Clinical trial NCT05783531: Accessing Innovative Mental Health Services for Depression in Vietnam
Official title: AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Anxiety Disorders
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Ministry of Labour, Invalids and Social Affairs (MOLISA): Vietnam
First posted: 2023-03-24
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-wedge cluster randomized
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9) - change in depression scores
timeFrame: Monthly from baseline until three months, with a follow-up at six months
measure: Generalized Anxiety Disorder (GAD-7) - change in anxiety scores
timeFrame: Monthly from baseline until three months, with a follow-up at six months
Secondary outcomes:
measure: WHO Quality of Life- Brief (WHOQOL-BREV)
timeFrame: Three months, with a follow up at six months
measure: Fast Alcohol Screening Test (FAST)
timeFrame: Three months, with a follow up at six months
measure: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Adapted
timeFrame: Three months, with a follow up at six months
Other outcomes:
measure: EQ-5D-5L
timeFrame: Three months, with a follow up at six months
measure: Health Economic Assessment (HEA) - Adapted
timeFrame: Three months, with a follow up at six months
measure: Work Productivity and Activity Impairment Questionnaire: Depression (WPAID:D)
timeFrame: Three months, with a follow up at six months
measure: System Usability Scale (SUS)
timeFrame: Three months, with a follow up at six months
Locations:
Study officials:
References: