Effectiveness of Behavioral Activation Group Therapy for Patients With Depression at the Community in Thanh Hoa (not yet)

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.

Study Overview

• Status: Completed
• Conditions: Depression - Major Depressive Disorder
• Intervention / Treatment: Behavioral: Behaviral activation group therapy

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Thanh Hóa, Vietnam
    • Hanoi Medical University Thanh Hoa Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• Exclusion criteria included severe physical illness, severe mental disorders, substance use disorders, epilepsy, dementia, intellectual disability, physical disabilities, psychotic symptoms (e.g., paranoia or hallucinations), or severe suicidal ideation requiring urgent referral.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Active Comparator: Behaviral activation group; 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; 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.; Other Names: BAG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological distress	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.	assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Activation	Behavioral activation was measured using the Behavioral Activation for Depression Scale-Short Form (BADS-SF). The BADS-SF is a 9-item measure designed to capture change in activation and avoidance over the previous week, which aligns with the core targets of behavioral activation treatment. Items are rated from 0 (not at all) to 6 (completely), yielding a total score from 0 to 54, with higher scores indicating greater behavioral activation and lower avoidance. In this study, internal consistency was acceptable, with Cronbach's alpha of 0.70.	assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.
Resilience Coping	Resilience coping was assessed using the Brief Resilience Coping Scale (BRCS-4). The BRCS-4 includes 4 items reflecting adaptive coping strategies when facing stress or adversity, such as creative problem-solving and the ability to grow through difficult situations. Each item is rated from 1 to 5, resulting in a total score from 4 to 20, with higher scores reflecting greater resilient coping. The instrument was developed and widely applied by Sinclair and Wallston since 2004. The BRCS has shown good psychometric properties in Vietnamese samples. In this study, Cronbach's alpha for the BRCS was 0.82.	assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.
Health-related quality of life	Health-related quality of life (HRQoL) was measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument. The EQ-5D-5L includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety or depression. Each dimension is rated on a 5-point Likert scale, ranging from no problem (1) to extreme problem (5). Health states were converted into a utility score using the Vietnamese EQ-5D-5L value set. Utility scores range from -0.5115 to 1, where 1 represents full health, and higher scores indicate better HRQoL.	assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up

Collaborators and Investigators

• Sponsor: Hanoi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: depression; primary care; behavioral activation group
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: IRB00003121; Myriad USA (Other Identifier: BasicNeeds)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) will be shared, including demographic characteristics (e.g., age, sex), baseline clinical measures, intervention allocation, and outcome data (e.g., depression and anxiety scores) collected at all assessment time points.
• IPD Sharing Time Frame: assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No