AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 336
- 主要终点
- Generalized Anxiety Disorder (GAD-7) - change in anxiety scores
研究概览
简要总结
This stepped wedge, randomized controlled trial (RCT) will test the effectiveness of a digital mental health intervention (VMood) adapted from an evidence-based in-person intervention. The in-person intervention is based on principles of Cognitive Behavioural Therapy and uses a supported self-management approach consisting of a patient skills workbook and supportive coaching by a non-specialist provider. It was developed in Canada and shown to be effective in the Vietnamese context in a previous RCT conducted by the research team. The digital adaptation (VMood) is delivered via a Smartphone app the research team developed in Vietnam, in close collaboration with the Institute of Population, Health and Development (PHAD) in Vietnam.
The digital intervention will be delivered at the community level in 8 Vietnamese provinces, with remote coaching provided via the app by social workers. The primary outcome measure for the study is the Patient Health Questionnaire (PHQ-9), which screens for depression caseness. The investigators will also include the Generalized Anxiety Disorder(GAD-7) measure, as symptoms of anxiety commonly co-occur with depression. Secondary outcome measures will include the WHO Quality of Life-Brief (WHOQUAL-BREV), FAST Alcohol Screening Test (FAST), the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) adapted to assess tobacco use only. The investigators will also conduct a cost-effectiveness analysis (CEA) using the 5-level EQ-5D (EQ-5D-5L), the Health Economic Assessment (HEA) adapted for the Vietnamese health context, and Work Productivity and Activity Impairment Questionnaire: Depression (WPAID:D). Finally, the System Usability Scale (SUS) will be used to assess VMood usability.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Score of >4 on PHQ-9 indicating depression caseness
- •consent to participate and complete all measures
排除标准
- •Cognitive disturbance
- •Psychotic symptoms
结局指标
主要结局
Generalized Anxiety Disorder (GAD-7) - change in anxiety scores
时间窗: Monthly from baseline until three months, with a follow-up at six months
A brief (7-item) measure for assessing generalized anxiety disorder
Patient Health Questionnaire (PHQ-9) - change in depression scores
时间窗: Monthly from baseline until three months, with a follow-up at six months
A brief (9-item) measure for diagnosing and measuring severity of depression
次要结局
- WHO Quality of Life- Brief (WHOQOL-BREV)(Three months, with a follow up at six months)
- Fast Alcohol Screening Test (FAST)(Three months, with a follow up at six months)
- Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Adapted(Three months, with a follow up at six months)
研究者
John O'Neil
Professor
Simon Fraser University
