跳至主要内容
临床试验/NCT05890482
NCT05890482招募中不适用

Islamic Trauma Healing: A Scalable, Community-based Program for War and Refugee Trauma

University of Washington2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年5月15日最近更新:
适应症
干预措施

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)

Experimental

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)

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lori Zoellner

Professor: Psychology

University of Washington

研究点 (2)

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