Uc.Jp/Ctr Identifier: UMIN000021670.

Project description:Study objectivesExamine whether cognitive behavioral therapy for insomnia (CBT-I) improves sleep in posttraumatic stress disorder (PTSD) as well as nightmares, nonsleep PTSD symptoms, depression symptoms, and psychosocial functioning.DesignRANDOMIZED CONTROLLED TRIAL WITH TWO ARMS: CBT-I and monitor-only waitlist control.SettingDepartment of Veterans Affairs (VA) Medical Center.ParticipantsForty-five adults (31 females: [mean age 37 y (22-59 y)] with PTSD meeting research diagnostic criteria for insomnia, randomly assigned to CBT-I (n = 29; 22 females) or monitor-only waitlist control (n = 16; nine females).InterventionsEight-session weekly individual CBT-I delivered by a licensed clinical psychologist or a board-certified psychiatrist.Measurements and resultsMeasures included continuous monitoring of sleep with diary and actigraphy; prepolysomnography and postpolysomnography and Clinician-Administered PTSD Scale (CAPS); and pre, mid, and post self-report questionnaires, with follow-up of CBT-I participants 6 mo later. CBT-I was superior to the waitlist control condition in all sleep diary outcomes and in polysomnography-measured total sleep time. Compared to waitlist participants, CBT-I participants reported improved subjective sleep (41% full remission versus 0%), disruptive nocturnal behaviors (based on the Pittsburgh Sleep Quality Index-Addendum), and overall work and interpersonal functioning. These effects were maintained at 6-mo follow-up. Both CBT-I and waitlist control participants reported reductions in PTSD symptoms and CAPS-measured nightmares.ConclusionsCognitive behavioral therapy for insomnia (CBT-I) improved sleep in individuals with posttraumatic stress disorder, with durable gains at 6 mo. Overall psychosocial functioning improved following CBT-I. The initial evidence regarding CBT-I and nightmares is promising but further research is needed. Results suggest that a comprehensive approach to treatment of posttraumatic stress disorder should include behavioral sleep medicine.Clinical trial informationTRIAL NAME: Cognitive Behavioral Treatment Of Insomnia In Posttraumatic Stress Disorder. URL: http://clinicaltrials.gov/ct2/show/NCT00881647.Registration numberNCT00881647.

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MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial.

Publications

MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial.

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