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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07527312
Acronym
not yet
Enrollment
242
Registered
2026-04-14
Start date
2024-08-01
Completion date
2025-11-30
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression - Major Depressive Disorder

Keywords

depression, behavioral activation group, primary care

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.

Interventions

BEHAVIORALBehaviral activation group therapy

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.

Sponsors

Hanoi Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Depressive symptom severityassessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-upDepressive 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.

Secondary

MeasureTime frameDescription
Psychological distressassessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.Psychological distress was assessed using the 5-item Brief Symptom Rating Scale (BSRS-5). The BSRS-5 captures common distress symptoms experienced during the previous week, including sleep disturbance, anxiety or tension, irritability, depressed mood, and feelings of inferiority. Items are rated from 0 to 4, producing a total score from 0 to 20, with higher scores indicating more severe distress. The BSRS-5 has demonstrated good reliability and validity in prior studies and has been applied among patients with depression. In this study, Cronbach's alpha for the BSRS-5 was 0.70.

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026