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

ConditionsDepression Economic Vulnerability Anxiety Culture Specific Symptoms

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorUniversity of Massachusetts, Worcester

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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 intervention
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.

Treatment groups

600 Participants

are divided into 2 treatment groups

Group A: Depression Treatment (DT)Active comparator 1 intervention

Group B: Integrated InterventionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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.