Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT03761732
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2018-11-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Islamic Trauma Healing: Feasibility Study
Sponsor:
Organization:
Raw JSON
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The current version scored items on the original PHQ-15 scale from 0 to 2, with a range from 0 to 16.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Well-being Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PTSD Lay-led Group Treatment Program', 'description': 'The group will go through the Islamic Trauma Healing Program\n\nIslamic Trauma Healing: 6 session behavioral intervention program designed to reduce PTSD and related symptomatology'}], 'classes': [{'categories': [{'measurements': [{'value': '19.38', 'spread': '2.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last 1 Week', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PTSD Lay-led Group Treatment Program', 'description': 'The group will go through the Islamic Trauma Healing Program\n\nIslamic Trauma Healing: 6 session behavioral intervention program designed to reduce PTSD and related symptomatology'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PTSD Lay-led Group Treatment Program', 'description': 'The group will go through the Islamic Trauma Healing Program\n\nIslamic Trauma Healing: 6 session behavioral intervention program designed to reduce PTSD and related symptomatology'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Somalia', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PTSD Severity (PDS-5)', 'classes': [{'categories': [{'measurements': [{'value': '30.88', 'spread': '13.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Depression Symptoms (PHQ-9)', 'classes': [{'categories': [{'measurements': [{'value': '10.42', 'spread': '4.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Somatic Symptoms (SSS-8)', 'classes': [{'categories': [{'measurements': [{'value': '8.46', 'spread': '2.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Well-Being (WHO-5)', 'classes': [{'categories': [{'measurements': [{'value': '10.00', 'spread': '6.62', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-05', 'size': 267926, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-11-29T15:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is an active intervention feasibility study, using a pre-post clinical trial design; there is no randomization and no control intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-20', 'studyFirstSubmitDate': '2018-11-14', 'resultsFirstSubmitDate': '2021-07-16', 'studyFirstSubmitQcDate': '2018-11-30', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-20', 'studyFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016)', 'timeFrame': 'Last 1 Week', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)', 'timeFrame': 'Last 1 Week', 'description': '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.'}, {'measure': 'Somatic Symptoms Scale-8 (SSS-8; Gierk et al., 2014)', 'timeFrame': 'Last 1 Week', 'description': '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.'}, {'measure': 'Quality of Well-being Index', 'timeFrame': 'Last 1 Week', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '36204779', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34149468', 'type': 'DERIVED', 'citation': 'Zoellner 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experienced a DSM-5 trauma at least 12 weeks ago\n* Report current re-experiencing or avoidance symptoms\n* Islamic faith\n* 18-65 year of age\n\nExclusion Criteria:\n\n* Immediate suicide risk, with intent or plan\n* Cannot understand consent/visible cognitive impairment'}, 'identificationModule': {'nctId': 'NCT03761732', 'briefTitle': 'Islamic Trauma Healing: Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Islamic Trauma Healing: Feasibility Study', 'orgStudyIdInfo': {'id': 'STUDY00005522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PTSD lay-led group treatment program', 'description': 'The group will go through the Islamic Trauma Healing Program', 'interventionNames': ['Behavioral: Islamic Trauma Healing']}], 'interventions': [{'name': 'Islamic Trauma Healing', 'type': 'BEHAVIORAL', 'description': '6 session behavioral intervention program designed to reduce PTSD and related symptomatology', 'armGroupLabels': ['PTSD lay-led group treatment program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Borama', 'country': 'Somalia', 'facility': 'Borama Mosque', 'geoPoint': {'lat': 9.93611, 'lon': 43.18278}}, {'city': 'Hargeisa', 'country': 'Somalia', 'facility': 'Hargeisa Mosque', 'geoPoint': {'lat': 9.56, 'lon': 44.065}}], 'overallOfficials': [{'name': 'Lori Zoellner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Case Western Reserve University', 'class': 'OTHER'}, {'name': 'Seattle Pacific University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lori Zoellner', 'investigatorAffiliation': 'University of Washington'}}}}