Accessing Innovative Mental Health Services for Depression in Vietnam

Study Overview
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Brief Summary
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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.

Official Title
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AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam

Conditions
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Depression, Anxiety Disorders

Intervention / Treatment
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* Other: VMood
* Other: Enhanced treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Score of >4 on PHQ-9 indicating depression caseness consent to participate and complete all measures Exclusion Criteria: Cognitive disturbance Psychotic symptoms

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stepped-wedge cluster randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Other: VMood<br>* VMood is a digital mental health intervention adapted from an evidence-based in-person intervention. It uses supported self-management approaches, consisting of bibliotherapy (the Antidepressant Skills Workbook) and supportive coaching from a social worker that are provided via the smartphone app. The individual is supported in the use of the skills over the course of three months. The skills in the workbook are grounded in principles of Cognitive Behavioural Therapy.<br>|
| Other: Control<br>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. | Other: Enhanced treatment as usual<br>* Participants in the control arm will receive enhanced treatment as usual in the form of usual care from primary care centres and a brief introduction to depression video through the VMood app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) - change in depression scores | A brief (9-item) measure for diagnosing and measuring severity of depression | Monthly from baseline until three months, with a follow-up at six months | 
| Generalized Anxiety Disorder (GAD-7) - change in anxiety scores | A brief (7-item) measure for assessing generalized anxiety disorder | Monthly from baseline until three months, with a follow-up at six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO Quality of Life- Brief (WHOQOL-BREV) | To measure the effect of the intervention on quality of life | Three months, with a follow up at six months | 
| Fast Alcohol Screening Test (FAST) | To measure changes in the use of alcohol products | Three months, with a follow up at six months | 
| Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Adapted | To measure changes in the use of tobacco products | Three months, with a follow up at six months |