Accessing Innovative Mental Health Services for Depression in Vietnam

NCT05783531 | Not Yet Recruiting DMC

• 2 other identifiers: SFU ORS 26172R-TTS-2205-52454
• Study Type: interventional
• Target: 336
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• WHO Quality of Life- Brief (WHOQOL-BREV)

  Three months, with a follow up at six months

• Fast Alcohol Screening Test (FAST)

  Three months, with a follow up at six months

• Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Adapted

  Three months, with a follow up at six months

Other Outcomes (4)

• EQ-5D-5L

  Three months, with a follow up at six months

• Health Economic Assessment (HEA) - Adapted

  Three months, with a follow up at six months

• Work Productivity and Activity Impairment Questionnaire: Depression (WPAID:D)

  Three months, with a follow up at six months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

OTHER

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

Interventions

VMood OTHER

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.

Intervention

Enhanced treatment as usual OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive disturbance
• Psychotic symptoms

Sponsors & Collaborators

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

Related Publications (1)

• Chau LW, Murphy JK, Nguyen VC, Xie H, Lam RW, Minas H, Zheng Y, Krebs E, Hayashi K, Dao S, Nguyen X, Duong VA, Fiume E, O'Neil J. Evaluating the effectiveness and cost-effectiveness of a digital, app-based intervention for depression (VMood) in community-based settings in Vietnam: Protocol for a stepped-wedge randomized controlled trial. PLoS One. 2023 Sep 5;18(9):e0290328. doi: 10.1371/journal.pone.0290328. eCollection 2023.

  PMID: 37669289 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stepped-wedge cluster randomized

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 24, 2023
• Study Start: March 31, 2023
• Primary Completion: September 1, 2025
• Study Completion: March 31, 2026
• Last Updated: March 24, 2023

Record last verified: 2023-03