Protocol for a cluster-randomized clinical trial to evaluate the effectiveness of mindfulness-based cognitive therapy...

Depression presents a substantial world-wide public health burden. Although evidence-based treatments exist, the majority of individuals with depression do not receive evidence-based treatments, particularly in low-and-middle-income countries, due to (a) scarcity of mental health professionals, and (b) mental health-related stigma. One approach addressing these issues is task-shifting, transfer of service provision from fully-trained mental health professionals to non-mental health professionals and lay people receiving focused training in a specific mental health service. Effective task-shifting providers can be trained in a few months, addressing personnel scarcity, and mental health task-shifting services generally occur outside formal mental health sites, reducing stigma. Mindfulness-based interventions such as MBCT are evidence-based treatments for depression. Mindfulness-based interventions are derived from Buddhist meditation but are secular, focused on enhancing emotional and cognitive functioning rather than spiritual growth. The first study goal was to adapt MBCT for use in Buddhist pagoda in Vietnam, a Southeast Asian low- and middle-income country. The second goal is to conduct a cluster-randomized clinical trial of MBCT-VN, implemented in Vietnamese Buddhist pagoda.

A cluster-randomized clinical trial design will compare treatment (MBCT-VN) and control (treatment-as-usual: Buddhist Meditation) conditions, with pagoda the cluster unit. Because group assignment occurs at the pagoda-level, assessment and assignment to condition will be non-blinded. There will be five longitudinal assessments: Screening, and T1, T2, T3, and T4 across four months from baseline. One hundred and sixty participants will be recruited for eight Buddhist pagoda (four treatment; four control) around Hanoi, Vietnam. The primary outcome is depression (PHQ-9), the secondary outcome quality of life (Q-LES-Q). Several Implementation Science constructs such as Treatment Acceptability and Program Attitudes will be assessed.

This study has several limitations. To reduce cross-group contamination, randomization occurs at the pagoda-level, significantly reducing the number of randomization units, and requiring participants and data collectors to be non-blind to condition. Also, no long-term follow-up assessment is currently planned. Nonetheless this study, one of the first to assess mindfulness-based interventions implemented in Buddhist pagoda, should provide at least preliminary information regarding the potential value of pagoda as a task-shifting site for implementation of mindfulness-based intervention for depression.

ClinicalTrials.gov: NCT06598579. 25-Mar-2025.