Trauma-Integrated Mindfulness-Based Relapse Prevention for Women with Comorbid Post-Traumatic Stress Disorder and Substance Use Disorder: A Cluster Randomized Controlled Feasibility and Acceptability Trial.

Background: Comorbid post-traumatic stress disorder and substance use disorder (PTSD-SUD) among women receiving substance use treatment are common. Few evidence-based interventions target PTSD-SUD, however, fewer are gender responsive. Mindfulness-based relapse prevention (MBRP) has shown effectiveness for women with SUD, although it does not explicitly target PTSD. Integration of trauma-focused and gender-responsive treatments into MBRP may address the limited availability of PTSD-SUD interventions for women. This study assessed feasibility and acceptability of trauma-integrated MBRP (TI-MBRP). Methods: A single-blind computer-generated cluster-randomized design was employed in which women with PTSD-SUD ( N  = 83) received either TI-MBRP ( k  = 5) or MBRP ( k  = 5). Measures of PTSD symptom severity and craving were administered at pre-, post-, 1-, 3-, 6-, 9-, and 12-month follow-up and assessed at the individual level. Results: TI-MBRP demonstrated acceptability among participants; however, attrition was high (64%) at 12-month follow-up. Reductions in PTSD were greater in the MBRP than in the TI-MBRP group at postcourse and 1-month follow-up, and there were significant reductions in PTSD severity and craving over the 12-month period in both conditions. Conclusions: Integrating trauma- and gender-focused interventions into MBRP was feasible and acceptable. MBRP alone may be effective in reducing both PTSD and SUD symptoms in women with PTSD-SUD; however, confirmatory studies are warranted. Clinical Trial Registration Number: NCT03505749.