DepressionAIMDiVNCT05783531
Accessing Innovative Mental Health Services for Depression in Vietnam
A study testing VMood and Enhanced treatment as usual in people with Depression and Anxiety Disorders, run by Simon Fraser University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety Disorders
- What is being tested?
- VMood and Enhanced treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Score of >4 on PHQ-9 indicating depression caseness
- consent to participate and complete all measures
Who cannot join
- Cognitive disturbance
- Psychotic symptoms
About this study
Official title: AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam
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
- Being tested
- VMood, Enhanced treatment as usual
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMoodOther
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.
Enhanced treatment as usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: VMood |
| Control | Other | 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. Receives: Other: Enhanced treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9) - change in depression scores
A brief (9-item) measure for diagnosing and measuring severity of depression
Measured: Monthly from baseline until three months, with a follow-up at six months
Generalized Anxiety Disorder (GAD-7) - change in anxiety scores
A brief (7-item) measure for assessing generalized anxiety disorder
Measured: Monthly from baseline until three months, with a follow-up at six months
Secondary outcomes (3)
WHO Quality of Life- Brief (WHOQOL-BREV)
To measure the effect of the intervention on quality of life
Measured: Three months, with a follow up at six months
Fast Alcohol Screening Test (FAST)
To measure changes in the use of alcohol products
Measured: Three months, with a follow up at six months
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Adapted
To measure changes in the use of tobacco products
Measured: Three months, with a follow up at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start31 Mar 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge cluster randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, Ministry of Labour, Invalids and Social Affairs (MOLISA): Vietnam
- Responsible party
- Principal investigator, John O'Neil, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783531
- Sponsor's protocol ID
- SFU ORS 26172
- Other IDs
- R-TTS-2205-52454
- Acronym
- AIMDiV
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37669289
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam
- ClinicalTrials.gov ID
- NCT05783531
- Acronym / sponsor ID
- AIMDiV / SFU ORS 26172
- Conditions
- Depression, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, Ministry of Labour, Invalids and Social Affairs (MOLISA): Vietnam
- Study start
- 31 Mar 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: VMoodThis 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. |
| Control | Other | Other: Enhanced treatment as usualThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Score of >4 on PHQ-9 indicating depression caseness
- consent to participate and complete all measures
Key exclusion criteria (2 listed)
- Cognitive disturbance
- Psychotic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VMoodVMood 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. | Other | Intervention |
| Enhanced treatment as usualParticipants 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. | Other | Control |
Primary outcome
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
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
3 secondary outcomes
WHO Quality of Life- Brief (WHOQOL-BREV)
Time frame: Three months, with a follow up at six months
Fast Alcohol Screening Test (FAST)
Time frame: Three months, with a follow up at six months
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Adapted
Time frame: Three months, with a follow up at six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 37669289Chau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing VMood and Enhanced treatment as usual in people with Depression and Anxiety Disorders, run by Simon Fraser University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) - change in depression scores (time frame: Monthly from baseline until three months, with a follow-up at six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05783531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.