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Evaluation of MBCT Implemented in Vietnamese Buddhist Pagoda

Study acronym: MBCT-VN
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 23, 2025 (before its estimated August 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Start date: Oct 15, 2025 to Feb 15, 2026
    • Primary completion date: Jul 1, 2026 to Aug 15, 2026
    • Study completion date: Aug 1, 2026 to Oct 15, 2026
    v7
  2. Notable Primary completion date: Nov 30, 2025 to Jul 1, 2026
    • Start date: Jul 15, 2025 to Oct 15, 2025
    • Study completion date: Dec 30, 2025 to Aug 1, 2026
    v6
  3. Notable Start date: May 15, 2025 to Jul 15, 2025
    • Study completion date: Nov 30, 2025 to Dec 30, 2025
    v5
  4. Notable Start date: Apr 15, 2025 to May 15, 2025
    • Primary and study completion dates: Oct 31, 2025 to Nov 30, 2025
    v4
  5. Minor Re-verified, no change to tracked fieldsv3
  6. Notable Start date: Oct 15, 2024 to Apr 15, 2025v2 Show 4 more changesShow less
    • Primary endpoint revised
    • Primary and study completion dates: Jul 1, 2025 to Oct 31, 2025
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoint revised
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06598579
Lead Sponsor Vanderbilt University
Collaborators: VNU University of Education, National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Depressive Symptoms, Quality of Life
Related terms Depression
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov