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Completed

NCT Number: NCT07527312

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanoi Medical University Thanh Hoa Branch

Thanh Hóa, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: BAG

Primary outcomes

  1. Depressive symptom severity

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

    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.

Secondary outcomes

  1. Psychological distress

    Time frame: assessments 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.

Other outcomes

  1. Behavioral Activation

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

    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.

  2. Resilience Coping

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

    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.

  3. Health-related quality of life

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

    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.

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Registry information

Acronym: not yet

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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