Posttraumatic stress disorder intervention for people with severe mental illness in a low-income country primary care setting: a randomized feasibility trial protocol.
Posttraumatic stress disorder intervention for people with severe mental illness in a low-income country primary care setting: a randomized feasibility trial protocol.
复制标题
DOI：
10.1186/s40814-021-00883-3
复制
发表时间：
2021-07-30
影响因子：
1.7
通讯作者：
Hanlon C
中科院分区：
文献类型：
--
作者：
Ng LC;Serba EG;Dubale BW;Fekadu A;Hanlon C
在本协议中，我们概述了埃塞俄比亚短暂放松、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创伤后应激障碍（PTSD）的文化和环境适应性干预措施。呼吸埃塞俄比亚遵循世界卫生组织关于低收入和中等收入国家初级保健机构创伤后应激障碍 (PTSD) 治疗的指南。具体来说，本研究包括一项非随机预试点 (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、干预措施的可接受性和可行性，并调查潜在的有效性和实施情况。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，包括符合资格、同意、参与治疗和完成评估的参与者数量，以及评估和干预的可行性和可接受性。还将收集有关干预实施的促进者和障碍的定性数据以及有关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，包括关于PTSD、耻辱感、创伤相关认知和生理唤醒的知识。这项研究的结果将为未来的全面随机对照试验提供信息，如果发现有效，该干预措施有可能被纳入其他资源匮乏地区的精神卫生保健扩大工作中。在 ClinicalTrials.gov 注册 (NCT04385498) 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。在线版本包含可在 10.1186/s40814-021-00883-3 获取的补充材料。
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. The online version contains supplementary material available at 10.1186/s40814-021-00883-3.