Islamic Trauma Healing: A Scalable, Community-based Program for War and Refugee Trauma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5
研究概览
简要总结
In low and middle-income countries, access to state-of-the-art mental health care is often limited. Islamic Trauma Healing (ITH) is a manualized mosque-based, lay-led group intervention aimed at healing the individual and communal mental wounds of war and refugee trauma. The investigators will execute a hybrid effectiveness-implementation randomized controlled trial (RCT) of ITH versus delayed ITH to evaluate mental health effectiveness and ease of implementation.
详细描述
Background: Somalia has long been in a state of humanitarian crisis; trauma-related mental health needs are extremely high. Access to state-of-the-art mental health care is limited. Islamic Trauma Healing (ITH) is a manualized mosque-based, lay-led group intervention aimed at healing the individual and communal mental wounds of war and refugee trauma. The 6-session intervention combines Islamic principles with empirically-supported exposure and cognitive restructuring principles for posttraumatic stress disorder (PTSD). ITH reduces training time, uses a train the trainers (TTT) model, and relies on local partnerships embedded within the strong communal mosque infrastructure.
Methods: The investigators will conduct a hybrid effectiveness-implementation randomized control trial (RCT) in the Somaliland, with implementation in the cities of Hargeisa, Borama, and Burao. In this study, a lay-led, mosque-based intervention, Islamic Trauma Healing (ITH), to promote mental health and reconciliation will be examined in 200 participants, randomizing mosques to either immediate ITH or a delayed (waitlist; WL) ITH conditions. Participants will be assessed by assessors masked to condition at pre, 3 weeks, 6 weeks, and 3 month follow-up. Primary outcome will be assessor-rated posttraumatic stress symptoms (PTSD), with secondary outcomes of depression, somatic symptoms, and well-being. A TTT model will be tested, examining the implementation outcomes. Additional measures include potential mechanisms of change and economic evaluation.
Conclusion: This trial has the potential to provide effectiveness and implementation data for an empirically-based principle trauma healing program for the larger Islamic community that may not seek mental health care or does not have access to such care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experienced a DSM-5 Criterion A trauma at least 12 weeks ago
- •Report current re-experiencing or avoidance PTSD symptoms
- •Islamic faith
- •18-70 years of age
排除标准
- •Immediate suicide risk, with intent or plan
- •Cannot understand consent/visible cognitive impairment
研究组 & 干预措施
Islamic Trauma Healing (ITH)
A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles.
干预措施: Islamic Trauma Healing (Behavioral)
Wait List/Delayed (ITH)
Six week waitlist condition and then crossed-over to six weeks of the ITH intervention
干预措施: Islamic Trauma Healing (Behavioral)
结局指标
主要结局
PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5
时间窗: Change from pre to week 6 (immediate post intervention)
PTSD Severity, higher score worse severity, 0 to 80
次要结局
- World Health Organization-5 Wellbeing Index(Change from pre to week 6 (immediate post intervention))
- Somatic Symptoms Scale-8(Change from pre to week 6 (immediate post intervention))
- Patient Health Questionnaire-9(Change from pre to week 6 (immediate post intervention))
研究者
Lori Zoellner
Professor: Psychology
University of Washington
