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

NCT04491045 | Completed DMC

• 1 other identifier: 1R01MH112630-01A1
• Study Type: interventional
• Target: 1,382
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

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

Outcome Measures

Primary Outcomes (4)

• 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).

  24 months

• 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).

  24 months

• 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.

  24 months

• 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.

  6 months

Secondary Outcomes (5)

• Provider Participation

  12 months

• Provider Implementation Quality

  24 months

• Implementation Barriers and Facilitators

  24 months

• Change in Patient Functioning

  6 months

• Change in Patient Family Functioning

  6 months

Study Arms (3)

Community-Engaged Learning Collaborative (CELC)

EXPERIMENTAL

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)

Other: Workshop Training on Multicomponent Collaborative Care for Depression; Other: Supervision; Other: Community-Engaged Learning Collaborative

Enhanced Supervision (ES)

EXPERIMENTAL

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)

Other: Workshop Training on Multicomponent Collaborative Care for Depression; Other: Supervision

Usual Implementation (UI)

ACTIVE COMPARATOR

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.

Other: Workshop Training on Multicomponent Collaborative Care for Depression

Interventions

Workshop Training on Multicomponent Collaborative Care for Depression 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.

Also known as: Workshop Training on Stepped collaborative care program for depression

Community-Engaged Learning Collaborative (CELC); Enhanced Supervision (ES); Usual Implementation (UI)

Supervision 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

Also known as: Coaching

Community-Engaged Learning Collaborative (CELC); Enhanced Supervision (ES)

Community-Engaged Learning Collaborative 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.

Also known as: Continuous Quality Improvement

Community-Engaged Learning Collaborative (CELC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Participants:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi University of Public Health: collaborator
• City University of New York, School of Public Health: lead

Study Sites (2)

Commune Health Stations

Bắc Giang, Vietnam

Location

Commune Health Stations

Phú Thọ, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 37507720 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders

Interventions

Organization and Administration

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

• Victoria Ngo, PhD

  City University of New York

  PRINCIPAL INVESTIGATOR

• Minh V Hoang, MD

  Hanoi University of Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants are offered depression care services at the CHS, therefore participants are not aware of the different implementation supports provided to the supervisors.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Innovation in Mental Health

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: July 29, 2020
• Study Start: December 1, 2021
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)