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| ID | Type | Description | Link |
|---|---|---|---|
| R2HC #70165 | Other Grant/Funding Number | Enhancing Learning & Research for Humanitarian Assistance |
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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Wait List/Delayed (ITH) | Other | Six week waitlist condition and then crossed-over to six weeks of the ITH intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Islamic Trauma Healing | Behavioral | Manualized, lay-led psychosocial intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5 | PTSD Severity, higher score worse severity, 0 to 80 | Change from pre to week 6 (immediate post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 | Depression Severity, higher score worse severity, 0 to 27 | Change from pre to week 6 (immediate post intervention) |
| Somatic Symptoms Scale-8 | Somatic Symptom Severity, higher score worse severity, 0 to 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Session Fidelity Checklist | Session by session rating of adherence to the protocol, higher better, 0% to 100%, average items completed | ITH Session 1 through Session 6 |
| Implementation Outcome Measure | Acceptability, appropriateness, and feasibility, higher better, 1 to 5 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lori A Zoellner, PhD | Contact | 2066853126 | zoellner@uw.edu | |
| Jacob A Bentley, PhD | Contact | 2067449534 | bentlj@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Norah C Feeny, PhD | Case Western Reserve University | Principal Investigator |
| Jacob A Bentley, PhD | University of Washington | Principal Investigator |
| Lori A Zoellner, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Somaliland Youth Development and Voluntary Organization | Recruiting | Burao | Somalia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38222876 | Derived | Zoellner LA, Feeny NC, Angula DA, Aideed MH, Liban EN, Egeh MH, Awke AI, Ismail AS, Kunle MA, Ali E, Levin CE, Burant CJ, Bentley JA. Islamic trauma healing (ITH): A scalable, community-based program for trauma: Cluster randomized control trial design and method. Contemp Clin Trials Commun. 2023 Dec 10;37:101237. doi: 10.1016/j.conctc.2023.101237. eCollection 2024 Feb. |
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Access to the data may be provided to qualified researchers engaging in independent scientific research on posttraumatic stress disorder. Data will be provided to the requesting party following review and approval of a research proposal, statistical analysis plan and execution of a Data Sharing Agreement. Data shared will be coded, with no personal health information included.
Data request can be submitted starting 9 months after the article publication and data will be accessible for up to 24 months. Extensions will be considered on a case by case basis.
Data will be provided to the requesting party following review and approval of a research proposal, statistical analysis plan, and execution of a Data Sharing Agreement.
For more information or to submit a request, please contact zoellner@uw.edu.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Main Study Consent English | Apr 22, 2022 | May 25, 2023 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Group Leader Consent English | Apr 22, 2022 | May 25, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Change from pre to week 6 (immediate post intervention) |
| World Health Organization-5 Wellbeing Index | Quality of Well-Being, higher score better well-being, 0 to 25 | Change from pre to week 6 (immediate post intervention) |
| Immediately post ITH intervention |
| Client Services Satisfaction Questionnaire | Satisfaction with ITH, high score higher satisfaction, 5 to 20 | Immediately post ITH intervention |
| University of Washington |
| Principal Investigator |
| University of Burao | Recruiting | Burao | Somalia |
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