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

中文翻译：

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低收入国家初级保健机构中严重精神疾病患者的创伤后应激障碍干预：随机可行性试验方案

在本协议中，我们概述了埃塞俄比亚的简短放松、教育和创伤治疗 (BREATHE) 的混合方法随机可行性试验。BREATHE 埃塞俄比亚是一种针对患有严重精神疾病的参与者的 PTSD 的文化和背景适应性干预。BREATHE 埃塞俄比亚映射到世界卫生组织在低收入和中等收入国家初级保健机构中的创伤后应激障碍 (PTSD) 治疗指南。具体来说，本研究包括一项非随机预试验 (n = 5) 和一项比较 BREATHE 埃塞俄比亚与常规治疗 (n = 40) 的随机可行性试验，以评估试验程序、可接受性和干预实施的可行性，并调查潜在的有效性和实施。在过程评估中，我们将收集对未来完全随机对照试验至关重要的数据，包括符合条件的参与者人数、同意的参与者、参与治疗的参与者和完成评估的参与者，以及评估的可行性和可接受性，以及干涉。还将收集有关干预实施的促进者和障碍的定性数据以及提供者对干预的忠诚度以及参与者和提供者满意度的定量数据。基线、治疗后、1 个月随访和 3 个月随访的定量评估将评估心理健康症状和功能障碍的变化以及假设的干预机制，包括有关 PTSD、耻辱感、创伤相关认知、和生理唤醒。这项研究的结果将为未来的全功率随机对照试验提供信息，如果发现有效，该干预有可能被整合到其他资源匮乏地区的精神保健扩大工作中。在 ClinicalTrials.gov (NCT04385498) 注册，首次发布于 2020 年 5 月 13 日；https://www.clinicaltrials.gov/ct2/show/NCT04385498?term=ethiopia&cond=PTSD&draw=2&rank=1。