Accessing Innovative Mental Health Services for Depression in Vietnam

NCT ID: NCT05783531

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

VMood

Intervention Type: 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.

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.

Group Type: OTHER

Enhanced treatment as usual

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Grand Challenges Canada

OTHER

Sponsor Role: collaborator

Ministry of Labour, Invalids and Social Affairs (MOLISA): Vietnam

UNKNOWN

Sponsor Role: collaborator

Simon Fraser University

OTHER

Sponsor Role: lead

Responsible Party

John O'Neil

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 37669289 (View on PubMed)

Other Identifiers

R-TTS-2205-52454

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SFU ORS 26172

Identifier Type: -

Identifier Source: org_study_id