Evaluation of MBCT Implemented in Vietnamese Buddhist Pagoda (MBCT-VN)

December 20, 2025 updated by: Bahr Weiss, Vanderbilt University

Evaluation of the Effectiveness of Mindfulness-Based Cognitive Therapy for Depression, Implemented in Vietnamese Buddhist Pagoda

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Detailed Description

The study has three research aims and hypotheses:

  • 1: To investigate the effects of MBCT-VN on the primary outcome, level of depression symptoms. It is hypothesized that the Treatment Group (MBCT-VN) will show significantly more reduction than the Control Group in PHQ-9 (depression) scores.
  • 2: To investigate the effects of MBCT-VN on the secondary outcome, level of quality of life. It is hypothesized that the Treatment Group (MBCT-VN) will show significantly more increase than the Control Group in Q-LES-Q (quality of life) scores.
  • 3: To investigate change from pre-treatment to post-treatment depression symptoms. It is hypothesized that the Treatment Group (MBCT-VN) will show pre-treatment to post-treatment change on the PHQ-9 that does not differ significantly from other within-group change in MBCT depression treatment evaluations, using statistical benchmarking methodology.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • 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 Contact

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • VNU University of Education
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBCT-VN
Behavioral: Mindfulness-based Cognitive Therapy
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.
Other Names:
  • MBCT
Placebo Comparator: Buddhist Meditation - Treatment-as-Usual
Behavioral: Treatment-as-usual involving Buddhist meditation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PHQ-9 (Patient Health Questionnaire - 9)
Time Frame: From pre-treatment Baseline assessment (T1) , to 4 months post-baseline (T4) post-treatment follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire)
Time Frame: From pre-treatment Baseline assessment (T1) , to 4 months post-baseline (T4) post-treatment follow-up
This scale measures quality of life and functional impairment. Scores range from 13 to 65, with higher scores indicating higher levels of life functioning (better outcome).
From pre-treatment Baseline assessment (T1) , to 4 months post-baseline (T4) post-treatment follow-up

Collaborators and Investigators

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

Sponsor

Vanderbilt University

Collaborators

National Institute of Mental Health (NIMH)
VNU University of Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

February 15, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

September 15, 2024

First Submitted That Met QC Criteria

September 15, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 20, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIHR21MH127563
  • R21MH127563 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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