Evaluation of MBCT Implemented in Vietnamese Buddhist Pagoda

Not Applicable

Not yet recruiting

• Conditions: Depressive Symptoms; Quality of Life
• Interventions: Behavioral: Mindfulness-based Cognitive Therapy; Behavioral: Treatment-as-usual involving Buddhist meditation

• Registration Number: NCT06598579
• Lead Sponsor: Vanderbilt University

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.

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 Timeline

• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-09-15
• Study First Posted: 2024-09-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-23
• Study Start: 2025-05-15
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBCT-VN	Mindfulness-based Cognitive Therapy	-
Buddhist Meditation - Treatment-as-Usual	Treatment-as-usual involving Buddhist meditation	-

Primary Outcome Measures

Name	Time	Method
PHQ-9 (Patient Health Questionnaire - 9)	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)

Secondary Outcome Measures

Name	Time	Method
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	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).

Trial Locations

Locations (1)

VNU University of Education; 🇻🇳 Hanoi, Vietnam