A participant-randomized pilot hybrid II trial of group cognitive processing therapy for incarcerated persons with posttraumatic stress and substance use disorder symptoms: study protocol and rationale.

BACKGROUND: Trauma exposure and drug addiction go hand-in-hand for the 2.17 million people who are incarcerated in US prisons; prevalence of both exceed 80% among this population. This manuscript describes the rationale and methods for a participant-randomized effectiveness-implementation hybrid type II pilot trial designed to: 1) examine the effectiveness of Cognitive Processing Therapy group (CPT), an evidence-based psychotherapy for posttraumatic stress disorder (PTSD), for reducing post-release drug use and PTSD symptoms when adapted for and delivered in prisons; and 2) provide data on implementation outcomes associated with the use of implementation facilitation as a strategy for supporting uptake of CPT in prisons. METHOD: Participants in the effectiveness portion of the trial (N = 120) will be incarcerated men and women who are randomly assigned to one of two group therapies: CPT or a control condition (PTSD coping skills group; PCS). Participants will complete assessment measures three times: pre-treatment, post-treatment, and 3 months following release from incarceration. CPT groups will be led by prison counselors who are receiving implementation facilitation to support their efforts. PCS groups will be led by trained clinicians on the research team. Implementation outcomes will include acceptability, appropriateness, adoption, feasibility, fidelity, and sustainability. After enrollment ends, the research team will monitor CPT sustainment and recidivism outcomes of study participants for one year. DISCUSSION: This study will lay the groundwork for a larger study of interventions for co-occurring PTSD and SUD in prisons and, critically, inform the development of strategies (such as implementation facilitation) for supporting their uptake in routine practice. TRIAL REGISTRATION: NCT04007666 , clinicaltrials.gov, 24 June 2019, 02 September 2021.