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临床试验/NCT05783531
NCT05783531尚未招募不适用

AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam

Simon Fraser University0 个研究点目标入组 336 人开始时间: 2023年3月31日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

John O'Neil

Professor

Simon Fraser University

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