Accessing Innovative Mental Health Services for Depression in Vietnam

Last updated: March 23, 2023
Sponsor: Simon Fraser University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Depression

Panic Disorders

Anxiety Disorders

Treatment

N/A

Clinical Study ID

NCT05783531
SFU ORS 26172
R-TTS-2205-52454
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Cognitive disturbance
  • Psychotic symptoms

Study Design

Total Participants: 336
Study Start date:
March 31, 2023
Estimated Completion Date:
March 31, 2026