An interventional study of VMood and Enhanced treatment as usual in Depression and Anxiety Disorders, sponsored by Simon Fraser University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by Simon Fraser University · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
8,590 studies on the registry are indexed under Depression; 1,728 are open to participants now.
This study's planned enrollment of 336 is above the median of 81 across 7,074 interventional studies indexed under Depression.
Browse Depression studies →Simon Fraser University is the lead sponsor of 29 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
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.
Patient Health Questionnaire (PHQ-9) - change in depression scores
A brief (9-item) measure for diagnosing and measuring severity of depression
Time frame: 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
Time frame: Monthly from baseline until three months, with a follow-up at six months
WHO Quality of Life- Brief (WHOQOL-BREV)
To measure the effect of the intervention on quality of life
Time frame: Three months, with a follow up at six months
Fast Alcohol Screening Test (FAST)
To measure changes in the use of alcohol products
Time frame: 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
Time frame: Three months, with a follow up at six months
EQ-5D-5L
For cost-effectiveness analysis; to estimate health-related quality of life
Time frame: Three months, with a follow up at six months
Health Economic Assessment (HEA) - Adapted
For cost-effectiveness analysis; to estimate costs attributable to health resource utilization
Time frame: Three months, with a follow up at six months
Work Productivity and Activity Impairment Questionnaire: Depression (WPAID:D)
For cost-effectiveness analysis; to measure indirect costs attributable to potential productivity gains
Time frame: Three months, with a follow up at six months
System Usability Scale (SUS)
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.
Time frame: Three months, with a follow up at six months
No study locations are listed for this record.
Start is estimated for Mar 2023; primary completion for Sep 2025, 30 months later.
Of 3,476 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 30 months is above that.
Counting every sponsor, half of 3,574 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Simon Fraser University