Evaluation of MBCT Implemented in Vietnamese Buddhist Pagoda
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness-based Cognitive Therapy, Treatment-as-usual involving Buddhist meditation.
- Who it may be relevant to
- Registry conditions: Depressive Symptoms, Quality of Life. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effectiveness of Mindfulness-Based Cognitive Therapy for Depression, Implemented in Vietnamese Buddhist Pagoda
Overview
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.
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.
Interventions
- 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 tr - 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 in
Primary outcome measures
- PHQ-9 (Patient Health Questionnaire - 9) [Time frame: From pre-treatment Baseline assessment (T1) , to 4 months post-baseline (T4) post-treatment follow-up]
Secondary outcome measures (1)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Vietnam · 1 center
- VNU University of Education — Hanoi
Publications
- 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
Identifiers
NCT: NCT06598579 · NIHR21MH127563 · R21MH127563