Clinical trial NCT06295250: ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression
Official title: ASHA Bangladesh--An Integrated Intervention to Address Depression in Low Income Rural Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Economic Vulnerability
Keywords: Depression treatment
Cash Transfer
Problem Management Plus
Poverty Alleviation
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Georgetown University
name: National Institute of Mental Health (NIMH)
name: Albert Einstein College of Medicine
First posted: 2024-03-06
Enrollment: 660
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. married women;
2. age 18-75;
3. fluent in Bengali);
4. Meets criteria on an Economic Vulnerability Index
5. \>=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale at baseline

Exclusion Criteria:

1. Inability to provide informed consent;
2. Plans to travel for \> 1 month during 24 M period.
3. Inability to participate in the study for any other reason

Primary outcomes:
measure: Change in Depressive symptoms at 24 Months
timeFrame: 24 months
measure: Change in Depressive symptoms at intermediate timepoints
timeFrame: 6, 12, 18 months
measure: 24 Month Relapse
timeFrame: 24 months
Secondary outcomes:
measure: Economic vulnerability
timeFrame: Baseline, 12, and 24 Months
measure: Anxiety
timeFrame: Baseline, 6 Months, 12 Months, and 24 Months
measure: Function
timeFrame: Baseline, 6 Months, 12 Months, and 24 Months
measure: European Quality of Life Five Dimensions Five Level scale
timeFrame: Baseline, 6 Months, 12 Months, and 24 Months
measure: Tension Scale
timeFrame: Baseline, 6 Months, 12 Months, 18 months and 24 Months
Other outcomes:
measure: Implementation Outcomes--Adoption
timeFrame: Baseline + 30 days
measure: Implementation Outcomes--Feasibility
timeFrame: Six months
measure: Implementation outcomes--fidelity
timeFrame: Intervention months 1, 3 and 6
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research
Study officials:
affiliation: UMass Chan Medical School
name: Alison Karasz, PhD
role: PRINCIPAL_INVESTIGATOR
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