Evaluation of MBCT Implemented in Vietnamese Buddhist Pagoda

NCT06598579 | Not Yet Recruiting DMC

• 2 other identifiers: NIHR21MH127563R21MH127563
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Background Depression presents a substantial public health burden around the world. Evidence-based psychotherapy treatments (psychotherapy EBT) for depression exist but access is often limited, particularly in low- and middle-income countries (LMIC), by mental health stigma and scarcity of professional mental health providers. One approach to address these issues is mental health task-shifting, transferring mental health services from highly trained mental health professionals operating in formal mental health settings, to non-mental health professionals or lay people receiving focused training in a particular mental health program, operating in non-mental health settings (e.g., schools; religious settings). Purposes of the present study are to (a) adapt Mindfulness-Based Cognitive Therapy (MBCT) for depression - a psychotherapy depression EBT - for implementation in Vietnamese Buddhist pagoda in VN (MBCT-VN); and (b) conduct a cluster-randomized clinical trial of MBCT-VN, implemented in Vietnamese Buddhist pagoda. Vietnamese Buddhist pagoda are selected as the task-shifting site because they represent a potentially low stigma, culturally-congruent site for task-shifting implementation of mindfulness-based mental health treatments. Methods MBCT was adapted for the present project through a collaborative team process, producing the MBCT-VN program. The clinical trial evaluation will involve a cluster-randomized comparison between (a) the treatment condition MBCT-VN, and (b) a treatment-as-usual control condition, Buddhist meditation as implemented in pagoda. To reduce cross-group contamination, pagoda will be the unit of assignment. Outcome assessments will include four timepoints across four months. One hundred and sixty adult participants will be recruited from eight (four treatment; four control) Buddhist pagoda in the Hanoi, Vietnam area. The primary outcome will be level of depression (Patient Health Questionnaire-9: PHQ-9); the secondary outcome will be quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire: Q-LES-Q). The study will assess and evaluate several Implementation Science factors (e.g., Treatment Acceptability) as well as other potential moderators of treatment effects, and potential mediators such as increase in depression mental health literacy and decrease in depression stigma. Inferential analyses will use a general linear mixed model framework with a latent growth curve framework, with propensity covariates.

Conditions

Depressive Symptoms; Quality of Life

Keywords

Depression; Mindfulness; Buddhist meditation; MBCT; Vietnam; task-shifting

Outcome Measures

Primary Outcomes (1)

• PHQ-9 (Patient Health Questionnaire - 9)

  This scale measures level of depression symptoms. Scores range from 0 to 27, with higher scores indicating higher levels of depression (worse outcome)

  From pre-treatment Baseline assessment (T1) , to 4 months post-baseline (T4) post-treatment follow-up

Secondary Outcomes (1)

• Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire)

  From pre-treatment Baseline assessment (T1) , to 4 months post-baseline (T4) post-treatment follow-up

Study Arms (2)

MBCT-VN

EXPERIMENTAL

Behavioral: Mindfulness-based Cognitive Therapy

Buddhist Meditation - Treatment-as-Usual

PLACEBO COMPARATOR

Behavioral: Treatment-as-usual involving Buddhist meditation

Interventions

Treatment-as-usual involving Buddhist meditation BEHAVIORAL

MBCT and other mindfulness interventions were originally derived from Buddhist meditation, modifed to be non-secular and focused on treatment of depression and other mental health and behavioral problems rather than on spiritual development. In the present study, a treatment-as-usual condition involving Buddhist meditation will be used. The project will assess the characteristics of the Buddhist meditation delivered for the control group participants at pagoda meditation retreats but will not influence this control condition in any way.

Buddhist Meditation - Treatment-as-Usual

Mindfulness-based Cognitive Therapy BEHAVIORAL

Mindfulness-Based Cognitive Therapy (MBCT) is a form of psychotherapy that combines principles of cognitive therapy with mindfulness practices focused on increasing non-judgemental awareness of the present moment. It was designed to help individuals, particularly those with depression, stop rumination and a cycle of negative thought patterns that lead to emotional distress including depression. It is a well established depression EBT. The Vietnamese version of the program (MBCT-VN) is a group treatment involving from five to ten participants (depending on how many participants are able to be recruited) per group.

Also known as: MBCT

MBCT-VN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• PHQ-9 greater than or equal to 10
• PHQ-9 sadness item greater than or equal to 1, and / or PHQ-9 anhedonia item greater than or equal to 1

You may not qualify if:

• PHQ-9 greater than or equal to 20
• suicidal intent
• mania or psychosis

Sponsors & Collaborators

• Vanderbilt University: lead
• VNU University of Education: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

VNU University of Education

Hanoi, Vietnam

Location

Related Publications (1)

• Weiss B, Vu V, Dang HM, Trung L. Protocol for a cluster-randomized clinical trial to evaluate the effectiveness of mindfulness-based cognitive therapy for depression, implemented in Vietnamese Buddhist pagoda. BMC Psychol. 2025 May 20;13(1):527. doi: 10.1186/s40359-025-02754-5.

  PMID: 40394634 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Bahr Weiss, PhD

CONTACT

615-829-6624; bahr.weiss@vanderbilt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because a cluster-randomization design is being used, with random assignment at the pagoda-level to avoid cross-group contamination, masking is not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 19, 2024
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)