Scaling Up: Multisite Open-Label Clinical Trials of MDMA-Assisted Therapy for Severe Posttraumatic Stress Disorder

Autor: Rebecca Matthews, Ilsa Jerome, Rick Doblin, Jessica Lin, Allison R. Coker, Julie B. Wang, Alia Lilienstein, Amy Emerson, G Marcela Ot’alora, Elizabeth Heimler, Michael C. Mithoefer, Leah Bedrosian, Berra Yazar-Klosinski, Charlotte Harrison, Shannon Carlin, Annie Mithoefer, Bruce Poulter, Allison A. Feduccia
Rok vydání: 2021
Předmět:
Zdroj: Journal of Humanistic Psychology. :002216782110236
ISSN: 1552-650X
0022-1678
DOI: 10.1177/00221678211023663
Popis: Background: Posttraumatic stress disorder (PTSD) is a debilitating mental health condition associated with serious adverse health outcomes and functional impairment. Previous MDMA–assisted therapy (MDMA-AT) studies have shown promising results in single site studies. Two open-label studies tested this modality in multisite clinical trials to assess the feasibility of scaling this manualized therapy across 14 North American sites. Method: Cotherapist dyads were trained in the manualized MDMA-AT protocol and administered three experimental sessions 3 to 5 weeks apart among participants with severe PTSD. Cotherapist dyads were provided clinical supervision and evaluated for protocol adherence by centralized raters. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) assessed change in symptoms severity. Results: Adherence rating scores were high across cotherapist dyads ( M = 95.08%, SD = 3.70%) and sites ( M = 95.23%, SD = 2.20%). CAPS-5 scores decreased following 3 MDMA-AT sessions at 18 weeks post baseline (Δ M = −29.99, Δ SD = 13.45, p < .0001, n = 37, Cohen’s d = 2.2, confidence interval [1.97, 2.47]). MDMA was well tolerated. Conclusions: These findings corroborate previous results that MDMA-AT can achieve significant improvements in PTSD symptom severity and demonstrate scalability of manualized therapy across clinic sites in the United States and Canada.
Databáze: OpenAIRE
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