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

Recruiting now · Not applicable

Conditions studied: Depression, Economic Vulnerability, Anxiety, Culture Specific Symptoms

In brief

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.

Key facts

Study ID

NCT06295250

Run by

University of Massachusetts, Worcester

People needed

600

Starts

2024-03-01

Expected to finish

2026-12-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-45
• 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
• Family willingness to participate in the program
• Basic literacy as measured by ability to read a simple sentence;
• A score >=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale) at baseline

You may not qualify if…

• Pregnancy at screen;
• Cognitive or physical impairment precluding participation
• Plans to relocate or to travel for > 1 month during 18 M period.
• Household debt greater than 70,000 Taka

Where it is running

• International Centre for Diarrhoeal Disease Research — Dhaka, Dhaka Division, Bangladesh (enrolling)

Full record on ClinicalTrials.gov

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