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 (Aug 2024)

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

Affiliations

L.A. Morland: Department of Veterans Affairs National Center for PTSD Women's Health Sciences Division, 150 South Huntington Street, Boston, MA, 02130, USA; Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CT, 92093, USA; Corresponding author. Department of Veterans Affairs National Center for PTSD Women's Health Sciences Division, 150 South Huntington Street, Boston, MA, 02130, USA.
D. Perivoliotis: Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CT, 92093, USA
T.R. Wachsman: Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA
A. Alam: Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CT, 92093, USA
K. Knopp: Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CT, 92093, USA
C. Khalifian: Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CT, 92093, USA
D. Ramanathan: Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CT, 92093, USA
B.E. Chargin: Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA
A.W. Bismark: Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CT, 92093, USA
S. Glynn: VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, Los Angeles, CA, 90073, USA; Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, 760 Westwood Plaza, Los Angeles, CA, 90024, USA
C. Stauffer: Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA; Veterans Affairs Portland Health Care System, 3710 SW US Veterans Hospital Rd, Portland, OR, 97239, USA
A.C. Wagner: Remedy, 703 Bloor Street West, Suite 201, Toronto, Ontario, M6G 1L5, Canada; Department of Psychology, Toronto Metropolitan University, 350 Victoria St., Toronto, Ontario, M5B 2K3, Canada

Journal volume & issue: Vol. 40
p. 101314

Abstract

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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.

Published in Contemporary Clinical Trials Communications

ISSN: 2451-8654 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Medicine (General)
Website: https://www.journals.elsevier.com/contemporary-clinical-trials-communications/

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