Development of an Integrated Microfinance and Depression Care Program for Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RAND
- 入组人数
- 166
- 试验地点
- 4
- 主要终点
- Change in Depression Score from the Patient Health Questionnaire
研究概览
简要总结
The study evaluates LIFE-DM, an integrated microfinance and collaborative care intervention by comparing it to enhanced treatment as usual (national guideline antidepressant care and referral to microfinance resources) in Vietnam. Intervention effects at baseline, 6 month, and 12 month follow-up on patient outcomes, including depression, anxiety, quality of life, functioning, self-efficacy, satisfaction, and income will be compared across the two conditions.
详细描述
Depression is one of the largest contributors to the world's health burden. Prior work in the Partners in Care study has shown that evidence-based service delivery programs for depression can improve health outcomes in depressed patients, and especially in minorities, largely overcoming disparities in outcomes from care between whites and minorities. Effective treatments exist, but they do not reach many depressed individuals, especially in resource-poor communities--ethnic minorities, rural residents in the United States, and individuals in most of the developing world.
Women, in particular, are at risk for depression and poverty. Integrating programs that treat depression and address livelihood concerns may improve engagement in depression treatment and improve mental health and functioning for patients in low-resource settings. The proposed study would integrate depression care with existing "microfinance" programs, which provide poverty-alleviation services including small loans, savings programs, and vocational training to women.
This project will (1) conduct qualitative studies of barriers and facilitators of women's successful use of existing depression care and microfinance programs; (2) adapt and integrate the depression care and microfinance services; (3) train Women's Union facilitators to deliver the integrated depression care and microfinance program; and conduct evaluation of LIFE-DM program to assess acceptability, feasibility, and preliminary effectiveness. The non-randomized control trial compares the integrated microfinance and collaborative care intervention with enhanced treatment as usual (national guideline antidepressant care and referral to microfinance resources) at the Women's Union in Danang city in Vietnam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •depression, low-income
排除标准
- •psychosis, mania, substance abuse, high suicide risk, physical disabilities, significant cognitive impairments
研究组 & 干预措施
Integrated Depression/Microfinance Group
LIFE-DM is a Depression and Microfinance integrated program using behavior activation and problem solving therapy applied to both depression and livelihood. Livelihood support include microfinance loans, personal finance, and income-generation skills.
干预措施: Integrated Depression/Microfinance Group (Behavioral)
Integrated Depression/Microfinance Group
LIFE-DM is a Depression and Microfinance integrated program using behavior activation and problem solving therapy applied to both depression and livelihood. Livelihood support include microfinance loans, personal finance, and income-generation skills.
干预措施: Livelihood Support (Other)
Integrated Depression/Microfinance Group
LIFE-DM is a Depression and Microfinance integrated program using behavior activation and problem solving therapy applied to both depression and livelihood. Livelihood support include microfinance loans, personal finance, and income-generation skills.
干预措施: Treatment as Usual (Other)
Treatment as Usual
Currently treatment as usual in this province includes national guidelines for antidepressant care for depression and referral for microfinance/livelihood programs
干预措施: Treatment as Usual (Other)
结局指标
主要结局
Change in Depression Score from the Patient Health Questionnaire
时间窗: 0, 6, 12 months
The PHQ-9 is a nine-item validated tool measuring depressive symptoms based on DSM-IV criteria. The answers are rated on a scale from zero (not at all) to three (nearly every day). Total scores range from 0-27, subdivided into five categories of depression severity: 1 to 4 is minimal; 5 to 9 is mild; 10 to 14 is moderate; 15 to 19 is moderate-severe; and 20 and above is severe. The PHQ-9 has been widely used internationally including in Vietnam.
次要结局
- Change in Social Support Index from Medical Outcome Study Social Support Survey(0, 6, 12 months)
- Number of Participants with Depression Diagnosis - MINI International Neuropsychiatric Interview, Version 6.0 (MINI)(0, 6, 12 months)
- Number of Participants Demonstrating Mental Health Literacy with Depression Vignette(0, 12 months)
- Change in Anxiety Symptom Score from Generalized Anxiety Disorder (GAD-7) Scale(0, 6, 12 months)
- Change in Behavior Activation Score from the Behavior Activation for Depression Scale Short Form (BADS-SF)(0, 6, 12 months)
- Treatment Acceptability Score from Help-Seeking Behavior Questionnaire(0, 6, 12 months)
- Depression Stigma Score from the Depression Stigma Questionnaire(0, 6, 12 months)
- Change in Quality of Life Score from Quality of Life and Enjoyment and Satisfaction Questionnaire(0, 6, 12 months)
- Change in Self-Efficacy Score from Self Efficacy Survey(0, 6, 12 months)
- Change in health and mental health functioning scores from Medical Outcomes Study Short Form Health Survey (SF-12)(0, 6, 12 months)
- Change in household wealth indicators from Economic Well-Being Inventory(0, 6, 12 months)
- Change in number and type of income generating activities from the Employment and business Activities Questionnaire(0, 6, 12 months)
- Social Capital Score from Social Capital Assessment Tool(0, 6, 12 months)
- Total Score Client Service Satisfaction Questionnaire(0, 6, 12 months)