protocolSection identificationModule nctId: NCT06295250, orgStudyIdInfo id: STUDY00001114, secondaryIdInfos id: 7R01MH127577, type: NIH, link: https://reporter.nih.gov/quickSearch/7R01MH127577, briefTitle: ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: International Centre for Diarrhoeal Disease Research, Bangladesh, collaborators name: Georgetown University, collaborators name: National Institute of Mental Health (NIMH), collaborators name: Albert Einstein College of Medicine, descriptionModule briefSummary: The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question\[s\] it aims to answer are: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months., conditionsModule conditions: Depression, conditions: Economic Vulnerability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Interventionists and outcome assessors will not be informed regarding the study design and research question., whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 660, type: ESTIMATED, armsInterventionsModule interventions name: Manualized Group Based Psychotherapy, interventions name: Poverty Alleviation, outcomesModule primaryOutcomes measure: Change in Depressive symptoms at 24 Months, primaryOutcomes measure: Change in Depressive symptoms at intermediate timepoints, primaryOutcomes measure: 24 Month Relapse, secondaryOutcomes measure: Economic vulnerability, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Function, secondaryOutcomes measure: European Quality of Life Five Dimensions Five Level scale, secondaryOutcomes measure: Tension Scale, otherOutcomes measure: Implementation Outcomes--Adoption, otherOutcomes measure: Implementation Outcomes--Feasibility, otherOutcomes measure: Implementation outcomes--fidelity, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: International Centre for Diarrhoeal Disease Research, city: Dhaka, country: Bangladesh, contacts name: Fahmida Tofail, MBBS, PhD, role: CONTACT, email: ftofail@icddrb.org, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False