LIFE-DM Implementation Study: A Mixed Methods Implementation Evaluation of an Integrated Depression and Microfinance Program for Women in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RAND
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Provider Adoption of LIFE-DM and Depression Care - Count
研究概览
简要总结
This is an implementation project to develop a model to support implementation of LIFE-DM, an evidence-based practice (EBP) program that integrates depression management with microfinance services to address both poverty and depression among low-income women in Vietnam. This evaluation is a mixed methods study that will 1) describe the development of community-partnered implementation process, 2) study the effectiveness of the training and implementation support plan on provider and patient outcomes, and 3) identify factors that impact implementation success.
详细描述
Livelihood Integration for Effective Depression Management (LIFE-DM) aims to address the dual challenges of poverty and depression faced by women in Vietnam by integrating evidence-based treatment for depression management and microfinance services. With funding from NIMH, the investigators established initial evidence for the effectiveness of LIFE-DM in reducing depression and improving functioning, social support, self-efficacy, and income at six months. These treatment effects were maintained at twelve months, suggesting that the LIFE-DM program may be an effective strategy to break the cycle of depression and poverty in low-income women.
For the Grand Challenges of Canada (GCC) Transition to Scale Grant, the investigators developed a model to scale up the program in the public health and social system across two provinces, Danang and Thua Thien Hue through 1) the training of local trainers from the psychiatric hospital to support local implementation, 2) development of a supervision model, and 3) use of a learning collaborative.
To evaluate the success of the model, the investigators will conduct a mixed methods implementation study that will assess implementation and patient outcomes according to the RE-AIM framework, as well as identify barriers and facilitators to implementation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •depression - based on Patient Health Questionnaire Total Score = > 9
- •low-income
- •ages 18 - 60
排除标准
- •psychosis risk
- •mania risk
- •substance abuse risk
- •high suicide risk
- •physical disabilities
- •significant cognitive impairments
结局指标
主要结局
Provider Adoption of LIFE-DM and Depression Care - Count
时间窗: one year
Delivery of LIFE-DM and depression care components (Counts of depression care components delivered - # of screening, assessment, LIFEDM, individual therapy, medication, loans)
Provider Adoption of LIFE-DM and Depression Care - Percentage
时间窗: one year
Delivery of LIFE-DM and depression care components (% of depression care components delivered - screening, assessment, LIFEDM, individual therapy, medication, loans based on eligible cases)
Patient Depression Scores (PHQ) Change from Baseline to 6 month
时间窗: 0, 6 months
Patients will be assessed for depression using self-reported depression measure (PHQ). The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores are used and they range from 0 to 27, with PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
次要结局
- Implementation Barriers and Facilitators(one year)
- Change in Patient Functioning(0 and 6 months)
- Provider Participation(0-12 months)
- Provider Implementation Quality(throughout the study implementation period, about 1 year)
- Change in Patient Family Functioning(0 and 6 months)