MDMA-assisted brief cognitive behavioral conjoint therapy for PTSD: Study protocol for a pilot study.
L A Morland, D Perivoliotis, T R Wachsman, A Alam, K Knopp, C Khalifian, D Ramanathan, B E Chargin, A W Bismark, S Glynn, C Stauffer, A C Wagner
Contemporary clinical trials communications August 1, 2024 DOI: 10.1016/j.conctc.2024.101314 via PubMed
Summary
AI-generated from the abstractPTSD harms both individuals and their intimate relationships, and veteran couples face extra strain from deployment and reintegration. Cognitive-Behavioral Conjoint Therapy (CBCT) and its brief version (bCBCT) consistently reduce PTSD symptoms but have variable effects on relationship functioning. This open-label pilot study tests whether adding MDMA-assisted therapy to bCBCT improves both PTSD and relationship outcomes. Eight veterans with PTSD and their partners (16 people total) will receive bCBCT plus two MDMA sessions and two couple emotion-focused integration sessions. This is the first trial of MDMA-assisted bCBCT in U.S. military veterans and partners, aiming to develop a scalable treatment model for the VA healthcare system.
Study at a glance
| 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 |
| Citations | 4 |
| Registration | NCT05979844 |
| Key finding | 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.