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

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-05-24 DOI:10.1016/j.conctc.2024.101314

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

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引用次数: 0

Abstract

Background

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.

Method/Design

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.

Conclusion

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.

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MDMA 辅助的创伤后应激障碍简短认知行为联合疗法：试点研究的研究方案

背景创伤后应激障碍（PTSD）既影响个人功能，也影响夫妻关系。退伍军人夫妇由于部署、重新融入家庭和创伤应激等军事压力因素而面临更高的关系困扰风险。虽然认知行为联合疗法（CBCT）及其简短版本（bCBCT）在减轻创伤后应激障碍症状方面效果显著，但这些疗法对夫妻关系的影响却不尽相同。鉴于关系功能对退伍军人整体健康的影响，改善创伤后应激障碍治疗对关系功能的影响是一个重要的研究领域。MDMA（3,4-亚甲二氧基甲基苯丙胺）辅助疗法在增强 bCBCT 等既有治疗干预措施的关系影响方面的作用是一条很有前景的途径。方法/设计这是一项单点、开放标签研究，旨在评估 MDMA 辅助疗法结合 bCBCT 对 8 名创伤后应激障碍退伍军人及其亲密伴侣（N = 16）的初步疗效、安全性和可接受性。接受过 bCBCT 和摇头丸辅助疗法培训的治疗小组将结合两个摇头丸疗程和两个情侣情绪集中整合疗程开展 bCBCT 治疗。将对创伤后应激障碍症状严重程度和关系功能结果进行评估。结论这是第一项在美国退伍军人及其伴侣中抽样调查 MDMA 辅助 bCBCT 对改善创伤后应激障碍和关系功能疗效的研究。该项目可为在退伍军人事务医疗保健系统内试行一种可扩展的创伤后应激障碍治疗模式提供机会，并充分利用 MDMA 对患有创伤后应激障碍的退伍军人的益处，以及对其伴侣的个人和关系功能的下游益处。ClinicalTrials.gov Identifier：NCT05979844。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.