An interventional study of Manualized Group Based Psychotherapy and Poverty Alleviation in Depression, Economic Vulnerability and Anxiety, sponsored by University of Massachusetts, Worcester. Recruiting at 1 site in Bangladesh. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's planned enrollment of 600 is above the median of 84 across 6,718 interventional studies indexed under Depression.
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Exclusion Criteria:
Participants in the control group will receive: 1) 6-sessions of a manualized group based psychotherapy treatment. The treatment is adapted from a WHO program called Problem Management Plus (PM+). PM+ includes 4 evidence based strategies: problem solving; increasing social support; behavioral activation; and relaxation through deep breathing; 2) 4 support group meetings. The intervention is delivered by trained non professional peers.
Behavioral: Manualized Group Based Psychotherapy
The experimental arm includes 2 elements: 1. The 6-ssesion psychotherapy intervention described above. 2. A poverty alleviation intervention that 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.
Behavioral: Manualized Group Based Psychotherapy · Other: Poverty Alleviation
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.
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.
Change in Depressive symptoms at 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.
Time frame: 6 Months
18-Month Relapse
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.
Time frame: 18 months
Depression at 12 and 18 months
Changes between PHQ-9 and Baseline at other time points: 12 and 18 months
Time frame: 12 and 18 months
Economic vulnerability Index
A composite index of economic vulnerability including a variety of indicators such as income, debt, and food insecurity.
Time frame: Baseline, 12, and 18 Months
Anxiety
Anxiety symptoms as measured on the General Anxiety Disorder scale - a seven item questionnaire with scores from 0-21. Higher scores indicate more anxiety.
Time frame: Baseline, 6 Months, 12 Months, and 18 Months
Function
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.
Time frame: Baseline, 6 Months, 12 Months, and 18 Months
Change in Quality of Life
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.
Time frame: Baseline, 6 Months, 12 Months, and 18 Months
Tension Scale
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.
Time frame: Baseline, 6 Months, 12 Months, 18 months
Implementation Outcomes--Adoption
The number of participants attending \>=1 treatment session/number of participants randomized. Based on recruitment and study records.
Time frame: Baseline + 30 days
Implementation Outcomes--Feasibility
Percent of participants attending \>= 70 percent of intervention sessions (7 sessions) - based on study records.
Time frame: 6 months
Implementation outcomes--Fidelity
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).
Time frame: At least once for each six month treatment group.
Plan to share: Yes — We will create a deidentified dataset and it is our intention that these data be readily accessible and used. We will collaborate with and make our data available to other researchers for additional/secondary analyses. Formal data sharing agreements will be developed to guide and encourage further data mining of the proposed datasets for various purposes. All such data requests will be approved though by the investigative team, including the International Center for Diarrhoeal Disease Research (ICDDRB), to help ensure ethical use of the data.
Supporting information: Analytic code
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University of Massachusetts, Worcester