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Protocol for a cluster-randomized clinical trial to evaluate the effectiveness of mindfulness-based cognitive therapy for depression, implemented in Vietnamese Buddhist pagoda

BMC Psychology volume 13, Article number: 527 (2025) Cite this article

Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

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

Peer Review reports

Background

Depression presents a substantial public health burden in virtually all countries in which it has been assessed [1, 2]. A number of evidence-based treatments (EBT) for depression exist, including anti-depression medication, and psychological interventions such as behavioral activation, cognitive therapy, and mindfulness-based treatments [3]. Although these treatments, which can be provided jointly, all have relatively high rates of success when administered correctly, psychological treatments can reduce risk of depression recurrence after completion of treatment whereas anti-depressant medication generally do not [3]. Psychological treatments have the disadvantage of requiring higher levels of human resources to administer than medication treatments. Despite such effective treatments, the majority of individuals with significant depression do not receive EBT treatment, particularly in low- and middle-income countries (LMIC), due to (a) a scarcity of trained mental health professionals and mental health facilities, and (b) stigma associated with “mental illness” and its treatment [4].

Task-shifting treatment

One approach used to address both personnel scarcity as well as stigma issues is task-shifting, which is the transfer of service provision from fully trained mental health professionals (e.g., psychiatrists; clinical psychologists; clinical social workers) to non-mental health professionals and lay people receiving focused training in a specific mental health service [5]. Tasking-shifting providers can include general physicians and nurses, lay community health workers, high-school teachers, and essentially any group of persons. Advantages of task-shifting are that a competent provider can be trained in a few months rather than several years. A primary disadvantage is that task-shifting providers have relatively circumscribed skills and generally require ongoing supervision [5]. Research indicates when properly trained and supervised, task-shifting personnel can be highly effective in treating certain mental health problems, including depression [5,6,7,8]. An additional positive aspect of mental health task-shifting services is they generally occur outside the formal mental health system, often at locations typically not associated with mental health (e.g., schools; general medical clinics; religious settings), which when properly implemented can reduce mental health-related stigma [9, 10].

Mindfulness-based (MB) interventions

MB interventions such Acceptance and Commitment Therapy, Mindfulness-Based Cognitive Therapy and others involve training participants in skills designed to increase awareness of current feelings, thoughts, and bodily sensations but without the automatic labeling or judging as “good” or “bad” that often occurs, particularly among people with depression. This can reduce automatic negative emotional reactivity that precipitates or exacerbates affective and other mental health problems [11]. MB interventions are derived from Buddhist meditation but differ in key ways. In brief, Buddhist meditation is focused on spiritual growth whereas MB interventions are secular, focused on enhancing emotional and cognitive functioning. Buddhist meditation requires years to master whereas formal MB training typically runs about two months [12]. MB interventions have been found to be effective at reducing current and recurrence risk for depression as well as other mental health problems [13, 14]. The comprehensive meta-analysis by Goldberg et al. (2018) [13] examined MB intervention efficacy for a range of mental health problems, with 142 samples and 12,005 participants. MB interventions were superior to controls at post-treatment (d = 0.55) and follow-up (d = 0.50), and at both timepoints did not differ significantly from accepted EBT. Positive effects were most consistent for depression, chronic pain, and substance addiction disorders but also found for other domains.

Current project background and goals

The goals of the current project have been (a) to adapt Mindfulness-Based Cognitive Therapy (MBCT), a depression EBT [13], for task-shifting implementation in Vietnamese Buddhist pagoda (MBCT-VN), and to (b) conduct a cluster-randomized clinical trial to assess the effectiveness of the adapted program, labeled MBCT-VN. The focus on implementing MBCT in Vietnamese Buddhist pagoda is designed to provide a low-stigma site for task-shifting implementation of MBCT in Vietnam. Depression is the most prevalent adult mental health disorder worldwide [1, 2]. In virtually all countries in which depression has been assessed, it is identified as a significant public health problem [1, 2], including in Vietnam [15,16,17,18]. Depression is a primary target of the VN National Mental Health Program [19]. The Vietnamese National Guidelines for Diagnosis and Treatment of Mental Illness [20] has noted that the large majority of depression in Vietnam is untreated, largely due to lack of access and service availability. In Vietnam, over half the population identifies as Buddhist [21], with an additional 25% of people involved in pagoda activities such as deceased family member remembrance services [22], suggesting pagoda may be a useful, low stigma site for depression treatment access.

Prior research

Although MB techniques are derived from Buddhist practices and their efficacy established, there has been little actual research on task-shifting implementation of mindfulness-based intervention to Buddhist settings. Han et al. (2012) [23] provided a mental health intervention including MB practices implemented by a Buddhist monk for 9 Cambodian-American refugees. Participants showed significant pre- / post-treatment decreases in PTSD symptoms but there was no control group. Several other research studies including Gosling (1998) [24], Hathirat (1983) [25], and Swaddiwudhipong et al. (1993) [26] have involved Buddhist monks as non-mental health or non-MB intervention providers. Swaddiwudhipong et al. (1993) [26], for instance, reported on use of a Buddhist monk in a Thai anti-smoking campaign but the intervention was not mindfulness-based. Thus, the current project’s focus on task-shifting implementation of MBCT to Vietnamese Buddhist pagoda represents a potentially valuable innovation, wherein mental health task-shifting personnel provide an EBT program congruent with their own training and experience (with Buddhist meditation), outside the health-care and education systems.

MBCT-VN program adaptation

The MBCT-VN program was adapted from standard Mindfulness-Based Cognitive Therapy [27, 28]. MBCT was originally developed for use in clinical settings as an 8-week (1 session/week) program with a 1 day practice retreat [13]. It and similar programs have been adapted for a wide range of settings, including criminal justice settings [29], schools [30], self-help [31], and others. Meta-analysis reviews have generally found successful adaptation. For instance, Virgili’s (2015) [32] meta-analysis of 19 RCT of MB programs adapted for work settings found significant post-treatment (g = 0.68) and follow-up (g = 0.60) effects.

The goals of our adaptation process were to (a) make MBCT compatible for use in Vietnamese culture in general, and (b) in Vietnamese Buddhist pagoda in particular, (c) with task-shifting implementation of the program by Buddhist monks, pagoda parishioners, and other members of the local community. Our adaptation process followed (a) guidelines of Dobkin et al. (2014) [33], who discussed how to maintain essential program elements during cultural adaptations of mindfulness-based psychotherapy, and (b) our own team’s experience adapting mental health programs for Vietnam [6, 7, 34,35,36]. The adaptation process involved a series of focus group discussion meetings with extended team members, including Vietnamese Buddhist monks, parishioners, and local community members. This included review of (a) Buddhist meditation, and MBCT structure and key treatment mechanisms [11, 33, 37]; and (b) group discussion regarding (b1) Vietnamese, Buddhist, and mental health perspectives on depression; (b2) differences between MBCT and Buddhist meditation, in particular as depression interventions, (b3) potential cultural (e.g., stigma), logistical (e.g., pre-existing time commitments at pagoda) and other barriers (e.g., the ability to differentiate MBCT-VN from Buddhist meditation, in order to maintain treatment fidelity), and how they might be resolved to maintain key treatment mechanisms.

Key modifications for MBCT-VN following these discussions included (a) reducing the number of sessions from eight to seven, (b) dropping the standard one-day silent retreat, and (c) reducing the length of the mindfulness practices, in general, from the standard 40 min to 20 min. Given relatively low levels of mental health literacy in general and in particular in regard to depression [38], a key modification involved an increased focus on psychoeducation for depression, including (d) providing a pre-program “information session” with a focus on psychoeducation for depression, (e) increasing the program’s focus on psychoeducation for depression in Session 1, and (f) integrating psychoeducation throughout the program (e.g., increasing the frequency of Facilitator comments regarding the depression-related purpose of various mindfulness activities). Another central modification was (g) a focus on differentiating Buddhist meditation and MBCT, such as having different goals (spiritual growth, vs. control of depression, respectively). This was initiated during the Group Facilitator trainings. Finally, adaptations were made throughout the manual to fit with Vietnamese cultural perspectives. For instance, (h) during advanced mindfulness practices, rather than discussing “thoughts” and their potential impact on emotional functioning, the term “talking to ourself” is used because it is less abstract than “thoughts”. Also, (i) in standard MBCT practice, mindfulness activities are begun with minimal or no introduction, to minimize participants’ pre-conceptualizations about the activities. However, based on the various adaptation meetings, in MBCT-VN participants are provided with a brief introduction to mindfulness activities in order to reduce distracting thoughts related to what the purpose of the activity is.

After the initial manual was developed, a four-day discussion and training workshop was provided to the MBCT-VN Group Facilitators. The background for MBCT and manual contents were presented, including role-play demonstrations with feedback, with the manual revised based on various comments and experiences during the training. After the training Group Facilitators conducted a practice implementation at their pagoda of the seven-week program, with supervised practice implementation.

Study hypotheses

Hypothesis 1

The Treatment Group (MBCT-VN) will show significantly more reduction than the Control Group in PHQ-9 (depression) scores.

Hypothesis 2

The Treatment Group (MBCT-VN) will show significantly more increase than the Control Group in Q-LES-Q (quality of life) scores.

Hypothesis 3

The Treatment Group (MBCT-VN) will show pre- / post-treatment change on the PHQ-9 that does not differ significantly from other within-group change in MBCT evaluations, using statistical benchmarking methodology [39, 40].

Methods

Study design

The study will assess one treatment condition (mindfulness-based cognitive therapy for depression, adapted from Vietnam; MBCT-VN) and one control condition (treatment-as-usual: Buddhist Meditation). The study uses a cluster randomization assignment design to allocate adult participants to the treatment condition or the control condition. Randomization was performed using the SAS 9.4 random number generator. Pagoda has served as the cluster unit, with each pagoda assigned to the treatment condition or the control condition; i.e., all project participants at a particular pagoda will receive either the treatment condition or the control condition. This approach is used rather than participant-level assignment in order to reduce the risk of cross-group contamination within pagoda. Because assignment to group occurs at the pagoda-level, assignment to condition and assessment will be non-blinded. There will be five assessments conducted as part of the RCT: [1] Screening, which will occur after participants have been provided basic information regarding the treatment and control conditions and after they have provided voluntary informed consent; [2] T1 (Timepoint 1), prior to beginning treatment; [3] T2 (Timepoint 2), two weeks after the beginning of treatment (end of Control condition implementation); [4] T3 (Timepoint 3), two months after the beginning of treatment (end of Treatment condition implementation); [5] T4 (Timepoint 4), four months after the beginning of treatment (final follow-up assessment). The study proposal (IRB #25004) was approved by the U.S. FWA IRB (#18223) at Vietnam National University (U.S. IORG5233; U.S. IRB6292).

Sampling, participants, and recruitment

Study participants will be recruited from the local communities of eight Buddhist pagoda (four of which have been assigned to the treatment condition, and four to the control condition) in the general Hanoi area in northern Vietnam. All participants will be adults (age greater than or equal 18 years). Inclusion criteria include: (a) age ≥ 18 years; (b) PHQ-9 depression measure total score 10 to 19; (c) PHQ-9 sadness item and / or anhedonia item ≥ 1; (d) voluntary consent. Exclusion criteria include: (a) PHQ-9 total score ≥ 20; (b) suicide risk; (c) scoring positive on the bipolar disorder screening assessment or the psychosis screening assessment.

The study design has three nested levels: Level 1. Pagoda (8 pagoda: 4 treatment, 4 control); Level 2 nested within Level 1, Participant (N = 160); Level 3 nested with Level 2, Time (N = 4, as the Screening will not be included in the outcome assessment). A total of 160 participants will be recruited, with each treatment group or control group at the pagoda containing up to ten participants. Depending on the number of participants able to be recruited for each group, there will be two or more sequential cohorts per pagoda. The sample size of 160 was chosen based on a power analysis conducted, using the Optimal Design (3.01) [41] software. Using ranges from our research in Vietnam [6, 7, 34] for participant attrition (0–11%), rho (ICC for random clustering effects) (0.00 to 0.05), and effect size estimates (0.47 to 0.68) from meta-analyses of the effects of mindfulness-based interventions [13, 29,30,31,32], with 160 participants clustered in 8 pagoda, the median power = 0.83.

Participant recruitment will occur via announcements posted on bulletin boards outside the pagoda in the nearby community (e.g., in the village “community center”), on pagoda bulletin boards, on pagoda online websites, and on online websites associated with the pagoda (e.g., pagoda members’ Facebook pages). Announcements will provide a brief description of the project, including a (a) short depression psycho-education and (b) short description of the project as an evaluation of MBCT-VN or Buddhist meditation, depending on to which condition the particular pagoda is assigned. The announcement will direct interested persons to obtain further information via (a) an online detailed description of the program and project, accessed either (a1) through a QR code to be scanned by their phone (for persons accessing the announcements on bulletin boards) or (a2) a URL hyperlink (for persons accessing the announcement via a website). The same detailed description of the program and project will also be available (b) via a hardcopy from a staff person at the pagoda. Individuals accessing the information online who are interested in possible participation will complete the screening measures online via a hyperlink to the project data collection system. Persons accessing the information in-person at the pagoda also will complete the screening measures online, with the assistance of the pagoda staff using their phone if necessary. The measures will then be reviewed online within one week by project staff, and the potential participant contacted by project staff via the phone. The phone call will also if necessary obtain details regarding exclusion criteria. Persons not passing exclusion criteria will be interviewed by a psychologist associated with the project. If the exclusion criteria are confirmed, the person will be referred to a local mental health facility which has agreed to provide support for persons not able to be enrolled in the study. Individuals with PHQ below the 10 cutoff, which according to PHQ-9 guidelines indicates sub-clinical levels of depression [42], will be provided with self-help materials and with contact information for obtaining support at a local mental health clinic if desired. Those passing criteria will have the study described in detail over the phone, any questions answered, and the schedule for the program shared. At the end of the “pre-program” meeting at the pagoda (an “information” session providing an overview of the program and depression, but no actual treatment), interested persons will review and if interested sign the consent form.

Experimental conditions

Control group

A “treatment as usual” control condition will be used. Control group participants will be provided training and experience in Buddhist meditation at a “meditation retreat” series at the pagoda in which they are participating. The project will assess the characteristics of the “treatment as usual” condition that control group participants receive (i.e., the content of the mediation sessions that the participant receives at the pagoda; number and length of sessions) but will not be involved in or influence the content of the meditation program.

Treatment group

Treatment group participants will receive the MBCT-VN program, adapted as described above. Each MBCT-VN group will have a Group Facilitator and an Assistant, both of whom will be a local community member, pagoda parishioner, or pagoda monk. The program will consist of seven weekly sessions provided at the pagoda, with scheduling based on the Group Facilitator’s, Assistant’s, and participants’ schedules.

Measures

Data will be collected for sample description purposes, to measure clinical outcomes and potential moderators, and for use with propensity analyses to maximize pre-treatment similarity between the groups within the outcome analyses. Many of the measures have pre-existing published Vietnamese versions (e.g., PHQ-9 [43]; Treatment Acceptability [44]). For those that do not, the research team (which is highly experienced in measure translation and adaptation having adapted for Vietnam a number of widely used measures such as the Strengths and Difficulties Questionnaire [45] and others [46]) translated and adapted the measures following the recommendations of Hambleton [47] and others using a consensus approach to translation and adaptation.

Demographics

Demographic information to be assessed includes (a) age and gender, (b) family circumstances (marital status; children; with whom one lives in the household, etc.); (c) socio-economic status (education level, income level, job status, financial stress); (d) religious affiliation (including no religious involvement or affiliation) and involvement in religious activities; and (e) previous treatment for depression.

Clinical functioning

Five areas related to clinical functioning will be assessed, including (a) Depression: The PHQ-9 [43] self-report questionnaire will be used to assess severity of depression symptoms, as the primary outcome variable. (b) Life functioning: The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [48] will be used to assess life functioning and functional impairment, as a secondary outcome variable. (c) Depression History will be assessed, including (c1) when the current episode began, (c2) the number of prior depression episodes, (c3) how old the person was when the first episode occurred, (c4) how long the most recent episode (excluding the current episode) lasted. (d) Exclusion Criteria assessed will include mania within bipolar disorder, and psychosis, using Vietnamese versions of the Rapid Mood Screener [49] and Psychosis Screening Questionnaire [50], respectively. (e) Depression stigma and depression mental health literacy will be assessed, using the Depression Stigma and Knowledge Questionnaire [51].

Implementation science variables

Three implementation science constructs will be assessed. These include (a) Treatment Acceptability [52], which measures pre-treatment interest and opinions about the program (MBCT-VN, or Buddhist Meditation), based on the preliminary information provided to participants; (b) Treatment Feasibility [53], which measures beliefs about how feasible each of the programs (MBCT-VN, or Buddhist Meditation) is; (c) Program Attitudes, which measures participants’ post-treatment attitudes and reactions to their program, including how useful it was, how feasible it was, etc.

Services received, and help-seeking

Treatment and control participants will report on the number of sessions at the pagoda (MBCT-VN; Buddhist Meditation, respectively) and length of time they attended. They also will report on mental health services and support they sought and received outside the project, using the Help-Seeking Questionnaire [54]. The Help-Seeking Questionnaire scores will be included in analyses as covariates to adjust for external influences on participant functioning.

Statistical analyses

All analyses will be intent-to-treat, using all available data. Missing data will be treated as missing and not estimated. Descriptive statistics will be used to summarize participant characteristics. Inferential analyses to evaluate study hypotheses will use a general linear mixed models framework with latent growth curve model. Nested random factors will include: [1] Pagoda [2], Participant, and [3] Time (linear and quadratic effects). Treatment will be a fixed effect, the primary independent variable (IV). The effect of interest will be the Time X Treatment interaction with linear and quadratic components. Primary dependent variables (DV) will be (in separate analyses) depression (PHQ), and quality of life (Q-LES-Q). We will use propensity covariates [55] to maximize pre-treatment similarity of the treatment and control groups. Potential propensity covariate variables will include (a) the various demographic variables; (b) T1 PHQ-9 and T1 Q-LES-Q, depression history, scores on the exclusion screeners, depression stigma, and mental health literacy; (c) program attitudes. Services received outside the project will be included as separate covariates in analyses. Exploratory moderator analyses will be conducted using the same statistical models. Potential moderators assessed will include age, gender, religious affiliation and involvement, financial stress, severity of depression, and depression history. The Implementation Science variables will be analyzed for descriptive purposes, as well as potential moderators of treatment effects. In addition to these group comparison RCT analyses, the study will conduct benchmarking analyses, comparing within-group improvement within MBCT-VN to benchmarks [39, 40] for within-group improvement of mindfulness-based psychotherapy for treatment of depression. Study results will be communicated via peer-reviewed publications. De-identified data will be available for study replication purposes. Data will be stored online on a fully encrypted server.

Risk classification

The overall risk for this study is believed to be Minimal Risk. The two treatment conditions (MBCT; Buddhist meditation, as a treatment-as-usual condition) are psychosocial interventions that do not involve medication, surgery, etc., and are generally considered low risk (see below). The questionnaires that will be used in the study do not assess trauma or violence, stigmatized experiences (e.g., sexual assualt), or fear-related situations (e.g., phobia; OCD).

MBCT

The clinical risks associated with MBCT and other mindfulness-based psychosocial therapies are generally considered low [56], and are probably not greater than those encountered by people with depression in their daily lives. The activities in mindfulness psychotherapy do not involve “confronting” feared objects or situations, such as in exposure therapy (e.g., where someone with a phobia of dogs must repeatedly confront dogs), or learning and practicing skills how to approach difficult situations (e.g., how to resolve arguments with one’s abusive spouse or partner). The group sessions do not require or push participants to share sensitive or traumatic information (e.g., about one’s feeling of failure; about physical abuse), and if a participant prefers not to share his or her experiences about the mindfulness activities, there is no pressure to do so. In addition, one of the rules for mindfulness groups is that participants do not comment on other participants or other participants’ comments, but rather focus directly on their own experiences with the mindfulness activities, which reduces the risk of inter-participant conflict or stress. Finally, MBCT and other mindfulness psychotherapies have a structured and gradual approach that reduces risk of overly intense experiences. So MBCT is considered to be Minimal Risk [56].

Buddhist meditation

Emotional and physical risks associated with Buddhist meditation are generally considered low. McMahan and Braun (2017) [57] reviewed scientific research on Buddhist meditation practices. They concluded that meditation is generally safe, particularly when practiced with proper guidance from trained monks or teachers, as will be the case in this project. The activities in Buddhist meditation generally do not involve sharing experiences but rather sitting in silent meditation or mantra chanting. A typical Buddhist meditation session in Vietnam would include a brief talk by the monk or leader on the meditation technique, then the meditation practice. Most practices are silent, focusing on one’s breath, although some involve chanting a mantra. After the meditation practice, there may be a short Dharma talk (a teaching on Buddhist practice and philosophy) by the monk or teacher. Participants may have the opportunity to ask questions or share their experiences, but that is entirely voluntary.

Discussion

Theoretically, Buddhist pagoda represent a useful site for task-shifting implementation of mindfulness-based interventions for depression. However, this study will have several limitations that should be considered in interpreting its findings. First, in order to reduce the risk of cross-group contamination, randomization will occur at the pagoda level, which will significantly reduce the number of randomization units. Second, also because randomization is at the pagoda level, participants and data collectors cannot be blind to condition. Third, because a “treatment as usual” condition not controlled by the project is being used, the treatment and control cond1itions will have different intervention time frames. And fourth, because of funding limitations, at present no long-term follow-up assessment is planned. Nonetheless, this study, one of the first to assess mindfulness-based interventions when implemented in Buddhist pagoda, should provide at least preliminary information regarding the potential value of pagoda as a site for mindfulness-based intervention for depression.

Data availability

No datasets were generated or analysed during the current study.

Abbreviations

EBT:

Evidence based treatment

LMIC:

Low and middle-income country

MB:

Mindfulness based

MBCT:

Mindfulness based cognitive therapy

MBCT-VN:

Mindfulness-based cognitive therapy for Vietnam

QLES-Q:

Quality of life enjoyment and satisfaction questionnaire

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Acknowledgements

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Funding

Funding for this project is being provided by the U.S. National Institutes of Health, R21 MH127563, with BW as the primary investigator. The proposal for this project was peer reviewed and approved by the U.S. National Institutes of Health, Center for Scientific Review Special Emphasis Panel# ZRG1 BDCN-N [55].

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Authors and Affiliations

  1. Department of Psychology and Human Development, Peabody College of Education and Human Development, Vanderbilt University, Nashville, Tennessee, USA

    Bahr Weiss

  2. Clinical Research Institute for Society, Psychology and Education (CRISP-E), VNU University of Education, Hanoi, Vietnam

    Van Vu & Hoang-Minh Dang

  3. Dong A University, Da Nang, Vietnam

    Lam Trung

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  2. Van Vu
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  3. Hoang-Minh Dang
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Contributions

B.W. is the primary investigator for the project with the funding agency (US NIH) and primary author of the proposal. The original design and protocol was developed as a team by B.W., V.V., H.M.D., and T.L. V.V. was responsible for leading finalization of the design, which was discussed in-depth with and approved by all authors. B.W. drafted this paper, which was finalized by all authors.

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Correspondence to Hoang-Minh Dang.

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Ethics approval and consent to participate

This study protocol was reviewed and approved by the U.S. IORG #5233 (U.S. FWA 18223; U.S. IRB6292) Committee for the Protection of Human Subjects, at the VNU University of Education – Hanoi, Vietnam, IRB Application #25004. After being informed about the study’s aims and details, potential participants will be given the opportunity to [1] provide voluntary written informed consent and join the study, or [2] decline to participate without any negative consequences.

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The authors declare no competing interests.

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Weiss, B., Vu, V., Dang, HM. et al. 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 13, 527 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s40359-025-02754-5

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BMC Psychology

ISSN: 2050-7283

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