Treating depressive symptomatology in Congolese Refugees in Uganda and Rwanda: Adapting and Evaluating Community-based Sociotherapy

难民出现精神健康问题的比率较高，包括抑郁症和创伤后应激障碍*1,2,3。难民每天面临各种各样的压力因素（例如无法获得基本资源、缺乏安全和保障、家庭暴力的风险），这些都影响到心理健康*4。在紧急情况下提供社会心理支持的指南*5已经存在，但关于哪种方法最有效，以及这些干预措施是否能够以足够的规模提供*6的争论仍然存在。高技能专业人员的缺乏意味着需要外行人员“分担任务”*7。以社区为基础的方法为治疗常见精神障碍提供了希望，为社会所接受，并可减轻初级卫生保健的压力*8,9。刚果民主共和国的冲突导致大量刚果难民逃往卢旺达和乌干达。自2005年以来，为促进1994年种族灭绝*10后的社区联系和个人福祉，已向卢旺达2万多人提供了基于社区的社会治疗。CBS由外行辅导员提供，每周15次，每次3小时。世界卫生组织将CBS描述为一种利用“个人与其社会环境之间的相互作用来促进价值观、规范和关系的重建……同时提供辩论、分享经验和应对机制的机会*11。与常规护理相比，在8个月的随访中，哥伦比亚广播公司显著提高了卢旺达受冲突影响民众的公民参与度，显著减少了他们的痛苦*12。难民专员办事处注意到哥伦比亚广播公司对难民的潜力*13，但尚未对这些人口进行评估。该项目将使用多种学科：1)调整CBS和评估措施，用于卢旺达和乌干达的刚果难民；2)调查适应CBS （aCBS）减轻刚果难民抑郁症状的疗效和成本效益，并确定社会资本和日常压力源水平的变化是否与抑郁症状的变化有关；3)与联合国难民事务高级专员办事处（UNHCR）共同制定实施指南，以便在不同环境中为难民调整和传播aCBS。在第一阶段，将采用设计、实施、监测和评估（DIME）方法*14（利用关键信息提供者访谈和焦点小组）来调整评估措施和aCBS内容。然后，一项两组随机对照试验（试点阶段）将aCBS与常规强化护理（即对非政府组织工作人员进行心理健康指南培训和审查转诊途径）进行比较。成年刚果难民（除了那些有复杂心理健康问题、积极的自杀意念和/或智力残疾的人）将有资格参加。这将避免参与者因使用心理健康标签而被污名化的风险。分析将考虑抑郁症状的水平（PHQ-9*15），以及他们是否在基线时符合迷你内部神经精神病学访谈抑郁模块（MINI*16）的抑郁标准。总共将招募720名参与者；每个研究组360人。评估结果将包括痛苦水平（SRQ-2018*17）、功能（WHOQoL-BREF*18）、社会资本（SASCAT*19）、幸福感（WHO-5*20）、日常压力源（CDES*21）和创伤事件清单*21。参与者将在基线、基线后16周和32周进行评估。TSC/DMC将监督试验。将评估aCBS的成本效益。将进行基于正常化过程理论（www.normalizationprocess.org）的“过程评估”*22，以探索促进和阻碍与aCBS接触的因素。项目网页、推特帐户、简报、知识交流活动、会议演讲和学术论文将传播项目结果并影响决策者。

Refugees experience elevated rates of mental health difficulties including depression and post-traumatic stress disorder*1,2,3. Refugees face a wide-range of daily stressors (e.g. lack of access to basic resources, lack of safety and security, risk of family violence) that impact on mental health*4. Guidelines exist for delivering psychosocial support in emergency situations*5, but contention remains about which approaches are most effective, and whether these interventions can be delivered at sufficient scale*6. An absence of highly-skilled professionals means that the 'task-sharing' of roles to lay people is required*7. Community-based approaches offer promise for treating common mental disorders, are socially acceptable, and can decrease pressure on primary healthcare*8,9.Conflict in the Democratic Republic of Congo has led to large numbers of Congolese refugees in Rwanda and Uganda. Community-based Sociotherapy (CBS) has been delivered to over 20,000 people in Rwanda since 2005 to promote community connections and individual wellbeing after the genocide of 1994*10. CBS is delivered by lay-facilitators over fifteen weekly 3-hour group sessions. The WHO described CBS as an approach that uses 'the interactions between individuals and their social environment to facilitate the re-establishment of values, norms, and relationships...and at the same time provide the opportunity for debate, the sharing of experiences and coping mechanisms'*11, Compared with usual care, CBS resulted in significantly increased civic participation and significantly decreased distress in conflict-affected people in Rwanda at 8 months follow-up*12. The UNHCR has noted the potential of CBS for refugees*13, but it has not yet been evaluated in these populations.The project will use a mix of disciplines to: 1) adapt CBS and assessment measures for use with Congolese refugees in Rwanda and Uganda; 2) investigate the efficacy and cost-effectiveness of adapted CBS (aCBS) for reducing depressive symptoms in Congolese refugees, and determine whether changes in levels of social capital and daily stressors are integral to changes in depressive symptoms; 3) develop implementation guidance for adapting and disseminating aCBS for refugees across diverse settings in conjunction with the UNHCR.In the first phase, the Design, Implementation, Monitoring and Evaluation (DIME) approach*14 (which utilises key informant interviews and focus groups) will be used to adapt assessment measures and aCBS content. Then a 2-arm cluster randomised controlled trial (with pilot phase) will compare aCBS to an enhanced care as usual (i.e. training for NGO workers in mental health guidelines and reviewing referral pahways). Adult Congolese refugees (apart from those with complex mental health difficulties, active suicidal ideation and/or intellectual disabilities) will be eligible to participate. This will avoid the risk of participants being stigmatised by the use of mental health labels. Analyses will take account of levels of depressive symptoms (PHQ-9*15), and whether they meet criteria for a depression on the Mini-Internal Neuropsychiatric Interview Depression Module (MINI*16) at baseline. A total of 720 participants will be recruited; 360 per study arm. Assessed outcomes will include levels of distress (SRQ-2018*17), functioning (WHOQoL-BREF*18), social capital (SASCAT*19), wellbeing (WHO-5*20), daily stressors (CDES*21), and Trauma Events Inventory*21. Participants will be assessed at baseline, 16- and 32-weeks post-baseline. A TSC/DMC will monitor the trial. The cost-effectiveness of aCBS will be evaluated. A 'process evaluation'*22 based on Normalisation Process Theory (www.normalizationprocess.org) will be undertaken to explore factors that facilitate and impede engagement with aCBS. A project webpage, Twitter account, briefings, knowledge exchange events, conference presentations and academic papers will disseminate project findings and influence decision makers.