Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-29 @ 12:56 AM
Study NCT ID:
NCT06809504
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Effectiveness of Structured Occupational Therapy (OT) Interventions on Patients With SUD in Inpatient Department (IPD) Settings, Focusing on Improvements in Cognitive, Physical, and Functional Domains
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '12 sessions over 4 weeks, 45-minute sessions divided into:\n\n* 15 minutes for physical exercises\n* 15 minutes for psychoeducation\n* 15 minutes for cognitive tasks and routine planning'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-01', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-02-01', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montreal Cognitive Assessment (MoCA):', 'timeFrame': 'baseline and after 12 weeks of intervention', 'description': 'The MoCA offers assessment of many cognitive aspects, it presents assessments for attention, memory, language, visual construction, executive functions, and orientation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Abuse Disorder']}, 'descriptionModule': {'briefSummary': 'OT emphasis lies within the scope of improving daily life activities, cognitive and physical performance in order to regain the proper social role. This work assesses the impact of a 12 session structured OT intervention program for patients with SUD in IPD. Benefitting from checklists like the Montreal Cognitive Assessment (MoCA), the Barthel Index, the Lawton-Brody IADLs scale, it substantiates attaining enhancements in expressive cognitive functions, ADLs, and IADLs to understand how selected OT intervention modalities can enhance functional capabilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Substance abused disorder\n* Admitted in rehabilitation center\n\nExclusion Criteria:\n\n* Severe cognitive impairment\n* Physical disability'}, 'identificationModule': {'nctId': 'NCT06809504', 'briefTitle': 'To Assess the Effectiveness of Structured Occupational Therapy (OT) Interventions on Patients With SUD in Inpatient Department (IPD) Settings, Focusing on Improvements in Cognitive, Physical, and Functional Domains', 'organization': {'class': 'OTHER', 'fullName': 'Foundation of Medical Research and Laboratories, Pakistan'}, 'officialTitle': 'Restoring Functionality: Occupational Therapy Interventions in Substance Use Drug Rehabilitation', 'orgStudyIdInfo': {'id': 'FMRL01'}, 'secondaryIdInfos': [{'id': 'FMRL01', 'type': 'OTHER', 'domain': 'Foundation of medical research and laboratory'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Exercise based intervention was given for 12 sessions over 4 weeks, 45-minute sessions', 'interventionNames': ['Behavioral: Exercise based intervention']}], 'interventions': [{'name': 'Exercise based intervention', 'type': 'BEHAVIORAL', 'description': '12 sessions over 4 weeks, 45-minute sessions divided into:\n\no 15 minutes for physical exercises', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'FMRL', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hammad Mursaleen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Mr', 'investigatorFullName': 'Hammad Mursaleen', 'investigatorAffiliation': 'Foundation of Medical Research and Laboratories, Pakistan'}}}}