Accessing Innovative Mental Health Services for Depression in Vietnam (AIMDiV)

AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Anxiety Disorders
• Intervention / Treatment: Other: VMood; Other: Enhanced treatment as usual

• Study Type: Interventional
• Enrollment (Anticipated): 336
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Score of >4 on PHQ-9 indicating depression caseness
• consent to participate and complete all measures

Exclusion Criteria:

• Cognitive disturbance
• Psychotic symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
Other: Control; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-5L	For cost-effectiveness analysis; to estimate health-related quality of life	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	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	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.	Three months, with a follow up at six months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): March 31, 2023
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): March 31, 2026

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: SFU ORS 26172; R-TTS-2205-52454 (Other Grant/Funding Number: Grand Challenges Canada)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No