Post Traumatic Stress DisorderNCT03761732
Islamic Trauma Healing: Feasibility Study
A study testing Islamic Trauma Healing in people with Post Traumatic Stress Disorder, run by University of Washington at 2 sites in Somalia.
Trial summary
This study will examine the initial feasibility of a program called Islamic Trauma Healing by conducting a small feasibility study (N = 26) of Islamic Trauma Healing in Somalia on key targets of PTSD, depression, somatic symptoms, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- 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
- 28 participants
- Where
- 2 sitesSomalia
- Study dates
- 15 Oct 2018to 6 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Experienced a DSM-5 trauma at least 12 weeks ago
- Report current re-experiencing or avoidance symptoms
- Islamic faith
- 18-65 year 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
Borama Mosque
Borama
Hargeisa Mosque
Hargeisa
About this study
This study will examine the initial feasibility of a program called Islamic Trauma Healing by conducting a small feasibility study (N = 26) of Islamic Trauma Healing in Somalia on key targets of PTSD, depression, somatic symptoms, and quality of life. The hypothesis is that those in Islamic Trauma Healing will show a reduction of PTSD symptoms, depressive symptoms, and somatic symptoms and show improvement in quality of well-being. Feasibility will also be examined by examining at retention, satisfaction, and community feedback.
Read the 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 low and moderate-income Muslim countries, examining the feasibility of implementing this lay-led program.
- Conditions
- Post Traumatic Stress Disorder
- 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
6 session behavioral intervention program designed to reduce PTSD and related symptomatology
| Study group | Role | What they receive |
|---|---|---|
| PTSD lay-led group treatment program | Experimental | The group will go through the Islamic Trauma Healing Program Receives: Behavioral: Islamic Trauma Healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016)
PTSD symptoms will be measured using the PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016). 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.
Measured: Last 1 Week
Secondary outcomes (3)
Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
The PHQ-9 is a self-report measure of depression symptoms with each question rated from 0-3. Higher scores indicate greater depression severity, with scores ranging from 0 to 27.
Measured: Last 1 Week
Somatic Symptoms Scale-8 (SSS-8; Gierk et al., 2014)
The Somatic Symptoms Scale is an 8 item version of the PHQ-15; self-report assessment of somatic symptoms (e.g., stomach pain, headaches, dizziness). The current version scored items on the original PHQ-15 scale from 0 to 2, with a range from 0 to 16.
Measured: Last 1 Week
Quality of Well-being Index
The WHO-5 Wellbeing Index (WHO-5; Bech, Olsen, Kjoller, \& Rasmussen, 2003) will be used to measure well-being. This five-item measure assesses emotional well-being on a 0-5 scale, with higher scores reflecting better well-being. Range of scores is from 0 to 25.
Measured: Last 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start15 Oct 2018
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is an active intervention feasibility study, using a pre-post clinical trial design; there is no randomization and no control intervention.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Seattle Pacific University
- Responsible party
- Principal investigator, Lori Zoellner, University of Washington
- Investigators
- Lori Zoellner, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761732
- Sponsor's protocol ID
- STUDY00005522
- Status last verified
- Feb 2023
- First submitted
- 14 Nov 2018
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klein AB, Egeh MH, Bowling AR, Holloway A, Ali AA, Abdillahi ZA, Abdi MA, Ibrahim SH, Bootan KH, Ibrahim HI, Ali AM, Tubeec AM, Dolezal ML, Angula DA, Bentley JA, Feeny NC, Zoellner LA. WhatsApp supervision for a lay-led Islamic trauma-focused intervention in Somaliland: Qualitative content analysis. J Trauma Stress. 2023 Feb;36(1):59-70. doi: 10.1002/jts.22882. Epub 2022 Oct 6.
PubMed 36204779Zoellner LA, Bentley JA, Feeny NC, Klein AB, Dolezal ML, Angula DA, Egeh MH. Reaching the Unreached: Bridging Islam and Science to Treat the Mental Wounds of War. Front Psychiatry. 2021 Jun 2;12:599293. doi: 10.3389/fpsyt.2021.599293. eCollection 2021.
PubMed 34149468
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Islamic Trauma Healing: Feasibility Study
- ClinicalTrials.gov ID
- NCT03761732
- Acronym / sponsor ID
- STUDY00005522
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Seattle Pacific University
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the initial feasibility of a program called Islamic Trauma Healing by conducting a small feasibility study (N = 26) of Islamic Trauma Healing in Somalia on key targets of PTSD, depression, somatic symptoms, and quality of life. The hypothesis is that those in Islamic Trauma Healing will show a reduction of PTSD symptoms, depressive symptoms, and somatic symptoms and show improvement in quality of well-being. Feasibility will also be examined by examining at retention, satisfaction, and community feedback.
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 low and moderate-income Muslim countries, examining the feasibility of implementing this lay-led program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an active intervention feasibility study, using a pre-post clinical trial design; there is no randomization and no control intervention.
| Arm | Type | Receives |
|---|---|---|
| PTSD lay-led group treatment program | Experimental | Behavioral: Islamic Trauma HealingThe group will go through the Islamic Trauma Healing Program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experienced a DSM-5 trauma at least 12 weeks ago
- Report current re-experiencing or avoidance symptoms
- Islamic faith
- 18-65 year 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 Healing6 session behavioral intervention program designed to reduce PTSD and related symptomatology | Behavioural | PTSD lay-led group treatment program |
Primary outcome
PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016)
Time frame: Last 1 Week
PTSD symptoms will be measured using the PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016). 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 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Time frame: Last 1 Week
Somatic Symptoms Scale-8 (SSS-8; Gierk et al., 2014)
Time frame: Last 1 Week
Quality of Well-being Index
Time frame: Last 1 Week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36204779Klein AB, Egeh MH, Bowling AR, Holloway A, Ali AA, Abdillahi ZA, Abdi MA, Ibrahim SH, Bootan KH, Ibrahim HI, Ali AM, Tubeec AM, Dolezal ML, Angula DA, Bentley JA, Feeny NC, Zoellner LA. WhatsApp supervision for a lay-led Islamic trauma-focused intervention in Somaliland: Qualitative content analysis. J Trauma Stress. 2023 Feb;36(1):59-70. doi: 10.1002/jts.22882. Epub 2022 Oct 6.
- Derived from this study: PubMed 34149468Zoellner LA, Bentley JA, Feeny NC, Klein AB, Dolezal ML, Angula DA, Egeh MH. Reaching the Unreached: Bridging Islam and Science to Treat the Mental Wounds of War. Front Psychiatry. 2021 Jun 2;12:599293. doi: 10.3389/fpsyt.2021.599293. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Lori 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 Post Traumatic Stress Disorder, 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: finished, as of the sponsor's last update on 21 Nov 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?
Yes. Results are posted in the registry (first posted 21 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016) (time frame: Last 1 Week). 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 NCT03761732, which also lists 2 linked publications.
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 21 Nov 2023.