Rationale, design, and implementation of a clinical trial of a mindfulness-based relapse prevention protocol for the treatment of women with comorbid post traumatic stress disorder and substance use disorder.

Comorbid post-traumatic stress disorder (PTSD) and substance use disorders (SUD) commonly co-occur and is associated with a more complex clinical presentation with poorer clinical outcomes when compared with either disorder alone, and untreated PTSD can predict relapse to substance abuse. A number of integrated treatment approaches addressing symptoms of both PTSD and SUD concurrently demonstrate that both disorders can safely and effectively be treated concurrently. However, attrition and SUD relapse rates remain high and there is need to further develop new treatment approaches. Innovative approaches such as mindfulness meditation (MM) successfully used in the treatment of SUD may offer additional benefits for individuals with SUD complicated with PTSD. Specifically, Mindfulness-based Relapse Prevention (MBRP) integrates coping skills from cognitive-behavioral relapse prevention therapy with MM practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses. Here we present the design and methods for the "Mindfulness Meditation for the Treatment of Women with comorbid PTSD and SUD" study, a Stage 1b behavioral development study that modifies MBRP treatment to address both PTSD and SUD in a community setting. This study is divided into three parts: revising the existing evidence-based manual, piloting the intervention, and testing the new manual in a randomized controlled pilot trial in women with comorbid PTSD and SUD enrolled in a community-based SUD treatment program.