Anxiety Disorders, Depression
Conditions
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.
Interventions
OTHERVMood
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.
OTHEREnhanced treatment as usual
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.
Sponsors
Grand Challenges Canada
Ministry of Labour, Invalids and Social Affairs (MOLISA): Vietnam
Simon Fraser University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Stepped-wedge cluster randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Score of \>4 on PHQ-9 indicating depression caseness * consent to participate and complete all measures
Exclusion criteria
* Cognitive disturbance * Psychotic symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Work Productivity and Activity Impairment Questionnaire: Depression (WPAID:D) | Three months, with a follow up at six months | For cost-effectiveness analysis; to measure indirect costs attributable to potential productivity gains |
| Health Economic Assessment (HEA) - Adapted | Three months, with a follow up at six months | For cost-effectiveness analysis; to estimate costs attributable to health resource utilization |
| System Usability Scale (SUS) | Three months, with a follow up at six months | To assess the usability of the VMood app. The System Usability Scale (SUS) is an industry standard, validated 10-item Likert-type scale with five response options for measuring usability with 0 (strongly disagree) to 4 (strongly agree). Item scores are summed and the total is multiplied by 2.5. The composite score (between 0 and 100) provides an indicator of perceived usability - a higher score means better perceived ease of use. Research shows a score \>68 is considered above average. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. |
| EQ-5D-5L | Three months, with a follow up at six months | For cost-effectiveness analysis; to estimate health-related quality of life |
Outcome results
None listed