PTSDITHNCT05890482
A Scalable, Community-based Program for War and Refugee Trauma
A study testing Islamic Trauma Healing in people with PTSD, run by University of Washington at 2 sites in Somalia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD
- What is being tested?
- Islamic Trauma Healing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSomalia
- Study dates
- 15 May 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Immediate suicide risk, with intent or plan
- Cannot understand consent/visible cognitive impairment
Trial locations and contacts
2 sites in 1 country.
Somalia2 sites, 2 recruiting
- Recruiting
Somaliland Youth Development and Voluntary Organization
Burao
Mohamed H Aideed, 252634439674, chairperson@soydavo.org
Abdisalan Awke, 252634439674, director@soydavo.org
- Recruiting
University of Burao
Burao
Essa N Liban, 252634940888, vc@uob-edu.net
About this study
Official title: Islamic Trauma Healing: A Scalable, Community-based Program for War and Refugee Trauma
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.
Read the detailed description
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.
- Conditions
- PTSD
- Being tested
- Islamic Trauma Healing
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Islamic Trauma HealingBehavioural
Manualized, lay-led psychosocial intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Islamic Trauma Healing |
| Wait List/Delayed (ITH) | Other | Six week waitlist condition and then crossed-over to six weeks of the ITH intervention Receives: Behavioral: Islamic Trauma Healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5
PTSD Severity, higher score worse severity, 0 to 80
Measured: Change from pre to week 6 (immediate post intervention)
Secondary outcomes (3)
Patient Health Questionnaire-9
Depression Severity, higher score worse severity, 0 to 27
Measured: Change from pre to week 6 (immediate post intervention)
Somatic Symptoms Scale-8
Somatic Symptom Severity, higher score worse severity, 0 to 32
Measured: 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
Measured: Change from pre to week 6 (immediate post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start15 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Principal investigator, Lori Zoellner, University of Washington
- Investigators
- Norah C Feeny, PhD, Principal investigator, Case Western Reserve UniversityJacob A Bentley, PhD, Principal investigator, University of WashingtonLori A Zoellner, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890482
- Sponsor's protocol ID
- STUDY00015447
- Other IDs
- R2HC #70165
- Acronym
- ITH
- Status last verified
- May 2023
- First submitted
- 20 Feb 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38222876
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Islamic Trauma Healing: A Scalable, Community-based Program for War and Refugee Trauma
- ClinicalTrials.gov ID
- NCT05890482
- Acronym / sponsor ID
- ITH / STUDY00015447
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- 15 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Islamic Trauma Healing (ITH) | Experimental | Behavioral: Islamic Trauma HealingA lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles. |
| Wait List/Delayed (ITH) | Other | Behavioral: Islamic Trauma HealingSix week waitlist condition and then crossed-over to six weeks of the ITH intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Immediate suicide risk, with intent or plan
- Cannot understand consent/visible cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Islamic Trauma HealingManualized, lay-led psychosocial intervention | Behavioural | Islamic Trauma Healing (ITH), Wait List/Delayed (ITH) |
Primary outcome
PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5
Time frame: Change from pre to week 6 (immediate post intervention)
PTSD Severity, higher score worse severity, 0 to 80
3 secondary outcomes
Patient Health Questionnaire-9
Time frame: Change from pre to week 6 (immediate post intervention)
Somatic Symptoms Scale-8
Time frame: Change from pre to week 6 (immediate post intervention)
World Health Organization-5 Wellbeing Index
Time frame: Change from pre to week 6 (immediate post intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Derived from this study: PubMed 38222876Zoellner 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norah C Feeny, PhD principal investigator
Case Western Reserve University
Jacob A Bentley, PhD principal investigator
University of Washington
Lori A Zoellner, PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Islamic Trauma Healing in people with PTSD, run by University of Washington at 2 sites in Somalia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Somalia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lori A Zoellner, PhD (2066853126, zoellner@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5 (time frame: Change from pre to week 6 (immediate post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05890482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.