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

• ClinicalTrials.gov Identifier: NCT05783531
• Recruitment Status: Not yet recruiting
• First Posted: March 24, 2023
• Last Update Posted: March 24, 2023
• Sponsor: Simon Fraser University
• Collaborators: Grand Challenges Canada; Ministry of Labour, Invalids and Social Affairs (MOLISA): Vietnam
• Information provided by (Responsible Party): John O'Neil, Simon Fraser University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression; Anxiety Disorders	Other: VMood; Other: Enhanced treatment as usual	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 336 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Stepped-wedge cluster randomized
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam
• Estimated Study Start Date: March 31, 2023
• Estimated Primary Completion Date: September 2025
• Estimated Study Completion Date: March 31, 2026

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

1. Patient Health Questionnaire (PHQ-9) - change in depression scores [ Time Frame: 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
2. Generalized Anxiety Disorder (GAD-7) - change in anxiety scores [ Time Frame: Monthly from baseline until three months, with a follow-up at six months ]
   A brief (7-item) measure for assessing generalized anxiety disorder

Secondary Outcome Measures :

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

Other Outcome Measures:

1. EQ-5D-5L [ Time Frame: Three months, with a follow up at six months ]
   For cost-effectiveness analysis; to estimate health-related quality of life
2. Health Economic Assessment (HEA) - Adapted [ Time Frame: Three months, with a follow up at six months ]
   For cost-effectiveness analysis; to estimate costs attributable to health resource utilization
3. Work Productivity and Activity Impairment Questionnaire: Depression (WPAID:D) [ Time Frame: Three months, with a follow up at six months ]
   For cost-effectiveness analysis; to measure indirect costs attributable to potential productivity gains
4. System Usability Scale (SUS) [ Time Frame: 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.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Cognitive disturbance
• Psychotic symptoms

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: John O'Neil, Professor, Simon Fraser University
• ClinicalTrials.gov Identifier: NCT05783531
• Other Study ID Numbers: SFU ORS 26172; R-TTS-2205-52454 ( Other Grant/Funding Number: Grand Challenges Canada )
• First Posted: March 24, 2023
• Last Update Posted: March 24, 2023
• Last Verified: March 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Depressive Disorder; Anxiety Disorders; Behavioral Symptoms; Mood Disorders; Mental Disorders