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DepressionNCT04491045

Implementation Strategies for Task-Shifting Depression Care Depression Care in Vietnam

A study testing Workshop Training on Multicomponent Collaborative Care for Depression, Supervision and Community-Engaged Learning Collaborative in people with Depression, run by City University of New York, School of Public Health at 2 sites in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a Hybrid Implementation-Effectiveness study that will primarily test the implementation strategies on provider adoption and implementation quality in three Vietnam provinces. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression
What is being tested?
Workshop Training on Multicomponent Collaborative Care for Depression, Supervision and Community-Engaged Learning Collaborative
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,382 participants
Where
2 sitesVietnam
Study dates
1 Dec 2021to 30 Jun 2025
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient Participants:
  • 18-65 years of age
  • PHQ-9 score of 10 or above
  • Planning to receive care at an eligible community health station
  • Able to provide written informed consent
  • Provider Participants:
  • General practitioners, nurses, social workers, and other qualified health care providers at a selected community health station selected by CHS Directors for depression care project.

Who cannot join

  • Patient Participants:
  • Psychosis
  • Mania
  • Substance Abuse
  • High suicide risk
  • Provider Participants: Cannot commit to full participation for the two year project period. Examples of reasons for potential barriers to commitment include leaving due to pursuit of advanced formal training at universities, anticipation of promotion or change in job status, anticipation of relocation.

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites
  • Commune Health Stations

    Bắc Giang

  • Commune Health Stations

    Phú Thọ

Other trials in Vietnam

About this study

Official title: Randomized Control Trial on Implementation Strategies for Task-Shifting Depression Care in Vietnam

The study is a Hybrid Implementation-Effectiveness study that will primarily test the implementation strategies on provider adoption and implementation quality in three Vietnam provinces. Secondarily, the effectiveness of the multicomponent collaborative care model for depression intervention on patient outcomes will be tested. A cluster randomized control trial design, with a mixed-methods approach, will be used to assess the effectiveness of the three implementation strategies on both organizational and provider implementation outcomes and patient effectiveness outcomes.

Read the detailed description

Depression is a prevalent and debilitating mental health condition that is relatively common in almost all countries around the world, including Vietnam, and is one of the largest burdens of health. Although effective treatments exist, many with depression do not receive appropriate care. In Vietnam, numerous barriers exist to implementation of evidence-based mental health services but recently there has been growing recognition of the need to address the treatment gap. In order to close the treatment gap for depression, within the health care system, effective depression care needs to be scaled up to a wider network of community health stations that are supported by the local psychiatric hospitals. However, it is unclear what the best implementation model is for supporting depression care in primary care settings.

The aim of this project is to compare three different models of implementation support for depression care in two Vietnam provinces: 1) Supported Implementation when implementation support is provided and 2) Sustainment Phases, when study funded implementation supports are withdrawn. The providers in select community health stations (CHSs) within these two provinces) will receive training workshops and varying levels of implementation support based on the implementation models (described below) to provide depression care to their patients. The three models are : 1) Usual Implementation (UI) - a basic depression workshop, limited technical assistance to set up the program, and implementation toolkits 2) Enhanced Supervision (ES) - UI + ongoing structured supportive supervision; and 3) Community Engaged Learning Collaborative (CELC) - ES + community collaborative learning.

The three models will be evaluated based on the RE-AIM framework, which will be assessed using implementation and patient outcomes across supported implementation phase and sustainment phase. Both implementation and patient outcomes will be assessed during the sustainment phase after resources are withdrawn to evaluate the sustainability of the program. Knowledge gained from this project will be used to inform implementation of depression care services across Vietnam, and help increase access and quality of depression care.

Conditions
Depression
Being tested
Workshop Training on Multicomponent Collaborative Care for Depression, Supervision, Community-Engaged Learning Collaborative
Keywords
Behavior Activation, Problem solving therapy, Depression Treatment, Depression care integration, Implementation research, Task shifting, Collaborative care, Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders, Antidepressive Agents, Psychotropic Drugs
Medical subject headings
Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Workshop Training on Multicomponent Collaborative Care for DepressionOther

    Also called Workshop Training on Stepped collaborative care program for depression

    Hybrid Workshop Trainings on Stepped collaborative care model for depression that involves using a team-based approach to integrating depression care components (screening, psychoeducation, Behavior Activation therapy, and antidepressant medications) into primary care settings. This integration involves task-shifting mental health tasks from mental health specialist to community providers at the commune health stations.

  • SupervisionOther

    Also called Coaching

    Ongoing supervision and coaching is provided to community health providers by local mental health specialist from the provincial psychiatric hospital for 6-9 months

  • Community-Engaged Learning CollaborativeOther

    Also called Continuous Quality Improvement

    The CELC group will receive support for continuous quality improvement using a province-wide learning collaborative that will meet monthly for 3 months, followed by bi-monthly meetings for 12 months.

Study groups in NCT04491045
Study groupRoleWhat they receive
Community-Engaged Learning Collaborative (CELC)ExperimentalThe CELC arm is an integration of community engagement and learning collaborative approach which involves province-wide collaborative meetings for commune health stations (6 CHSs for each province) randomized into the CELC implementation condition. CELC CHSs will meet monthly initially for 3 months, followed by bi-monthly meetings for 12 months to engage in continuous quality improvement process, track implementation goals, problem solve implementation barriers, and engage in cross-site learning. This is in addition to usual implementation condition (supervision, workshops, technical assistance, and evidence-based toolkit)
Receives: Other: Workshop Training on Multicomponent Collaborative Care for Depression; Other: Supervision; Other: Community-Engaged Learning Collaborative
Enhanced Supervision (ES)ExperimentalThis is an evidence-based training approach which involves 6-9 months of ongoing group supervision support from psychiatric hospital mental health specialist (psychiatrist, psychiatric nurse, or psychologist) for each community health station randomized to the ES condition. Supervision approach is structured and involves observation of sessions, feedback on fidelity and quality. Supervision support will be provided biweekly initially and monthly after completion of one practice case. This is in addition to usual implementation condition (workshops, technical assistance, and evidence-based toolkit)
Receives: Other: Workshop Training on Multicomponent Collaborative Care for Depression; Other: Supervision
Usual Implementation (UI)Active comparatorUsual Implementation (UI) Control intervention that will be enhanced usual implementation and includes hybrid training workshops on basic implementation and training supports for Multicomponent Collaborative Care for Depression program, which is an evidence-based stepped collaborative care intervention for integrating depression care into primary care settings. It consists of six components: routine screening, diagnostic assessment, psychoeducation, antidepressant medication, adherence management, behavior activation therapy. This implementation and training supports includes a series of online training modules, weekly webinars, and 3 one-day in-person workshops on collaborative care for depression (MCCD), limited technical assistance, and toolkit.
Receives: Other: Workshop Training on Multicomponent Collaborative Care for Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Provider Adoption of Project Dep and Depression Care- Count

    Delivery of Project Dep and depression care components (Counts of depression care components delivered - # of screening, assessment, individual therapy, medication).

    Measured: 24 months

  2. Provider Adoption of LIFE-DM and Depression Care - Percentage

    Delivery of Project Dep and depression care components (% of depression care components delivered - screening, assessment, individual therapy, medication).

    Measured: 24 months

  3. Change in Provider Competence Scores

    Providers will be assessed by their supervisors for their overall competence in delivering the components of depression care every 6 months for 24 months. There are 18 items related to depression care skills (e.g., screening, psychoeducation, behavior activation, problem solving, medication management, etc.), Each item is scored on a 3 point scale from 1 to 3 (1-needs improvement, 2-satisfactory, 3-excellent). A total of 54 points can be obtained, with higher score indicating higher competence. N/A is used when a particular skill is not expected of that provider (i.e., community health workers are not expected to assess or manage medication). These ratings are conducted by supervisors at 0, 6, 12, and 24 months.

    Measured: 24 months

  4. Patient Depression Scores (PHQ) Change from Baseline to 6 month

    Patients will be assessed for depression using self-reported depression measure (PHQ). The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores are used and they range from 0 to 27, with PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.

    Measured: 6 months

Secondary outcomes (5)
  1. Provider Participation

    Provider Participation in Training Activities (Count / % of workshop attendance, supervision meetings, and learning collaborative meetings).

    Measured: 12 months

  2. Provider Implementation Quality

    Supervisor Rated LIFE-DM session adherence and quality. Supervision of groups involve observation of group facilitation by supervisors, who provide adherence and quality ratings of sessions. Each item is assessed on a 4 point scale - 0 (did not do), 1 (delivered but poor), 2 (average), and 3 (excellent). The items are averaged to provide a session specific score of adherence and quality. Session adherence /quality scores are used to compute provider level adherence and quality averages. Each supervisor was expected to provide ratings for a minimum of 3 assessments out of the 12 group sessions. These session ratings are used to compute the average adherence and quality score for each provider. Higher scores indicate higher adherence and quality.

    Measured: 24 months

  3. Implementation Barriers and Facilitators

    Qualitative Interviews of Providers and Program Staff to Assess Barriers and Facilitators of Implementation

    Measured: 24 months

  4. Change in Patient Functioning

    Patient - SF-12 - Change in functioning from baseline to 6 months. The SF-12 Health Survey is a 12-item subset of the SF-36v2™ that measures the same eight domains of health (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health). It is a brief, reliable measure of overall health status. Scores are calibrated so that 50 is the average score or norm. This norm-based score allows comparison among the three surveys and across the more than 19,000 studies published in the past 20 years.

    Measured: 6 months

  5. Change in Patient Family Functioning

    Patient - McMaster Family Functioning Scale - Change from baseline to 6 months. This is a 12 item scale (on a 4 point scale). the average score across items is used to determine the degree of problematic family functioning. A score of 2.00 or above indicates problematic family functioning. The higher the score, the more problematic the family member perceives the family's overall functioning.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2020
  2. Study start1 Dec 2021
  3. Primary completion30 Apr 2025
  4. Study completion30 Jun 2025

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,382 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04491045
Sponsor's protocol ID
1R01MH112630-01A1
Status last verified
Dec 2025
First submitted
13 May 2020
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ngo VK, Vu TT, Vu QA, McBain R, Yu G, Nguyen NB, Mai Thi Nguyen H, Ho HT, Van Hoang M. Study protocol for type II hybrid implementation-effectiveness trial of strategies for depression care task-sharing in community health stations in Vietnam: DEP Project. BMC Public Health. 2023 Jul 28;23(1):1450. doi: 10.1186/s12889-023-16312-4.

    PubMed 37507720

Questions about this trial

What is this clinical trial studying?

A study testing Workshop Training on Multicomponent Collaborative Care for Depression, Supervision and Community-Engaged Learning Collaborative in people with Depression, run by City University of New York, School of Public Health at 2 sites in Vietnam.

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 7 inclusion and 6 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: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Provider Adoption of Project Dep and Depression Care- Count (time frame: 24 months). The study lists 4 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 NCT04491045, 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 16 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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