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Recruiting NCT06295250

ASHA Bangladesh--An Integrated Intervention to Address Poverty and Depression

Trial Parameters

Condition Depression
Sponsor University of Massachusetts, Worcester
Study Type INTERVENTIONAL
Phase N/A
Enrollment 680
Sex FEMALE
Min Age 18 Years
Max Age 45 Years
Start Date 2024-03-01
Completion 2026-12
Interventions
Manualized Group Based PsychotherapyPoverty Alleviation

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 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--compared to depression treatment alone; 2) reduces the chance of relapse (PHQ-9 \>=5) at 18 months among patients who remitted (PHQ-9\<5) at six months--compared to depression treatment alone; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention--compared to depression treatment alone. Other outcomes that will be studied include economic vulnerability and psychosocial variables such as anxiety, culturally specific symptoms, quality of life, and function. Participants in both arms will participate in research interviews at 6,12 and 18 months. The project also includes a mixed methods implementation evaluation. Quantitative implementation outcomes to be examined include adoption/uptake; retention in the intervention, and fidelity of intervention delivery. A qualitative process evaluation will include interviews with 80 study participants and approximately 40 staff members, including research staff, agricultural officers, and interventionist staff.

Eligibility Criteria

Inclusion Criteria: 1. Age 18-45 2. Meets criteria for Economic Vulnerability as measured by: household income \<= 15000 Taka per month; food insufficiency in household over previous six months; OR owning \<= 10 decimals of land 3. Family willingness to participate in the program 4. Basic literacy as measured by ability to read a simple sentence; 5. A score \>=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale) at baseline Exclusion Criteria: 1. Pregnancy at screen; 2. Cognitive or physical impairment precluding participation 3. Plans to relocate or to travel for \> 1 month during 18 M period. 4. Household debt greater than 70,000 Taka

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