Accessing Innovative Mental Health Services for Depression in Vietnam
- Conditions
- DepressionAnxiety Disorders
- Interventions
- Other: VMoodOther: Enhanced treatment as usual
- Registration Number
- NCT05783531
- Lead Sponsor
- Simon Fraser University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 336
- Score of >4 on PHQ-9 indicating depression caseness
- consent to participate and complete all measures
- Cognitive disturbance
- Psychotic symptoms
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention VMood This arm will receive the VMood digital mental health intervention. This consists of bibliotherapy that is delivered via a smartphone app, with coaching support provided by social workers for a duration of three months. The skills in the workbook are grounded in principles of Cognitive Behavioural Therapy. Control Enhanced treatment as usual This arm will receive enhanced treatment as usual, which consists of regular care as provided by primary care centres and a brief introduction video about depression via the app. The control arm will receive the intervention after the intervention arm has completed the intervention period.
- Primary Outcome Measures
Name Time Method Generalized Anxiety Disorder (GAD-7) - change in anxiety scores 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 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
- Secondary Outcome Measures
Name Time Method WHO Quality of Life- Brief (WHOQOL-BREV) Three months, with a follow up at six months To measure the effect of the intervention on quality of life
Fast Alcohol Screening Test (FAST) Three months, with a follow up at six months To measure changes in the use of alcohol products
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Adapted Three months, with a follow up at six months To measure changes in the use of tobacco products