BACKGROUND A large proportion of Syrians have been exposed to potentially traumatic events, multiple losses, and breakdown of supportive social networks and many of them have sought refuge in host countries where they also face post-migration living difficulties such as discrimination or integration problems or both. These adversities may put Syrian refugees at high risk for common mental disorders. In response to this, the World Health Organization (WHO) developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM+) to reduce psychological distress among populations exposed to adversities. PM+ has been adapted for Syrian refugees and can be delivered by non-specialist peer lay persons in the community. METHODS A randomized controlled trial (RCT) will be conducted with 380 Syrian refugees in Turkey. After providing informed consent, participants with high levels of psychological distress (scoring above 15 on the Kessler-10 Psychological Distress Scale (K10)) and functional impairment (scoring above 16 on the WHO Disability Assessment Schedule 2.0, or WHODAS 2.0) will be randomly assigned to Group PM+/enhanced care as usual (Group PM+/E-CAU) (n = 190) or E-CAU (n = 190). Outcome assessments will take place 1 week after the fifth session (post-assessment), 3 months after the fifth session and 12 months after baseline assessment. The primary outcome is psychological distress as measured by the Hopkins Symptom Checklist (HSCL-25). Secondary outcomes include functional impairment, post-traumatic stress symptoms, self-identified problems, and health system and productivity costs. A process evaluation will be conducted to explore the feasibility, challenges and success of the intervention with 25 participants, including participants, facilitators, policy makers and mental health professionals. DISCUSSION The treatment manual of the Syrian-Arabic Group PM+ and training materials will be made available through the WHO once the effectiveness and cost-effectiveness of Group PM+ have been established. TRIAL REGISTRATION Clinical Trial Registration: ClinicalTrials.gov Identifier NCT03960892. Unique protocol ID: 10/2017. Prospectively registered on 21 May 2019.

中文翻译：

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随机对照试验的协议：针对土耳其成年叙利亚难民的点对点小组问题管理增强版（PM +）。

背景技术很大一部分叙利亚人遭受了潜在的创伤事件，多重损失和支持性社会网络的崩溃，其中许多人在东道国寻求庇护，在那里他们还面临着移民后的生活困难，例如歧视或融合问题，或两者兼而有之。这些逆境可能使叙利亚难民极有可能患上常见的精神疾病。为此，世界卫生组织（WHO）开发了一种跨诊断的，可扩展的心理干预措施，称为“问题管理增强”（PM +），以减少遭受逆境的人群的心理困扰。PM +已针对叙利亚难民进行了调整，可以由社区中的非专业人员同业者交付。方法将对380名在土耳其的叙利亚难民进行随机对照试验（RCT）。在征得知情同意后，患有高水平心理困扰（在Kessler-10心理困扰量表（K10）上得分超过15）和功能障碍（在WHO残疾评估表2.0或WHODAS 2.0上得分超过16）的参与者将被随机分配。照常分配给PM + /增强护理（PM + / E-CAU组）（n = 190）或E-CAU（n = 190）。结果评估将在第五届会议后（评估后）一周，第五届会议后三个月和基线评估后十二个月进行。霍普金斯症状清单（HSCL-25）衡量的主要结果是心理困扰。次要结果包括功能障碍，创伤后压力症状，自我发现的问题以及卫生系统和生产力成本。将进行过程评估以探讨可行性，25名参与者（包括参与者，主持人，政策制定者和精神卫生专业人员）的干预措施面临的挑战和成功。讨论一旦建立了PM +组的有效性和成本效益，将可以通过WHO获得叙利亚-阿拉伯PM +组的治疗手册和培训材料。试验注册临床试验注册：ClinicalTrials.gov标识符NCT03960892。唯一的协议ID：10/2017。预计于2019年5月21日注册。讨论一旦建立了PM +组的有效性和成本效益，将通过世界卫生组织提供叙利亚-阿拉伯PM +组的治疗手册和培训材料。试验注册临床试验注册：ClinicalTrials.gov标识符NCT03960892。唯一的协议ID：10/2017。预计于2019年5月21日注册。讨论一旦建立了PM +组的有效性和成本效益，将通过世界卫生组织提供叙利亚-阿拉伯PM +组的治疗手册和培训材料。试验注册临床试验注册：ClinicalTrials.gov标识符NCT03960892。唯一的协议ID：10/2017。预计于2019年5月21日注册。