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

April 14, 2026 updated by: Hanoi Medical University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
242

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.
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.
assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.
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.
assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hanoi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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