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MDMA-assisted brief cognitive behavioral conjoint therapy for PTSD: Study protocol for a pilot study.

Leslie A. Morland, Dimitri Perivoliotis, Tamara R Wachsman, A Alam, Kayla Knopp, Chandra Khalifian, Dhakshin Ramanathan, Bettye E Chargin, Andrew W. Bismark, S Glynn, C Stauffer, A C Wagner

Contemporary Clinical Trials Communications August 1, 2024 DOI: 10.1016/j.conctc.2024.101314 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Single site, open-label study Pilot study Peer reviewed
Sample size 16
Population U.S. military veterans with PTSD and their intimate partners
Interventions MDMA-assisted therapy couple emotion focused integration sessions
Topics MDMA PTSD
Keywords Intimate relationships PTSD Treatment Couples therapy Psychedelic medicine Veterans mental health Trauma healing
Citations 4
Registration NCT05979844
Key points This is a protocol description; no results are reported.

Abstract

Posttraumatic Stress Disorder (PTSD) impacts both individual and relational functioning. Veteran couples are at increased risk of relationship distress due to military stressors such as deployment, family reintegration, and traumatic stress. Although both Cognitive-Behavioral Conjoint Therapy (CBCT) and its brief version (bCBCT) consistently have large effects on reducing PTSD symptoms, these treatments have more variable effects on relational outcomes. Given the impact of relationship functioning on the overall health of veterans, improving the effect of PTSD treatments on relationship functioning is an essential area of research. One promising path is the role of MDMA (3,4-methylenedioxymethamphetamine)-assisted therapy in augmenting the relational impact of established therapeutic interventions such as bCBCT. This is a single site, open-label study assessing the preliminary efficacy, safety, and acceptability of MDMA-assisted therapy in combination with bCBCT in 8 veterans with PTSD and their intimate partners (N = 16). Therapy teams trained in bCBCT and MDMA-assisted therapy will deliver bCBCT combined with two MDMA sessions and two couple emotion focused integration sessions. PTSD symptom severity and relationship functioning outcomes will be evaluated. This is the first study to examine the efficacy of MDMA-assisted bCBCT for improving PTSD and relationship functioning among a sample of U.S. military veterans and their partners. This project could provide an opportunity to pilot a scalable model of treating PTSD within the Veterans Affairs healthcare system and leverage the benefits of MDMA for veterans with PTSD, as well as the downstream benefits to their partner on both individual and relationship functioning. ClinicalTrials.gov Identifier: NCT05979844.

Comparable studies

Other non-randomized and open-label trials on MDMA for PTSD, most cited first.

Study Year Design Participants
Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study. Adults with chronic, treatment-resistant PTSD 2013 Long-term follow-up of a completed trial n = 19
MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial. Couples in which one partner was diagnosed with PTSD 2020 Pilot study n = 6
Culturally informed research design issues in a study for MDMA-assisted psychotherapy for posttraumatic stress disorder People of color with posttraumatic stress disorder 2019 Phase 2 open-label multisite study
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil. Patients with PTSD secondary to sexual abuse 2021 Open-label clinical trial n = 3
Relational and Growth Outcomes Following Couples Therapy With MDMA for PTSD. Romantic dyads where one partner had PTSD 2021 Pilot trial n = 6

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