RecruitingNot ApplicableNCT06295250

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

ASHA Bangladesh--An Integrated Intervention to Address Depression in Low Income Rural Women


Sponsor

University of Massachusetts, Worcester

Enrollment

680 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study (called ASHA Bangladesh) is testing an integrated program that combines financial assistance and mental health support (addressing both poverty and depression together) for economically vulnerable women in Bangladesh. The goal is to see whether tackling both problems at once is more effective than addressing them separately. **You may be eligible if...** - You are between 18 and 45 years old - You live in an economically vulnerable household (low income, food insecurity, or limited land ownership) - Your family is willing to participate - You score 10 or higher on the PHQ-9 depression scale at baseline - You have basic literacy (can read a simple sentence) **You may NOT be eligible if...** - You are currently pregnant - You have a cognitive or physical impairment that prevents participation - You plan to relocate or travel for more than 1 month during the 18-month study period - Your household has debt greater than 70,000 Taka Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALManualized Group Based Psychotherapy

Participants in the control group will receive a 10-session 6-month manualized group based psychotherapy treatment. The treatment is adapted from a WHO program called Problem Management Plus (PM+). PM+ includes 4 evidence based strategies: 1) problem solving; 2) increasing social support; 3) behavioral activation; and 4) relaxation through deep breathing. The intervention is delivered by trained non professional peers.

OTHERPoverty Alleviation

In addition to the psychotherapy intervention described above, participants in the experimental group will receive a poverty alleviation intervention adapted from the well-known Graduation Program--a poverty alleviation intervention widely used in low income countries. The poverty alleviation intervention includes a) 4 sessions of financial literacy education; b) savings accounts; c) consumption support equal to the cost of 1kg of rice per day for six months; d) productive asset transfer of 3 goats; e) 12 months of animal feed and veterinary care; f) gardening supplies; g) agricultural skill building.


Locations(1)

International Centre for Diarrhoeal Disease Research

Dhaka, Dhaka Division, Bangladesh

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NCT06295250


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