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Clinical Trials/NCT05783531
NCT05783531
Not Yet Recruiting
N/A

AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam

Simon Fraser University0 sites336 target enrollmentMarch 31, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
Simon Fraser University
Enrollment
336
Primary Endpoint
Generalized Anxiety Disorder (GAD-7) - change in anxiety scores
Status
Not Yet Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 31, 2023
End Date
March 31, 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John O'Neil

Professor

Simon Fraser University

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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)

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