Accessing Innovative Mental Health Services for Depression in Vietnam

Depression Clinical Trial

— AIMDiV  

Official title:

AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05783531
• Other study ID #: SFU ORS 26172
• Secondary ID: R-TTS-2205-52454
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2023
• Source: Simon Fraser University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 336
• Est. completion date: March 31, 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Score of >4 on PHQ-9 indicating depression caseness

• consent to participate and complete all measures

Exclusion Criteria:

• Cognitive disturbance

• Psychotic symptoms

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Other:
• VMood
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.
• Enhanced 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Simon Fraser University	Grand Challenges Canada, Ministry of Labour, Invalids and Social Affairs (MOLISA): Vietnam

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EQ-5D-5L	For cost-effectiveness analysis; to estimate health-related quality of life	Three months, with a follow up at six months
Other	Health Economic Assessment (HEA) - Adapted	For cost-effectiveness analysis; to estimate costs attributable to health resource utilization	Three months, with a follow up at six months
Other	Work Productivity and Activity Impairment Questionnaire: Depression (WPAID:D)	For cost-effectiveness analysis; to measure indirect costs attributable to potential productivity gains	Three months, with a follow up at six months
Other	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.	Three months, with a follow up at six months
Primary	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
Primary	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	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
Secondary	Fast Alcohol Screening Test (FAST)	To measure changes in the use of alcohol products	Three months, with a follow up at six months
Secondary	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