Anxiety, Culture Specific Symptoms, Depression, Economic Vulnerability
Conditions
Keywords
Depression treatment, Cash Transfer, Problem Management Plus, Poverty Alleviation
Brief 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.
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.
Sponsors
University of Massachusetts, Worcester
International Centre for Diarrhoeal Disease Research, Bangladesh
Georgetown University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
In this trial, participants, interventionists, and outcome assessors will be blinded to details of the trial design, alternate interventions and randomization assignment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-45 2. 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 3. Family willingness to participate in the program 4. Basic literacy as measured by ability to read a simple sentence; 5. A score \>=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale) at baseline
Exclusion criteria
1. Pregnancy at screen; 2. Cognitive or physical impairment precluding participation 3. Plans to relocate or to travel for \> 1 month during 18 M period. 4. Household debt greater than 70,000 Taka
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive symptoms at 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| 18-Month Relapse | 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. |
| Depression at 12 and 18 months | 12 and 18 months | Changes between PHQ-9 and Baseline at other time points: 12 and 18 months |
| Economic vulnerability Index | Baseline, 12, and 18 Months | A composite index of economic vulnerability including a variety of indicators such as income, debt, and food insecurity. |
| Anxiety | 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. |
| Function | 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. |
| Change in Quality of Life | 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. |
| Tension Scale | 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. |
Countries
Bangladesh
Contacts
CONTACTAlison Karasz, PhD
PRINCIPAL_INVESTIGATORAlison Karasz, PhD
UMass Chan Medical School
Outcome results
None listed