A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment: A Randomized-controlled Pilot Trial

Approximately 4.7 million women in the US experience sexual and/or physical interpersonal violence (IPV) each year, and 46% experience IPV in their lifetime. More than 50% of interpersonal related violence occurs before age 25. In addition to acute, chronic and fatal injuries caused by IPV, women survivors of trauma (WST) are also at greater risk for organ and immune system diseases due to chronic stress, reproductive dysfunctions and complications during pregnancy, psychological disorders, and the inability to access health care services and social support. Estimated medical and mental health care costs for WST are $8.3 billion dollars per year, as well as $8 million dollars lost in paid workdays. Additionally, annual health care cost of survivors can persist up to 15 years after the cessation of abuse.

More than 90% of women admitted into substance use treatment settings have experienced IPV, and 30-60% meet criteria for comorbid SUD and PTSD. IPV typically precedes the onset of substance abuse as a means to cope with intense physiological, psychological, and emotional symptoms attributed to the event. Research has demonstrated that for women, PTSD symptoms may mediate the relationship between IPV and problematic SU. Women with PTSD symptoms and SUD also experience greater severity of addiction symptoms compared to men, and often readmit into treatment more frequently than men or women without traumatic histories. Evidence also suggests that PTSD symptoms and SU yields poorer treatment outcomes than any other comorbid disorder, or than SUD or PTSD alone. Due to these high rates of comorbidity and interrelationship of symptoms, particularly in women, integrated treatments targeting both substance use and trauma recovery are needed. However, few such evidence-based interventions (EBIs) are available for WST in substance use treatment settings. The few EBIs addressing SUD and trauma that are available have been mostly validated on males or specifically adapted for veteran populations. Mindfulness-Based Relapse Prevention (MBRP) is one evidence-based intervention that has demonstrated efficacy in reducing substance craving, relapse, and negative affect in a variety of SUD populations. It has also shown efficacy in incarcerated populations, ethnic minority women, and women offenders, all of which have higher levels of trauma exposure compared to normative samples. Research on Mindfulness-Based Interventions (MBIs) with trauma populations suggest that mindfulness skills can help decrease PTSD symptoms associated with avoidance and trauma-based cognitions, and that MBIs are not iatrogenic for trauma populations. A trauma informed adaptation of MBRP may thus offer an integrated intervention targeting both PTSD and SUD symptoms, and addressing the etiologies and maintaining factors underlying the comorbidity.

Given the particular needs and unique presentation of WST in substance use treatment settings, effective evidence-based interventions must be developed to improve treatment outcomes. The long-term goal of this line of research is to develop, examine and disseminate an adapted evidence-based treatment for comorbid SUD and PTSD for women survivors of trauma (WST). The primary objective of this study is to develop and evaluate an intervention that integrates trauma education and treatment approaches used in Cognitive Processing Therapy (CPT), an evidence-based intervention for PTSD, into the standard MBRP protocol to provide a trauma-informed approach to treating women in community-based substance use treatment settings. The development phase of the study will use focus groups with staff and clients from a women's residential treatment center who have completed the MBRP course to inform the integration of trauma education using the CPT manual into the MBRP protocol. Using a mixed-methods, pre-post, randomized-control design, WST (N=100) enrolled in a residential treatment program will be randomized by cluster into an experimental (TI-MBRP) or control (TAU) group to determine feasibility, acceptability, preliminary efficacy, and candidate mechanisms of TI-MBRP. To accomplish the primary objective, the following three aims are proposed:

Aim 1: Development and refinement of a Trauma Informed-Mindfulness Based Relapse Prevention (TI-MBRP) protocol. Informed by focus groups with staff and resident clients, a protocol integrating evidence-based practices for SUDs and PTSD will be developed for women in substance use treatment endorsing PTSD symptoms.

Aim 2: Determine feasibility and acceptability of TI-MBRP. Based on prior studies of MBRP in similar populations, we hypothesize TI-MBRP will be feasible and acceptable, as measured by recruitment and retention rates, weekly homework compliance, client participation in groups, and post-intervention client feedback.