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Accessing Innovative Mental Health Services for Depression in Vietnam (AIMDiV)

Primary Purpose

Depression, Anxiety Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VMood
Enhanced treatment as usual
Sponsored by
Simon Fraser University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Score of >4 on PHQ-9 indicating depression caseness consent to participate and complete all measures Exclusion Criteria: Cognitive disturbance Psychotic symptoms

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Intervention

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Patient Health Questionnaire (PHQ-9) - change in depression scores
    A brief (9-item) measure for diagnosing and measuring severity of depression
    Generalized Anxiety Disorder (GAD-7) - change in anxiety scores
    A brief (7-item) measure for assessing generalized anxiety disorder

    Secondary Outcome Measures

    WHO Quality of Life- Brief (WHOQOL-BREV)
    To measure the effect of the intervention on quality of life
    Fast Alcohol Screening Test (FAST)
    To measure changes in the use of alcohol products
    Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Adapted
    To measure changes in the use of tobacco products

    Full Information

    First Posted
    March 8, 2023
    Last Updated
    March 23, 2023
    Sponsor
    Simon Fraser University
    Collaborators
    Grand Challenges Canada, Ministry of Labour, Invalids and Social Affairs (MOLISA): Vietnam
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05783531
    Brief Title
    Accessing Innovative Mental Health Services for Depression in Vietnam
    Acronym
    AIMDiV
    Official Title
    AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 31, 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Simon Fraser University
    Collaborators
    Grand Challenges Canada, Ministry of Labour, Invalids and Social Affairs (MOLISA): Vietnam

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Anxiety Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Stepped-wedge cluster randomized
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    336 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    VMood
    Intervention Description
    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
    Intervention Name(s)
    Enhanced treatment as usual
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Patient Health Questionnaire (PHQ-9) - change in depression scores
    Description
    A brief (9-item) measure for diagnosing and measuring severity of depression
    Time Frame
    Monthly from baseline until three months, with a follow-up at six months
    Title
    Generalized Anxiety Disorder (GAD-7) - change in anxiety scores
    Description
    A brief (7-item) measure for assessing generalized anxiety disorder
    Time Frame
    Monthly from baseline until three months, with a follow-up at six months
    Secondary Outcome Measure Information:
    Title
    WHO Quality of Life- Brief (WHOQOL-BREV)
    Description
    To measure the effect of the intervention on quality of life
    Time Frame
    Three months, with a follow up at six months
    Title
    Fast Alcohol Screening Test (FAST)
    Description
    To measure changes in the use of alcohol products
    Time Frame
    Three months, with a follow up at six months
    Title
    Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Adapted
    Description
    To measure changes in the use of tobacco products
    Time Frame
    Three months, with a follow up at six months
    Other Pre-specified Outcome Measures:
    Title
    EQ-5D-5L
    Description
    For cost-effectiveness analysis; to estimate health-related quality of life
    Time Frame
    Three months, with a follow up at six months
    Title
    Health Economic Assessment (HEA) - Adapted
    Description
    For cost-effectiveness analysis; to estimate costs attributable to health resource utilization
    Time Frame
    Three months, with a follow up at six months
    Title
    Work Productivity and Activity Impairment Questionnaire: Depression (WPAID:D)
    Description
    For cost-effectiveness analysis; to measure indirect costs attributable to potential productivity gains
    Time Frame
    Three months, with a follow up at six months
    Title
    System Usability Scale (SUS)
    Description
    To assess the usability of the VMood app. The System Usability Scale (SUS) is an industry standard, validated 10-item Likert-type scale with five response options for measuring usability with 0 (strongly disagree) to 4 (strongly agree). Item scores are summed and the total is multiplied by 2.5. The composite score (between 0 and 100) provides an indicator of perceived usability - a higher score means better perceived ease of use. Research shows a score >68 is considered above average. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
    Time Frame
    Three months, with a follow up at six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Accessing Innovative Mental Health Services for Depression in Vietnam

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