Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT01725932
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2012-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Cognitive Therapy Based Self Help Manual for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-16', 'studyFirstSubmitDate': '2012-10-31', 'studyFirstSubmitQcDate': '2012-11-08', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Anxiety and depression Rating Scale- Depression subscale', 'timeFrame': 'Participants will be assessed at baseline and then end of therapy at 12 weeks', 'description': 'Measurement of depression'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale, Anxiety subscale', 'timeFrame': 'Participants will be assessed at baseline and then end of therapy at 12 weeks', 'description': 'Measurement of anxiety'}, {'measure': 'Bradford Somatic Inventory', 'timeFrame': 'Participants will be assessed at baseline and then end of therapy at 12 weeks', 'description': 'Measurement of somatic symptoms'}, {'measure': 'Brief disability questionnaire', 'timeFrame': 'Participants will be assessed at baseline and then end of therapy at 12 weeks', 'description': 'To measure disability associated with depression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['culture, depression, cognitive therapy, behaviour therapy,'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'While CBT (Cognitive Behaviour Therapy)has been found to be effective in treating depression in West, only limited amount of research has been conducted to find assess its effectiveness in low and middle income countries. We have developed culturally sensitive CBT during the last few years in Pakistan. Pakistan has high rates of depression. And there is currently a need to develop and test evidence based treatments which are culturally sensitive and cost effective. IN this project we will be assessing the effectiveness of a culturally sensitive CBT based self help intervention for depression in Pakistan against care as usual, using a randomized controlled design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All those who fulfil the diagnosis of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (International Classification of Diseases, Research Diagnostic Criteria), scored 8 or more on HADS (Hospital Anxiety and Depression Scale) Depression Sub-scale, are between the ages of 18-60 and either patient or the carer has at least 5 years of education.\n\nExclusion Criteria:\n\n* The exclusion criteria include; excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence) significant cognitive impairment (for example learning disability or dementia) and active psychosis.'}, 'identificationModule': {'nctId': 'NCT01725932', 'acronym': 'CaCBT_SH', 'briefTitle': 'Randomized Controlled Trial of Cognitive Therapy Based Self Help Manual for Depression', 'organization': {'class': 'OTHER', 'fullName': 'Pakistan Association of Cognitive Therapists'}, 'officialTitle': 'A Multicentre Randomised Controlled Trial of Culturally Adapted CBT Based Self Help Manual for Depression in Pakistan', 'orgStudyIdInfo': {'id': 'PACT_SHCBTD_2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Culturally adapted CBT based Self Help', 'description': 'Culturally sensitive cbt based self help intervention, which consists of 6 regular chapters and 2 additional chapters. The self help intervention involves family to improve compliance with the intervention', 'interventionNames': ['Behavioral: Culturally adapted CBT based Self Help']}, {'type': 'NO_INTERVENTION', 'label': 'Care As Usual', 'description': 'Control Group'}], 'interventions': [{'name': 'Culturally adapted CBT based Self Help', 'type': 'BEHAVIORAL', 'description': "Intervention was based on our initial work using mixed methods, using mixed methods,in Pakistan. It focused on psycho-education, symptoms management, changing negative thinking, behavioral activation, problem solving, improving relationships and communication skills. One person from the family was involved in all cases. The intervention consists of 7 chapters. Manual can be used by the patient's or carers with at least 5 years of education. A member of the research team called them once every week to remind them of the next chapter and also to discuss any issues o problems that emerged during the previous week. This manual can be downloaded from PACT website (http://www.pactorganization.com/)", 'armGroupLabels': ['Culturally adapted CBT based Self Help']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mehwish Khalid, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'PACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pakistan Association of Cognitive Therapists', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}