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

NCT ID: NCT04491045

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-06-30

Brief 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. 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.

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when implementation support is provided and 2) Sustainment Phases, when study funded implementation supports are withdrawn.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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Community-Engaged Learning Collaborative (CELC)

The 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)

Group Type: EXPERIMENTAL

Workshop Training on Multicomponent Collaborative Care for Depression

Intervention Type: OTHER

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.

Supervision

Intervention Type: OTHER

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 Collaborative

Intervention Type: OTHER

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.

Enhanced Supervision (ES)

This 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)

Group Type: EXPERIMENTAL

Workshop Training on Multicomponent Collaborative Care for Depression

Intervention Type: OTHER

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.

Supervision

Intervention Type: OTHER

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

Usual Implementation (UI)

Usual 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.

Group Type: ACTIVE_COMPARATOR

Workshop Training on Multicomponent Collaborative Care for Depression

Intervention Type: OTHER

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.

Interventions

Workshop Training on Multicomponent Collaborative Care 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.

Intervention Type: OTHER

Supervision

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

Intervention Type: OTHER

Community-Engaged Learning Collaborative

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.

Intervention Type: OTHER

Other Intervention Names

Workshop Training on Stepped collaborative care program for depression; Coaching; Continuous Quality Improvement

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanoi University of Public Health

OTHER

Sponsor Role: collaborator

City University of New York, School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Victoria Ngo

Director of the Center for Innovation in Mental Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victoria Ngo, PhD

Role: PRINCIPAL_INVESTIGATOR

City University of New York

Minh V Hoang, MD

Role: STUDY_DIRECTOR

Hanoi University of Public Health

Locations

Commune Health Stations

Bắc Giang, , Vietnam

Commune Health Stations

Phú Thọ, , Vietnam

Countries

Vietnam

References

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.

Reference Type: DERIVED

PMID: 37507720 (View on PubMed)

Other Identifiers

1R01MH112630-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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