Effectiveness of Behavioral Activation Group Therapy for Patients With Depression at the Community in Thanh Hoa
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 242
- Locations
- 1
- Primary Endpoint
- Depressive symptom severity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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.
Arms & Interventions
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
Participants in the intervention arm received 8-week behavioral activation (BA) group program comprising interactive sessions with structured practical assignments
Intervention: Behaviral activation group therapy (Behavioral)
Outcomes
Primary Outcomes
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
- Psychological distress(assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.)