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

Hanoi Medical University242 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

242

Conditions

Depression - Major Depressive Disorder

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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