Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT02202694
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2014-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D003117', 'term': 'Color Vision Defects'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000077765', 'term': 'Cone Dystrophy'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083626', 'term': 'Psychosocial Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-13', 'studyFirstSubmitDate': '2014-04-15', 'studyFirstSubmitQcDate': '2014-07-28', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive and Negative syndrome scale (PANSS)', 'timeFrame': 'up to 6 months', 'description': 'The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.'}], 'secondaryOutcomes': [{'measure': 'Psychotic Symptom Rating Scales (PSYRATS)', 'timeFrame': 'Baseline ,3 months & 6 months', 'description': 'The PSYRATS consists of 17 items that focus on auditory hallucinations and delusions experienced over the past week.'}, {'measure': 'Insight rating scale', 'timeFrame': 'Baseline ,3 months & 6 months', 'description': 'Assesses Improvement in insight'}, {'measure': 'Calgary Depression Scale for Schizophrenia', 'timeFrame': 'Baseline ,3 months & 6 months', 'description': 'This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia.'}, {'measure': 'Short Explanatory Model Interview', 'timeFrame': 'Baseline ,3 months & 6 months', 'description': 'used to elicit beliefs of mental illness'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CBT, Psychosis, cultural adaptation, Pakistan'], 'conditions': ['Psychosis']}, 'referencesModule': {'references': [{'pmid': '29207980', 'type': 'DERIVED', 'citation': 'Husain MO, Chaudhry IB, Mehmood N, Rehman RU, Kazmi A, Hamirani M, Kiran T, Bukhsh A, Bassett P, Husain MI, Naeem F, Husain N. Pilot randomised controlled trial of culturally adapted cognitive behavior therapy for psychosis (CaCBTp) in Pakistan. BMC Health Serv Res. 2017 Dec 6;17(1):808. doi: 10.1186/s12913-017-2740-z.'}]}, 'descriptionModule': {'briefSummary': 'Aim:\n\nTo assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in Pakistan.\n\nDesign:\n\nRandomized Control Trial\n\nSetting:\n\nPsychiatry Departments of General Hospitals in Karachi.\n\nParticipants:\n\nA total of 36 patients with a diagnosis of psychotic disorder will be randomized to a psychological intervention or treatment as usual arm.\n\nIntervention:\n\nCulturally Adapted Cognitive Behavioral Therapy (CBT)\n\nOutcome measure:\n\nPositive and Negative syndrome scale (PANSS) Psychotic symptoms Rating Scales (PSYRATS)', 'detailedDescription': 'The purpose of the study is to test the feasibility of culturally adaptive CBT for Psychosis in Pakistan\n\nPrimary :\n\n-To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in Pakistan.\n\nSecondary:\n\n* To assess fidelity of culturally-adapted CBT for psychosis.\n* To further modify CaCBTp in accordance with findings of feasibility study\n\nThe Participants will be recruited from psychiatric department of different hospitals.They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirtysix participants will be recruited in the feasibility study and divided equally into two arms. This will ensure that, even after loss to follow-up, the investigators will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf. Randomization will be carried out by the on offsite statistician . This will provide a reliable geographically remote service. For intervention group twelve sessions of CaCBTp will be delivered by trained research clinician for a period of three months. Participants in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested Participants will be offered CaCBTp.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of Psychosis established by clinician using ICD10 criteria.\n2. Individuals aged between 18-65.\n3. Should not have learning disability.\n4. Resident of Karachi.\n5. Participant is able to give informed written consent\n\nExclusion Criteria:\n\n1. Severe illness which may affect capacity or markedly affect their ability to participate in interview, e.g. very thought disordered or distressed by symptoms.\n2. Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).'}, 'identificationModule': {'nctId': 'NCT02202694', 'briefTitle': 'Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan', 'organization': {'class': 'OTHER', 'fullName': 'Pakistan Institute of Living and Learning'}, 'officialTitle': 'Feasibility Study of Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan', 'orgStudyIdInfo': {'id': 'CBT-PSY-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Culturally Adapted Cognitive Behavior Therapy', 'interventionNames': ['Behavioral: Culturally Adapted Cognitive behavior therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients who will be randomized to the "treatment as usual" arm will receive routine care'}], 'interventions': [{'name': 'Culturally Adapted Cognitive behavior therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Psychosocial intervention'], 'description': 'This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Dow University of Health Sciences', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Nusrat Husain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pakistan Institute of Learning and Living, University of Manchester'}, {'name': 'Imran Chaudhry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manchester'}, {'name': 'Farooq Naeem, MRCPsych', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pakistan Institute of Learning and Living, University of Southampton'}, {'name': 'Raza ur Rehman, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dow University of Health Sciences'}, {'name': 'Ajmal Kazmi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pakistan Institute of Living and Learning'}, {'name': 'Munir Hamirani, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abbasi Shaheed Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pakistan Institute of Living and Learning', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Manchester', 'class': 'OTHER'}, {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, {'name': 'Abbasi Shaheed Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}