Clinical trial NCT06598579: Evaluation of MBCT Implemented in Vietnamese Buddhist Pagoda
Official title: Evaluation of the Effectiveness of Mindfulness-Based Cognitive Therapy for Depression, Implemented in Vietnamese Buddhist Pagoda
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Quality of Life
Keywords: Depression
Mindfulness
Buddhist meditation
MBCT
Vietnam
task-shifting
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: VNU University of Education
name: National Institute of Mental Health (NIMH)
First posted: 2024-09-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PHQ-9 (Patient Health Questionnaire - 9)
timeFrame: From pre-treatment Baseline assessment (T1) , to 4 months post-baseline (T4) post-treatment follow-up
Secondary outcomes:
measure: Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire)
timeFrame: From pre-treatment Baseline assessment (T1) , to 4 months post-baseline (T4) post-treatment follow-up
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: VNU University of Education
Study officials:
References: