Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT04532008
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2020-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Depression Treatment and Economic Empowerment
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '48 women randomized to either intervention or control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-28', 'studyFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive Symptoms', 'timeFrame': '12 months post baseline', 'description': 'symptoms on the Patient Health Questionnaire (PHD-9), ranging from 0 to 27, with higher scores indicating worse outcomes'}], 'secondaryOutcomes': [{'measure': 'Retention', 'timeFrame': 'Assessed at 12 Months post basline', 'description': 'Percentage of participants in the intervention group completing the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Symptoms']}, 'descriptionModule': {'briefSummary': 'This pilot study randomized 48 depressed rural Bangladeshi housewives to either intervention or control groups. The intervention groups received depression treatment and a financial empowerment intervention.', 'detailedDescription': 'This study was conducted in the rural Sirajganj region of Bangladesh. Working with the International Centre for Diarrhoeal Disease Research, Bangladesh and a local NGO, we recruited 48 depressed rural housewives for the study. Participants were randomized into intervention in control groups. The intervention groups (n=24) received 12 sessions of evidence based depression treatment, financial literacy education, agricultural training and skill building. They opened bank accounts and saved for six months. At the end of the six month period, participants who had met savings and attendance requirements received a cash transfer of approximately $186, which was used to purchase a productive asset. 22 participants purchased an agricultural animal, usually a goat; 1 financed a small retail business, and 1 leased land to grow crops for sale. Depression scores on the PHD-9 were sharply reduced. The study had 100% retention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-40\n* PHQ greater than 10\n* Able to save\n* Able to read and write\n\nExclusion Criteria:\n\n* Not in age range PhQ below 10 Unable to contribute to savings account Illiterate'}, 'identificationModule': {'nctId': 'NCT04532008', 'acronym': 'ASHA', 'briefTitle': 'Depression Treatment and Economic Empowerment', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'The ASHA Project: Pilot Study of a Depression Treatment/Economic Empowerment', 'orgStudyIdInfo': {'id': '2013-2320'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Experimental group received 12 session of group based depression treatment, a matched savings program, financial literacy training, agricultural training, and a cash transfer.', 'interventionNames': ['Behavioral: Group based treatment']}], 'interventions': [{'name': 'Group based treatment', 'type': 'BEHAVIORAL', 'description': '12 sessions of group based therapy that included cognitive restructuring, behavioral activation, and interpersonal therapy', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alison Karasz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Alison Karasz', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}