Depression - Major Depressive Disordernot yetNCT07527312
Effectiveness of Behavioral Activation Group Therapy for Patients With Depression at the Community in Thanh Hoa
A study testing Behaviral activation group therapy in people with Depression - Major Depressive Disorder, run by Hanoi Medical University at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Behaviral activation group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Behaviral activation group therapy
- Keywords
- depression, behavioral activation group, primary care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviral activation group therapyBehavioural
Also called BAG
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
| Behaviral activation group | Active comparator | Participants in the intervention arm received 8-week behavioral activation (BA) group program comprising interactive sessions with structured practical assignments Receives: Behavioral: Behaviral activation group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up
Secondary outcomes (1)
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.
Measured: assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Aug 2024
- Primary completion30 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in the intervention arm received 8-week group behavioral activation (BA) program comprising eight weekly interactive sessions with structured practical assignments. Sessions were delivered at CHSs by trained commune health staff under ongoing supervision from Thanh Hoa Psychiatric Hospital. All those healthcare providers were trained in BA group therapy in 80 hours by two PIs who were trained and applied BA intervention for individuals and groups in both clinical and community settings for more than 10 years. Intervention fidelity was supported through session recordings and checklist-based supervision feedback.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527312
- Sponsor's protocol ID
- IRB00003121
- Other IDs
- Myriad USA
- Acronym
- not yet
- Status last verified
- Sep 2025
- First submitted
- 7 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Behavioral Activation Group Therapy for Patients With Depression at the Community in Thanh Hoa
- ClinicalTrials.gov ID
- NCT07527312
- Acronym / sponsor ID
- not yet / IRB00003121
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- depression, behavioral activation group, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants in the intervention arm received 8-week group behavioral activation (BA) program comprising eight weekly interactive sessions with structured practical assignments. Sessions were delivered at CHSs by trained commune health staff under ongoing supervision from Thanh Hoa Psychiatric Hospital. All those healthcare providers were trained in BA group therapy in 80 hours by two PIs who were trained and applied BA intervention for individuals and groups in both clinical and community settings for more than 10 years. Intervention fidelity was supported through session recordings and checklist-based supervision feedback.
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Behaviral activation group | Active comparator | Behavioral: Behaviral activation group therapyParticipants in the intervention arm received 8-week behavioral activation (BA) group program comprising interactive sessions with structured practical assignments |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behaviral activation group therapyAlso: BAGBehaviral 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. | Behavioural | Behaviral activation group |
Primary outcome
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.
1 secondary outcome
Psychological distress
Time frame: assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviral activation group therapy in people with Depression - Major Depressive Disorder, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptom severity (time frame: assessments at five time points, including baseline, 8-week post-intervention, 3-month, 6-month, 9-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.