Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 7:19 AM
Study NCT ID:
NCT06302712
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Islamically Integrated Psychotherapy for Muslims With OCD in Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yale Brown Obsessive Compulsive Scale', 'timeFrame': '8 weeks', 'description': 'Yale Brown Obsessive Compulsive is a 10-item self-report scale developed to assess the severity of both obsession and compulsion.\n\nMinimum score is 0 and maximum score is 40. The higher the scores mean the worst outcome.\n\nCut-off Scores:\n\n0-7 (sub-clinical) 8-15 (Mild) 16-23 (Moderate) 24-31 (severe) 32-40 (Extrerme)'}], 'secondaryOutcomes': [{'measure': 'Depression, Stress, Anxiety', 'timeFrame': '8 Weeks.', 'description': 'Depression, Stress, Anxiety is measured through scale\n\nMinimum score is 0 and maximum score is 42. The higher the scores mean the worst outcome.\n\nCut-off scores for each subscales.\n\nStress:\n\n0-10 (normal) 11-18 (mild) 19-26 (moderate) 27-34 (severe) 35-42 (Extremely severe)\n\nAnxiety:\n\n0-6 (normal) 7-9 (mild) 10-14 (moderate) 15-19 (severe) 20-42 (Extremely severe)\n\nDepression:\n\n0-9 (normal) 10-12 (mild) 13-20 (moderate) 21-27 (severe) 28-42 (Extremely Severe)'}, {'measure': 'Thought Action Fusion', 'timeFrame': '8 weeks', 'description': 'Thought Action Fusion is measured with the help of Thought Action Fusion Scale\n\nMinimum score is 0 and maximum score is 76. The higher the scores mean the worst outcome.'}, {'measure': 'Thought Control', 'timeFrame': '8 weeks', 'description': 'Thought Control is measured with the help of Thought Control Questionnaire\n\nMinimum score is 30 and maximum score is 120. The higher the scores mean the worst outcome.'}, {'measure': 'Spiritual Quality', 'timeFrame': '8 weeks', 'description': 'Spiritual Quality is measured with the help of World Health Organization Quality of Life Spirituality, Religiousness and Personal Beliefs Scale\n\nMinimum score is 9 and maximum score is 45. The higher the scores mean the worst outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obsessive-Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'The current study aims to determine the effectiveness of the first culturally adapted Traditional Islamically Integrated Psychotherapy (TIIP) for Muslims with OCD in Pakistan along with the module effectiveness in reducing OCD symptoms with comorbidities like anxiety, depression, stress, thought control, thought-action fusion, and enhancing the spiritual quality of life of participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The client diagnosed with OCD according to DSM-5-TR.\n* The minimum score on Y-BOCS is 08 (i.e., indicating moderate level of symptoms)\n* The age range is from 18 to 40 years\n* The client has a minimum of eight years of formal education\n\nExclusion Criteria:\n\n* The client is having a comorbid diagnosis of severe psychiatric illness (e.g., psychotic disorders, personality disorder, substance use disorder, neurocognitive disorder)\n* The client is having a comorbidity of chronic physical illness\n* The client refused to sign the informed consent form,\n* The client has experience undergoing manualized faith-based CBT'}, 'identificationModule': {'nctId': 'NCT06302712', 'briefTitle': 'Traditional Islamically Integrated Psychotherapy for Muslims With OCD in Pakistan', 'organization': {'class': 'OTHER', 'fullName': 'International Islamic University Malaysia'}, 'officialTitle': 'Cultural Adaptation and Evaluation of Traditional Islamically Integrated Psychotherapy for Muslim With OCD in Pakistan: A Mixed-Method Study.', 'orgStudyIdInfo': {'id': 'TIIP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: Traditional Islamically Integrated Psychotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'TAU'}], 'interventions': [{'name': 'Traditional Islamically Integrated Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Traditional Islamically Integrated Psychotherapy for OCD. We will be using the culturally adapted module of TIIP that is translated into the Urdu language for Pakistan Muslims with OCD. The treatment module is mainly based on four domains Nafs (Behavior), Ihsas (Emotions), Aql (Thought), and Ruh (Spirituality). The session will be conducted in an individual format, with eight sessions, and the intervention will be conducted by a certified therapist in TIIP.', 'armGroupLabels': ['Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Islamic University Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation University Islamabad', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor.', 'investigatorFullName': 'Jamilah Hanum Abdul Khaiyom, PhD', 'investigatorAffiliation': 'International Islamic University Malaysia'}}}}