Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-27 @ 9:06 AM
Study NCT ID:
NCT06295250
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2024-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ASHA Bangladesh--An Integrated Intervention to Address Poverty and 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinding is difficult with behavioral studies. In this trial, efforts will be made to keep participants and interventionists from learning details of the trial design and alternate interventions. Outcome assessors will be blinded to randomization assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 660}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2024-02-27', 'studyFirstSubmitQcDate': '2024-02-27', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Implementation Outcomes--Adoption', 'timeFrame': 'Baseline + 30 days', 'description': 'The number of participants attending \\>-1 treatment session/# participants randomized. Based on recruitment and study records.'}, {'measure': 'Implementation Outcomes--Feasibility', 'timeFrame': 'Six months', 'description': 'Percent of participants attending \\>= 75 percent of intervention sessions--based on study records'}, {'measure': 'Implementation outcomes--fidelity', 'timeFrame': 'Intervention months 1, 3 and 6', 'description': 'Supervisor observations of sessions will be assessed for fidelity using a LIKERT scale that includes preparedness (0-3), Facilitation (0-11), Engagement (0-6) time management (0-1) and Documentation (0-1).'}], 'primaryOutcomes': [{'measure': 'Change in Depressive symptoms at 6 Months', 'timeFrame': '6 Months', 'description': 'Change in Symptoms from Baseline to 6 months post baseline, as measured by the Patient Health Questionnaire, a 9 item questionnaire designed to assess depressive symptoms. The minimum score is 0; the maximum score is 27.'}, {'measure': '24 Month Relapse', 'timeFrame': '24 months', 'description': 'Relapse is defined as a score of Patient Health Questionnaire\\>= 10 among participants who achieved remission at Time 2--6 months. To assess relapse, at each data collection point (6, 12, and 24 month) the investigators will ask participants about the experience of depressive symptoms at any time since the previous data collection point. Data collection will focus on 24 month relapse, or the presence of relapse at any time since Time 2.'}], 'secondaryOutcomes': [{'measure': 'Economic vulnerability index', 'timeFrame': 'Baseline, 12, and 24 Months', 'description': 'A composite index of economic vulnerability that includes income, assets, debt, food insecurity, financial worry. This measure does not have a fixed score but is composed using a pragmatic approach based on data collected in the field.'}, {'measure': 'Anxiety', 'timeFrame': 'Baseline, 6 Months, 12 Months, and 24 Months', 'description': 'Anxiety symptoms as measured on the General Anxiety Disorder scale--a seven item questionnaire with scores from 0-231. HIgher scores indicate more anxiety.'}, {'measure': 'Function', 'timeFrame': 'Baseline, 6 Months, 12 Months, and 24 Months', 'description': 'Function and disability as measured by the World Health Organization Disability Assessment Schedule, a 12 item questionnaire that is scored from 12-60 with higher scores indicating greater disability.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline, 6 Months, 12 Months, and 24 Months', 'description': 'Quality of life measure that includes five dimensions: mobility, self care, usual activities, pain/discomfort and anxiety/depression, scored from 0-100 with higher scores indicating better quality of life.'}, {'measure': 'Tension Scale', 'timeFrame': 'Baseline, 6 Months, 12 Months, 18 months and 24 Months', 'description': 'A questionnaire that measures both psychological symptoms as well as somatic cultural symptoms: a 39 item instrument measured from 0-3 with a minimum score of 0 and a maximum score of 117. with higher scores indicating higher levels of distress.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression treatment', 'Cash Transfer', 'Problem Management Plus', 'Poverty Alleviation'], 'conditions': ['Depression', 'Economic Vulnerability']}, 'referencesModule': {'references': [{'pmid': '14728109', 'type': 'BACKGROUND', 'citation': 'Greenberg PE, Kessler RC, Birnbaum HG, Leong SA, Lowe SW, Berglund PA, Corey-Lisle PK. 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The main question\\[s\\] it aims to answer are whether adding poverty alleviation to depression treatment in an integrated intervention: 1) improves depression outcomes at 6 months post baseline as measured by changes in the PHQ-9 from baseline; 2) reduces the chance of relapse (PHQ-9 \\>=10) at 24 months among patients who remitted (PHQ-9\\>=5) at six months; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in research interviews at 6,12 and 24 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. married women;\n2. age 18-75;\n3. fluent in Bengali);\n4. Meets criteria on an Economic Vulnerability Index\n5. \\>=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale at baseline\n\nExclusion Criteria:\n\n1. Inability to provide informed consent;\n2. Plans to travel for \\> 1 month during 24 M period.\n3. Inability to participate in the study for any other reason'}, 'identificationModule': {'nctId': 'NCT06295250', 'briefTitle': 'ASHA Bangladesh--An Integrated Intervention to Address Poverty and Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'ASHA Bangladesh--An Integrated Intervention to Address Depression in Low Income Rural Women', 'orgStudyIdInfo': {'id': 'STUDY00001114'}, 'secondaryIdInfos': [{'id': '7R01MH127577', 'link': 'https://reporter.nih.gov/quickSearch/7R01MH127577', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Depression Treatment (DT)', 'description': 'Participants in the control group will receive a 10 session 6 month manualized group based psychotherapy treatment..', 'interventionNames': ['Behavioral: Manualized Group Based Psychotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Integrated Intervention', 'description': 'The experimental arm includes 2 elements:\n\n1. The psychotherapy intervention described above.\n2. A poverty alleviation intervention', 'interventionNames': ['Behavioral: Manualized Group Based Psychotherapy', 'Other: Poverty Alleviation']}], 'interventions': [{'name': 'Manualized Group Based Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Manualized Group Based Psychotherapy. Adapted from the World Health Organization (WHO) Problem Management Plus (PM+) intervention, this intervention includes behavioral activation, enhancing social support, and problem management.', 'armGroupLabels': ['Depression Treatment (DT)', 'Integrated Intervention']}, {'name': 'Poverty Alleviation', 'type': 'OTHER', 'description': 'Modeled on the well-known Graduation Program, a poverty alleviation strategy widely used in low income countries, this intervention includes an asset transfer (agricultural animals), financial literacy education, a 6 month stipend, savings accounts, veterinary support, feed, and agricultural training', 'armGroupLabels': ['Integrated Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'state': 'Dhaka Division', 'status': 'RECRUITING', 'country': 'Bangladesh', 'contacts': [{'name': 'Fahmida Tofail, MBBS, PhD', 'role': 'CONTACT', 'email': 'ftofail@icddrb.org'}], 'facility': 'International Centre for Diarrhoeal Disease Research', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Alison Karasz, PhD', 'role': 'CONTACT', 'email': 'alison.karasz@umassmed.edu', 'phone': '3478435652'}], 'overallOfficials': [{'name': 'Alison Karasz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMass Chan Medical School'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'Data will be available indefinitely following the completion of analyses', 'ipdSharing': 'YES', 'description': 'We will create a deidentified dataset and it is our intention that these data be readily accessible and used. We will collaborate with and make our data available to other researchers for additional/secondary analyses. Formal data sharing agreements will be developed to guide and encourage further data mining of the proposed datasets for various purposes. All such data requests will be approved though by the investigative team, including the International Center for Diarrhoeal Disease Research (ICDDRB), to help ensure ethical use of the data.', 'accessCriteria': 'Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}, {'name': 'Georgetown University', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alison Karasz', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}