Posttraumatic Stress Disorder Intervention for People with Severe Mental Illness in a Low-Income Country Primary Care Setting: A Randomized Feasibility Trial Protocol

Abstract

BackgroundIn 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. MethodsSpecifically, 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, one-month follow-up, and three-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. DiscussionFindings 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 RegistrationRegistered with ClinicalTrials.gov (NCT04385498) first posted May 13th, 2020; https://www.clinicaltrials.gov/ct2/show/NCT04385498?term=ethiopia&cond=PTSD&draw=2&rank=1.

A culturally adapted brief intervention for post-traumatic stress disorder in people with severe mental illness in Botswana: protocol for a randomised feasibility trial

“…The instrument has been used in studies conducted in Southern Africa including South Africa [29,30] and Zimbabwe [31]. Additional items developed from findings of a survey amongst an Ethiopian population with SMI [32] will be added to the LEC and edited as new items emerge during the interviews. Examples of the additional items include the following: someone restrained, chained or forced to be alone or isolated; exploitation, such as property being stolen, or someone intentionally not being paid for work.…”

“…The event could have happened to you or a close family member or friend, or you could have witnessed it happening to someone else). The LEC-5 [27] with additional items [32] and the CTQ-SF [23] will be used to guide the interviews on potentially traumatic experiences that participants may have been exposed to. We will utilise some of the screening questions from the Zulu Culture Specific Trauma Experience Questionnaire (ZTEQ) to enhance understanding of culturally specific trauma experiences such as having a frightening experience which the participant believes was a result of failure to fulfil traditional rituals, displeasure by ancestors or witchcraft [33].…”