Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT06295250

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

Led by University of Massachusetts, Worcester ยท Updated on 2026-03-09

680

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

Sponsors

U

University of Massachusetts, Worcester

Lead Sponsor

I

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 45 years
  • Economic vulnerability as shown by household income of 15,000 Taka/month or less, food insufficiency in the past six months, or owning 10 decimals or less of land
  • Family willing to participate in the program
  • Basic literacy with ability to read a simple sentence
  • PHQ-9 depression score of 10 or higher at baseline
Not Eligible

You will not qualify if you...

  • Pregnant at screening
  • Cognitive or physical impairment that prevents participation
  • Plans to relocate or travel for more than 1 month during the 18-month study period
  • Household debt greater than 70,000 Taka

AI-Screening

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Trial Site Locations

Total: 1 location

1

International Centre for Diarrhoeal Disease Research

Dhaka, Dhaka Division, Bangladesh

Actively Recruiting

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Research Team

A

Alison Karasz, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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