Clinical trial NCT03502278: A Lay-Led Intervention for War and Refugee Related Trauma
Official title: A Lay-Led Intervention for War and Refugee Related Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: refugee
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Seattle Pacific University
name: Case Western Reserve University
First posted: 2018-04-18
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A small RCT (N = 60) will be conducted comparing Islamic Trauma Healing in an U.S. Somali refugee sample to a waitlist control
Primary purpose: TREATMENT

Brief summary: This study will examine the initial efficacy and feasibility of a program called Islamic Trauma Healing by conducting a small RCT (N = 60) comparing Islamic Trauma Healing in an U.S. Somali refugee sample to a waitlist control on key targets of PTSD, depression, somatic symptoms, and quality of life. The hypothesis is that those in Islamic Trauma Healing will show a greater reduction of PTSD symptoms, depressive symptoms, and somatic symptoms and show a greater improvement in quality of well-being than those in the waitlist condition (WL).

Detailed description: Islamic Trauma Healing is a lay-led, small-group intervention specifically targeting healing mental wounds of trauma within mosques. The six-session intervention combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles. A lay-led, group program promotes community building, acknowledges trauma's impact in the community, and facilitates wider implementation. The program is not referred to as "therapy" or "treatment" for "mental illness." It incorporates community building (e.g., shared tea, supplication), integrated Islamic principles that utilize cognitive restructuring through discussion of prophet narratives (e.g., faith during hard times, Prophet Job \[Ayyub\]), and exposure therapy through individual prayer, talking to Allah about the trauma. Ultimately, the program will follow a self-sustaining train-the-trainer model, led by group leaders, empowering lay leaders to facilitate healing in their communities. Further, training time is dramatically reduced to two, 4-hour training sessions, focusing on teaching skills of group discussion leading rather than training as a lay therapist or mental health counselor. Preliminary data from a community sample and from initial men's and women's groups show a strong perceived need and match with the Islamic faith, with large effects obtained for pre- to post-group across measures (g = 0.76-3.22). Qualitative analysis identified the intervention as operating on potential mechanisms of connectedness to the community, faith integration, healing, and growth. The preliminary data point to the program being well-received and offering a promising model for delivery of a trauma-focused intervention to Muslim communities. The next steps are examining Islamic Trauma Healing in a RCT, further isolating mechanisms of change, and ascertaining feasibility for wider dissemination studies.

Eligibility criteria: Inclusion Criteria:

* Experienced a DSM-5 trauma at least 12 weeks ago
* Report current re-experiencing or avoidance symptoms
* Somali background
* Islamic faith
* 18-65 year of age

Exclusion Criteria:

* Immediate suicide risk, with intent or plan
* Cannot understand consent/visible cognitive impairment

Primary outcomes:
measure: PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015
timeFrame: 3 Month Follow-up
Secondary outcomes:
measure: Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
timeFrame: 3 Month Follow-up
measure: Somatic symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15; Kroenke, Spitzer, & Williams, 2002)
timeFrame: 3 Month Follow-up
measure: Quality of well-being Index
timeFrame: 3 Month Follow-up
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Lori A Zoellner, PhD
role: PRINCIPAL_INVESTIGATOR
References: