ASHA Bangladesh--An Integrated Intervention to Address Depression in Low Income Rural Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 680
- 主要终点
- Change in Depressive symptoms at 6 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
In this trial, participants, interventionists, and outcome assessors will be blinded to details of the trial design, alternate interventions and randomization assignment.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Depression Treatment (DT)
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.
干预措施: Manualized Group Based Psychotherapy (Behavioral)
Integrated Intervention
The experimental arm includes 2 elements:
- The 6-ssesion psychotherapy intervention described above.
- 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.
干预措施: Manualized Group Based Psychotherapy (Behavioral)
Integrated Intervention
The experimental arm includes 2 elements:
- The 6-ssesion psychotherapy intervention described above.
- 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.
干预措施: Poverty Alleviation (Other)
结局指标
主要结局
Change in Depressive symptoms at 6 Months
时间窗: 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.
次要结局
- Anxiety(Baseline, 6 Months, 12 Months, and 24 Months)
- Function(Baseline, 6 Months, 12 Months, and 24 Months)
- 18-Month Relapse(18 months)
- Depression at 12 and 18 months(12 and 18 months)
- Economic vulnerability Index(Baseline, 12, and 18 Months)
- Anxiety(Baseline, 6 Months, 12 Months, and 18 Months)
- Function(Baseline, 6 Months, 12 Months, and 18 Months)
- Change in Quality of Life(Baseline, 6 Months, 12 Months, and 18 Months)
- Tension Scale(Baseline, 6 Months, 12 Months, 18 months)
研究者
Alison Karasz
Professor
University of Massachusetts, Worcester