Posttraumatic stress disorder intervention for people with severe mental illness in a low-income country primary care setting: a randomized feasibility trial protocol.

Background: In this protocol, we outline a mixed-methods randomized feasibility trial of Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia. BREATHE Ethiopia is a culturally and contextually adapted intervention for PTSD in participants with severe mental illness. BREATHE Ethiopia maps onto the World Health Organization's guidelines for posttraumatic stress disorder (PTSD) treatment in low- and middle-income country primary care settings.

Methods: Specifically, this study includes a non-randomized pre-pilot (n = 5) and a randomized feasibility trial comparing BREATHE Ethiopia to Treatment as Usual (n = 40) to assess trial procedures, acceptability, and feasibility of intervention delivery, and investigate potential effectiveness and implementation. In a process evaluation, we will collect data that will be critical for a future fully randomized controlled trial, including the numbers of participants who are eligible, who consent, who engage in treatment, and who complete the assessments, as well as the feasibility and acceptability of assessments and the intervention. Qualitative data on facilitators and barriers to intervention delivery and quantitative data on provider fidelity to the intervention and participant and provider satisfaction will also be collected. Quantitative assessments at baseline, post-treatment, 1-month follow-up, and 3-month follow-up will assess change in mental health symptoms and functional impairment and hypothesized intervention mechanisms, including knowledge about PTSD, stigma, trauma-related cognitions, and physiological arousal.

Discussion: Findings from this study will inform a future fully-powered randomized controlled trial, and if found to be effective, the intervention has the potential to be integrated into mental healthcare scale-up efforts in other low-resource settings.

Trial Registration: Registered with ClinicalTrials.gov (NCT04385498) first posted May 13, 2020; https://www.clinicaltrials.gov/ct2/show/NCT04385498?term=ethiopia&cond=PTSD&draw=2&rank=1 .