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| ID | Type | Description | Link |
|---|---|---|---|
| 7R01MH127577 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| Georgetown University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depression Treatment (DT) | Active Comparator | 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. |
|
| Integrated Intervention | Experimental | The experimental arm includes 2 elements:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation Outcomes--Adoption | The number of participants attending >=1 treatment session/number of participants randomized. Based on recruitment and study records. | Baseline + 30 days |
| Implementation Outcomes--Feasibility |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alison Karasz, PhD | Contact | 3478435652 | alison.karasz@umassmed.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alison Karasz, PhD | UMass Chan Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Centre for Diarrhoeal Disease Research | Recruiting | Dhaka | Dhaka Division | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14728109 | Background | Greenberg PE, Kessler RC, Birnbaum HG, Leong SA, Lowe SW, Berglund PA, Corey-Lisle PK. The economic burden of depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry. 2003 Dec;64(12):1465-75. doi: 10.4088/jcp.v64n1211. | |
| 16946181 | Background | Kessler RC, Akiskal HS, Ames M, Birnbaum H, Greenberg P, Hirschfeld RM, Jin R, Merikangas KR, Simon GE, Wang PS. Prevalence and effects of mood disorders on work performance in a nationally representative sample of U.S. workers. Am J Psychiatry. 2006 Sep;163(9):1561-8. doi: 10.1176/ajp.2006.163.9.1561. |
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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.
Data will be available indefinitely following the completion of analyses
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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In this trial, participants, interventionists, and outcome assessors will be blinded to details of the trial design, alternate interventions and randomization assignment.
|
| 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. |
|
| 18 months |
| Depression at 12 and 18 months | Changes between PHQ-9 and Baseline at other time points: 12 and 18 months | 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. | 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. | 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. | 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. | 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. | Baseline, 6 Months, 12 Months, 18 months |
Percent of participants attending >= 70 percent of intervention sessions (7 sessions) - based on study records.
| 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). | At least once for each six month treatment group. |
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