NCT03502278

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 14, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

4 years

First QC Date

March 13, 2018

Last Update Submit

February 20, 2023

Conditions

PTSD

Keywords

refugee

Outcome Measures

Primary Outcomes (1)

  • PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015

    PTSD symptoms will be measured using the PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015). Twenty items comprise the PTSD severity scale, with scores ranging from 0 to 80 and higher scores indicating higher PTSD severity. A total score is calculated.

    3 Month Follow-up

Secondary Outcomes (3)

  • Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)

    3 Month Follow-up

  • Somatic symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15; Kroenke, Spitzer, & Williams, 2002)

    3 Month Follow-up

  • Quality of well-being Index

    3 Month Follow-up

Study Arms (2)

PTSD lay-led group treatment program

ACTIVE COMPARATOR

This group will go through the Islamic Trauma Healing Program

Behavioral: Islamic Trauma Healing

Waitlist

NO INTERVENTION

Waitlist

Interventions

Islamic Trauma HealingBEHAVIORAL

A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles

PTSD lay-led group treatment program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Case Western Reserve University

Cleveland, Ohio, 44106-7123, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Zoellner LA, Bentley JA, Musa K, Mohamed F, Ahmed LB, King KM, Feeny NC; Islamic Trauma Healing Clinical Team. Lay-Led Intervention for War and Refugee Trauma: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2429661. doi: 10.1001/jamanetworkopen.2024.29661.

    PMID: 39186273DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Lori A Zoellner, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A small RCT (N = 60) will be conducted comparing Islamic Trauma Healing in an U.S. Somali refugee sample to a waitlist control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2018

First Posted

April 18, 2018

Study Start

July 14, 2018

Primary Completion

July 14, 2022

Study Completion

July 14, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Data will be shared with the NIMH Data Archive

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Per requirements of the NIMH Archive.
Access Criteria
Per requirements of the NIMH Archive.

Locations

US(2)