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NCT Number: NCT06295250

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

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Culture Specific Symptoms Economic Vulnerability Mental Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

International Centre for Diarrhoeal Disease Research

Dhaka, Dhaka Division, Bangladesh

Location status: Recruiting

Location contact

Fahmida Tofail, MBBS, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Manualized Group Based Psychotherapy

Behavioral

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.

Poverty Alleviation

Other

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.

Primary outcomes

  1. Change in Depressive symptoms at 6 Months

    Time frame: 6 Months

    Change in Symptoms from Baseline to 6 months post baseline, as measured by the Patient Health Questionnaire, a 9 item questionnaire designed to assess depressive symptoms. The minimum score is 0; the maximum score is 27.

Secondary outcomes

  1. 18-Month Relapse

    Time frame: 18 months

    Relapse is defined as a score of Patient Health Questionnaire>= 5 among participants who achieved remission at Time 2: 6 months. To assess relapse, at each data collection point (6, 12, and 18 month) the investigators will ask participants about the experience of depressive symptoms at any time since the previous data collection point. Data collection will focus on 18 month relapse, or the presence of relapse at any time since Time 2.

  2. Depression at 12 and 18 months

    Time frame: 12 and 18 months

    Changes between PHQ-9 and Baseline at other time points: 12 and 18 months

  3. Economic vulnerability Index

    Time frame: Baseline, 12, and 18 Months

    A composite index of economic vulnerability including a variety of indicators such as income, debt, and food insecurity.

  4. Anxiety

    Time frame: Baseline, 6 Months, 12 Months, and 18 Months

    Anxiety symptoms as measured on the General Anxiety Disorder scale - a seven item questionnaire with scores from 0-21. Higher scores indicate more anxiety.

  5. Function

    Time frame: Baseline, 6 Months, 12 Months, and 18 Months

    Function and disability as measured by the World Health Organization Disability Assessment Schedule, a 12 item questionnaire that is scored from 12-60 with higher scores indicating greater disability.

  6. Change in Quality of Life

    Time frame: Baseline, 6 Months, 12 Months, and 18 Months

    Quality of life measure that includes five dimensions: mobility, self care, usual activities, pain/discomfort and anxiety/depression, scored from 0-100 with higher scores indicating better quality of life.

  7. Tension Scale

    Time frame: Baseline, 6 Months, 12 Months, 18 months

    A questionnaire that measures both psychological symptoms as well as somatic cultural symptoms: a 39 item instrument measured from 0-3 with a minimum score of 0 and a maximum score of 117 with higher scores indicating higher levels of distress.

Other outcomes

  1. Implementation Outcomes--Adoption

    Time frame: Baseline + 30 days

    The number of participants attending >=1 treatment session/number of participants randomized. Based on recruitment and study records.

  2. Implementation Outcomes--Feasibility

    Time frame: 6 months

    Percent of participants attending >= 70 percent of intervention sessions (7 sessions) - based on study records.

  3. Implementation outcomes--Fidelity

    Time frame: At least once for each six month treatment group.

    Supervisor observations of sessions will be assessed for fidelity using a LIKERT scale that includes preparedness (0-3), Facilitation (0-11), Engagement (0-6) time management (0-1) and Documentation (0-1).

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Karasz, PhD

CONTACT

[email protected]

3478435652

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Georgetown University
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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