Effectiveness of Behavioral Activation Group Therapy for Patients With Depression at the Community in Thanh Hoa

NCT07527312 | Completed

• 2 other identifiers: IRB00003121Myriad USA
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate whether the 8-week BA group therapy delivered at commune health stations (CHSs) improves depressive symptom severity, psychological distress, behavioral activation, resilient coping, and health-related quality of life (HRQoL) compared with control care, from post-intervention through 9 months of follow-up, and whether effects vary across follow-up time points. By using a cluster-randomized trial design in routine CHS settings with supervised delivery by trained commune health staff, this study addresses an important evidence gap on scalable, community-based depression care in Vietnam. The investigators further reasoned that brief, structured psychological interventions that can be implemented within primary care services may help expand access to evidence-based depression care where specialist resources are limited.

Conditions

Depression - Major Depressive Disorder

Keywords

depression; behavioral activation group; primary care

Outcome Measures

Primary Outcomes (1)

• Depressive symptom severity

  Depressive symptom severity were measured with the 9-item Patient Health Questionnaire (PHQ-9), which is a self-report instrument assessing the frequency of core depressive symptoms over the past two weeks. Each item is rated on a 4-point scale from 0 to 3, yielding a total score ranging from 0 to 27, with higher scores indicating greater symptom severity. The PHQ-9 has been widely used and psychometrically evaluated across diverse populations, including in Vietnam. Internal consistency in the present sample was acceptable, with Cronbach's alpha of 0.71.

  assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up

Secondary Outcomes (1)

• Psychological distress

  assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.

Other Outcomes (3)

• Behavioral Activation

  assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.

• Resilience Coping

  assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.

• Health-related quality of life

  assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up

Study Arms (2)

No intervention

NO INTERVENTION

Participants in the control group received a psychoeducation session and an informational leaflet outlining depression symptoms and referral information, including the Thanh Hoa psychiatric hospital hotline and address.

Behaviral activation group

ACTIVE COMPARATOR

Participants in the intervention arm received 8-week behavioral activation (BA) group program comprising interactive sessions with structured practical assignments

Behavioral: Behaviral activation group therapy

Interventions

Behaviral activation group therapy BEHAVIORAL

Behaviral activation group therapy is an empirically validated, structured psychological treatment for depression that encourages individuals to re-engage with meaningful activities and increase contact with rewarding experiences within their natural environment. The eight-week-long BAG program is designed to teach subjects in these main themes: Doing healthy activities, Appropriate Activities and Life Balance, Goal Setting and Activity Planning, Problem-Solving Skills, The Importance of Social Connection, Effective Communication Skills, and Relapse Prevention and Graduation.

Also known as: BAG

Behaviral activation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants were adults aged 18-65 years in six participating communes (Quang Trach, Quang Hop, Quang Truong, Quang Duc, Quang Giao, Quang Loc) and having PHQ-9 scores ≥10 at CHS screening.

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical University Thanh Hoa Branch

Thanh Hóa, Vietnam

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants in the intervention arm received 8-week group behavioral activation (BA) program comprising eight weekly interactive sessions with structured practical assignments. Sessions were delivered at CHSs by trained commune health staff under ongoing supervision from Thanh Hoa Psychiatric Hospital. All those healthcare providers were trained in BA group therapy in 80 hours by two PIs who were trained and applied BA intervention for individuals and groups in both clinical and community settings for more than 10 years. Intervention fidelity was supported through session recordings and checklist-based supervision feedback.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: August 1, 2024
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 17, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.
• Access Criteria: De-identified individual participant data (IPD), including demographic data, outcome measures, and relevant study variables, will be made available to qualified researchers for secondary analyses. Supporting documents such as the study protocol, statistical analysis plan, and informed consent form will also be available. Data will be accessible upon reasonable request to the principal investigator, subject to approval of a research proposal and execution of a data sharing agreement. Data will be available beginning 6 months after publication and ending 5 years following publication.

Locations

VN (1)