Effectiveness of on-demand acceptance and commitment training for burnout and well-being in Japanese medical students: protocol for a nationwide randomised controlled trial (BEACON Study)

Abstract

Introduction

Burnout and reduced well-being are highly prevalent among Japanese medical students during clinical training. Scalable, evidence-based interventions are urgently needed. This protocol outlines a nationwide randomised controlled trial (RCT) to evaluate a self-guided, on-demand Acceptance and Commitment Training (ACT) programme for reducing burnout and improving well-being during clinical clerkships.

Methods and analysis

This two-arm, open-label, parallel-group RCT will recruit 128 Japanese medical students in clinical clerkships, randomised to on-demand ACT or no-intervention control. The ACT intervention comprises three self-guided online modules at weeks 0, 2 and 4, plus a 30 min online booster (weeks 8–10). Self-reported outcomes are measured at baseline, mid-intervention, postintervention and at 14-week primary endpoint (week 14). The primary outcome is medical student burnout (Oldenburg Burnout Inventory for Medical Students). Secondary outcomes include well-being (Mental Health Continuum-Short Form), professional burnout (Maslach Burnout Inventory–Human Service Survey), psychological flexibility (Work-related Acceptance and Action Questionnaire, Valuing Questionnaire), depressive symptoms (Patient Health Questionnaire-9), mental illness stigma (Mental Illness: Clinicians’ Attitudes Scale version 4), ACT process knowledge (ACT Check, applied section); adverse events and serious adverse events and adherence (platform completion and engagement metrics), all assessed at prespecified time points. Data will be analysed using mixed-effects models for repeated measures on an intention-to-treat basis.

Ethics and dissemination

This protocol was approved by the Nagoya City University Clinical Research Review Board (No. 70-22-0022) and registered with the Japan Registry of Clinical Trials (jRCT1042250024). Results will be disseminated via publications and conference presentations.

Trial registration number

jRCT1042250024.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• Two-arm, open-label, randomised parallel-group design with nationwide decentralised recruitment and intervention delivery.

• Preregistered statistical analysis plan using mixed-effects models for repeated measures, assuming data are missing at random.

• Primary endpoint uses a validated burnout instrument (Oldenburg Burnout Inventory for Medical Student, week 14) with prespecified timing and analysis.

• Adherence is objectively captured via learning management system logs and analysed as a predefined process measure.

• Limitations include self-reported outcomes and the open-label design, which may introduce bias; mitigation strategies are prespecified.

Introduction

Background and rationale

Burnout among medical students has emerged as a serious global health concern. Systematic reviews and meta-analyses estimate that the prevalence of burnout in this population ranges from approximately 30% to 50% worldwide.^{1 2} Burnout is not only highly prevalent but is also associated with adverse outcomes, including depression, suicidal ideation and impaired academic performance.^{3 4} In Japan, recent university-based studies have similarly reported high rates of burnout and depression among medical students, highlighting the important roles of psychological flexibility and neurodevelopmental traits in these outcomes.^{5 6} In addition, recent systematic reviews have demonstrated that the COVID-19 pandemic has further exacerbated mental health issues, including burnout, among medical students worldwide.^{7 8}

In Japan, beyond the high prevalence of burnout and depression among medical students, unique systemic and educational factors appear to intensify these problems. Prior research has shown that even before the COVID-19 pandemic, over 85% of Japanese medical students reported low personal accomplishment. This aspect of burnout further deteriorated during the pandemic, with rates significantly higher than those reported in other countries.⁶ Several contributing factors have been identified, including institutional and legal restrictions on active clinical participation during clerkships, concerns about patient safety, supervisory demands and the structure of the national health insurance system.⁹ As a consequence, Japanese medical students typically have fewer opportunities for hands-on clinical practice, which may contribute to persistently low personal accomplishment. Additionally, since 2005, all medical graduates in Japan have been required to complete a 2-year ‘super-rotation’ residency, rotating through various specialties every one to several months. While this system was intended to broaden clinical experience, it has been criticised for potentially limiting opportunities for in-depth learning and practical experience within each specialty.¹⁰ Such systemic factors may exacerbate feelings of low personal accomplishment among both medical students and early-career doctors in Japan.

A range of interventions has been developed to address burnout and mental distress among medical students, including mindfulness-based interventions, resilience training and cognitive behavioural therapy.^11–13 Although systematic reviews indicate that mindfulness and resilience programmes can moderately reduce stress and enhance well-being in this group,^{11 14} significant challenges remain regarding the sustainability of effects, scalability and engagement, particularly in face-to-face formats.

Acceptance and Commitment Therapy (ACT) is a contemporary cognitive-behavioural approach that aims to enhance psychological flexibility—the capacity to act in alignment with personal values, even in the presence of difficult thoughts and emotions. ACT encompasses core processes such as acceptance, cognitive defusion, mindfulness, values clarification and committed action.¹⁵ ACT adapts these principles for use in educational and occupational settings^{16 17} and has demonstrated effectiveness in reducing burnout and stigma among healthcare professionals.¹⁸ Recent trials in medical education suggest that ACT and related acceptance-based approaches may improve well-being and reduce burnout and psychological distress among medical students.^{19 20} Given the specific challenges in Japanese medical education—including high rates of low personal accomplishment associated with systemic and cultural factors—psychological interventions that emphasise personal values and meaning, such as ACT, may be particularly appropriate for addressing these unique features of burnout.

Recently, several randomised trials have examined internet-based or app-based ACT interventions for medical students and healthcare workers.^20–22 Although these studies—including those conducted in China—have reported encouraging results, the evidence base for on-demand, scalable ACT interventions in medical students remains limited, and no randomised controlled trials (RCTs) have yet been conducted in Japan. While a pilot study has demonstrated the feasibility and potential benefits of face-to-face ACT for medical students during clinical clerkships in Japan,²³ the effectiveness of on-demand ACT-based interventions for burnout prevention in this context remains unknown. Further high-quality RCTs are needed to clarify the effectiveness, acceptability and implementation of on-demand ACT programmes in medical education.

To address these gaps, the present study—the trial (Burnout to Engagement through Acceptance & Commitment Training ON-demand)—aims to rigorously evaluate the effectiveness of an on-demand ACT programme in reducing burnout and improving well-being among Japanese medical students; secondary analyses will examine effects on well-being and other prespecified outcomes. To our knowledge, this is the first RCT to assess an on-demand ACT-based intervention for burnout prevention in Japanese medical students. By implementing a scalable, flexible and culturally adapted ACT programme, this study seeks to generate new evidence to inform mental health support and resilience-building strategies for medical students.

Objectives

The primary objective of this study is to determine whether a structured, digitally delivered on-demand ACT intervention reduces burnout in medical students compared with a no-intervention control group. Secondary objectives include examining effects on well-being and other prespecified outcomes (eg, psychological flexibility and depressive symptoms).

Methods and analysis

Trial design

This study is a single-centre, two-arm, parallel-group, open-label RCT. Participants will be individually randomised in a 1:1 ratio to either the intervention group or the no-intervention control group (see figure 1). The trial will be conducted in accordance with the Standard Protocol Items: Recommendations for Interventional Trials 2025 and Consolidated Standards of Reporting Trials (CONSORT) 2025 guidelines for protocol development and reporting.^{24 25}

Figure 1.

BEACON trial participant flow. This flow diagram illustrates the enrolment, allocation, intervention and follow-up process for the BEACON randomised controlled trial. After nationwide recruitment and online eligibility screening, medical students in clinical clerkship who provide informed consent undergo baseline assessment and are randomised (1:1) to either an on-demand Acceptance and Commitment Training (ACT) intervention or a no-intervention control group. Assessments are conducted at baseline, weeks 2, 4, 6 and 14. The intervention group also receives an online booster session at weeks 8–10. BEACON, Burnout to Engagement through Acceptance & Commitment Training ON-demand.

Study setting

The trial will be conducted entirely online and will be open to eligible medical students enrolled in any faculty of medicine (MD programme) in Japan. Eligible participants are fourth-year to sixth-year medical students currently undertaking clinical clerkships at their universities. All study procedures—including eligibility screening, informed consent, assessments and delivery of the intervention—will be performed online using a secure electronic data capture system. The intervention will be delivered in a digital, on-demand format.

After submitting an expression of interest via email or online form, applicants will undergo an online interview with the research office to confirm their medical student status and eligibility. Informed consent will be obtained during this interview. Participants will then provide background information online and be provisionally registered. One week later, they will be prompted to complete baseline questionnaires. Only those who complete this process and meet all eligibility criteria at week 0 will be officially enrolled. Applicants who do not provide background information, do not complete the baseline survey at week 0 or do not meet eligibility criteria at week 0 will not be enrolled.

Eligibility criteria

Inclusion criteria:

• Medical student enrolled in a Japanese faculty of medicine (MD programme) at the time of consent and registration.

• Currently engaged in clinical clerkship at the time of consent and registration.

• At registration, have moderate or greater burnout symptoms, defined as Oldenburg Burnout Inventory for Medical Students-Exhaustion (OLBI-MS) score ≥2.38 and/or OLBI-Disengagement score ≥2.25.

• Regular access to the internet and ability to participate in online interviews in a quiet and private setting.

• Sufficient understanding of the study objectives and procedures, and ability to provide voluntary informed consent.

Exclusion criteria:

• Currently receiving treatment for a psychiatric disorder in psychiatry or psychosomatic medicine and deemed unsuitable for participation by the principal investigator or coinvestigators.

• Pregnant individuals.

• Any other condition judged by the principal investigator or coinvestigators to make participation inappropriate.

All study procedures will be conducted by licensed clinical psychologists or experienced ACT trainers at Nagoya City University.

Interventions

Participants randomised to the intervention group will receive an online, self-guided ACT (on-demand ACT) programme designed for clinical-year medical students (see table 1). The programme, based on previous face-to-face research,²³ consists of three 90 min modules delivered at weeks 0, 2 and 4. Each module incorporates psychoeducation, mindfulness practices and experiential exercises grounded in ACT principles.

Table 1.

Acceptance and Commitment Training (ACT) programme overview

Time point	Format/duration	Content summary	Participant activities
Week 0 After registration	Face-to-face online meeting (~20 min)	Programme orientation Instructions for accessing on-demand videos Brief lecture: Introduction to psychological flexibility How do you respond to negative thoughts or emotions? Why do we try to control the uncontrollable? What to do when control is ineffective?	Attendance at online orientation
Week 0	On-demand video (first session) (~90 min, viewable in segments)	Introduction and practice of mindfulness and value-based behaviour Mindfulness exercises (‘raisin eating’, ‘noticing breath/body’) Clarifying values (‘80th birthday’, ‘important behaviour patterns’, ‘life compass’) Action planning based on clarified values—Introduction to ACT Matrix Preparation for next session Comprehension test	Watch video Complete comprehension test Individual practice (1–2 weeks)
Week 2	On-demand video (second session) (~90 min, viewable in segments)	Review of mindfulness/homework—‘Hook’ exercise (ACT Matrix) Setting value-based goals and actions Defusion exercises (‘Humans vs Animals’, ‘Evolution of the Mind’, ‘Paper Pushing’, ‘Good Self, Bad Self’) Acceptance exercise (‘ice-holding’) Preparation for next session Comprehension test	Watch video Complete comprehension test Individual practice (1–2 weeks)
Week 4	On-demand video (third session) (~90 min, viewable in segments)	Review of mindfulness/homework—Verbal Aikido (ACT Matrix) Metaphor: ‘Demons on a Ship’ Self-message for the future Compassion and equanimity Preparation for next session Comprehension test	Watch video Complete comprehension test Individual practice (2–4 weeks)
Week 8–10	Face-to-face online booster session (~30 min)	Review of training/homework—Q&A session	Attend booster session Individual practice (4–6 weeks)
Reminders and monitoring	Throughout programme	Reminders (via email or phone) are sent if a participant has not viewed a session within 5 days. Engagement points for participation

Participants in both intervention and control groups receive reminders for assessments.

The intervention commences with a live online orientation, where the programme schedule and procedures are outlined, followed by a 20 min lecture on psychological flexibility using materials adapted from Harris.²⁶ The first module introduces the two main pillars of the programme: (1) Mindfulness (cultivating present-moment awareness and resilience in the face of unpleasant internal experiences) and (2) Action towards values (identifying values and taking mindful, value-driven action in daily life). Participants engage in mindfulness exercises, identify values in four life domains (self-care/health/spirituality; relationships; work/study; leisure), select a domain and set a value-based goal. The ACT Matrix is introduced to support goal setting and awareness of internal barriers. Each session ends with homework assignments and a comprehension check. Homework across all modules includes practising mindfulness, pursuing value-based goals with mindful awareness of progress and obstacles, and reviewing session content. Participants are encouraged to record their observations in a diary application.

The second module begins with a review of homework focused on internal experiences encountered in pursuit of values, using the ‘Hook Exercise’ from the ACT Matrix. Participants then set a value-based goal in a different life domain. A defusion exercise follows, in which participants write their positive and negative attributes on opposite sides of a piece of paper and simply observe them, fostering awareness of the ‘observing self’. This is followed by an ‘ice-holding exercise’ to practise open observation of discomfort. Each session ends with a homework review and comprehension check.

The third module begins with a homework review using the ‘Verbal Aikido’ ACT Matrix exercise. Participants then engage in a metaphorical story activity and the ‘Send a Short Email to Future Me’ self-compassion exercise. The session concludes with a mindfulness exercise on compassion and equanimity. Participants are encouraged to continue practising these skills beyond the programme to support value-based goal attainment.

Participants are instructed to complete each module within 2 weeks of its release and to regularly practise core skills. After all modules are completed, they enter a 2-week to 4-week practice period, during which they reflect on their value-based actions and internal experiences using the ACT Matrix. The programme is delivered via a secure learning management system (LMS), which enables flexible, asynchronous access. Automated reminders and access logs will be used to promote adherence and monitor engagement.

Control group

Participants randomised to the no-intervention group will not receive any psychological intervention or additional contact during the study period. They will complete the same online assessments as the intervention group at 2, 4, 6 and 14 weeks after enrolment. Following the 14-week observation period, no-intervention group participants who wish to do so will be offered access to the on-demand ACT programme. Automated reminders for assessments and engagement will be provided to all participants to minimise attrition.

Outcomes

Primary outcome

The primary outcome is burnout, measured using the Japanese version of the OLBI-MS, which assesses two dimensions: exhaustion and disengagement.^{27 28} Both total and subscale scores will be calculated. The Japanese OLBI-MS has demonstrated reliability and validity among medical students.²⁹ The primary endpoint will be assessed at week 14 (2 months after the intervention), in accordance with the study protocol.

Eligibility for the study requires at least moderate burnout at registration, defined as a mean score of ≥2.38 on the OLBI-MS exhaustion subscale and/or ≥2.25 on the disengagement subscale. These cut-off values were derived from our previous validation study,²⁹ which used receiver operating characteristic analysis with the Maslach Burnout Inventory (MBI)–General Survey as the reference standard.^{30 31} The optimal thresholds were determined using the Youden index to maximise sensitivity and specificity for moderate burnout, yielding a cut-off of 2.38 for exhaustion (AUC=0.85, sensitivity=0.85, specificity=0.73) and 2.25 for disengagement (AUC=0.81, sensitivity=0.63, specificity=0.82).

Secondary outcomes

Secondary outcomes include a range of psychological, behavioural and functional measures, each assessed at five time points (weeks 0, 2, 4, 6 and 14), unless stated otherwise:

• Burnout among helping professionals: MBI–Human Service Survey, measuring emotional exhaustion, depersonalisation and personal accomplishment.^{30 32}

• Well-being: Mental Health Continuum–Short Form (Japanese version), assessing emotional, social and psychological well-being.^{33 34}

• Depressive symptoms: Patient Health Questionnaire-9, a validated screening and severity instrument for depression.^{35 36}

• Valued living: Valuing Questionnaire (Japanese version), evaluating values-based action and psychological flexibility.^{37 38}

• Work-related psychological flexibility: Work-related Acceptance and Action Questionnaire (Japanese version), measuring psychological flexibility in work contexts.^{39 40}

• Stigma towards mental illness: Mental Illness: Clinicians’ Attitudes Scale version 4 (Japanese version).^41–43

• ACT knowledge: ACT Check (applied section only), a Japanese measure of psychological flexibility process knowledge.⁴⁴

• Adverse events (AEs): Monitoring of serious AEs (SAEs), AEs and withdrawal reasons throughout the trial in accordance with CONSORT guidance.²⁵

• Adherence: Assessed via LMS logs of module completion, number of logins and platform engagement.

Background variables

At baseline, demographic and background information will be collected: age, gender, preferred specialty (categorised as in prior literature), living situation, marital status, children, part-time job, club activity, enrolment in other programmes, alcohol use, psychiatric history, current psychotropic medication and prior ACT experience.⁴⁵ Autistic traits will be assessed using the Autism Spectrum Quotient–Japanese 21 (AQ-J-21)^{46 47} and ADHD traits by the Adult ADHD Self-Report Scale, 6-item version (ASRS-J-6; Japanese version).^{48 49}

Table 2 summarises the assessment schedule. Online supplemental table S1 provides full definitions, instruments and timing for each outcome measure.

Table 2.

Assessment schedule and measurement time points for outcomes and background variables in the BEACON Trial

Measurement	Aim	Prebaseline	Week 0 (Baseline)	Week 2	Week 4	Week 6	Week 14 (follow-up)
Informed consent		X
Eligibility assessment		X
Background variables
Demographic data		X
AQ-J-21		X
ASRS-J-6		X
Primary outcome
OLBI-MS	Burnout (medical students)		X	X	X	X	X
Secondary outcomes
MBI-HSS	Burnout (helping professions)		X	X	X	X	X
MHC-SF	Well-being		X	X	X	X	X
PHQ-9	Depressive symptoms		X	X	X	X	X
VQ	Valued living (psychological flexibility)		X	X	X	X	X
WAAQ	Work-related psychological flexibility		X	X	X	X	X
MICA-4	Stigma toward mental illness		X	X	X	X	X
ACT Check	ACT knowledge	X					X

ACT Check, Acceptance and Commitment Therapy Check; AQ-J-21, Autism Spectrum Quotient–Japanese 21; ASRS-J-6, Adult ADHD Self-Report Scale Japanese 6; BEACON, Burnout to Engagement through Acceptance & Commitment Training ON-demand; MBI-HSS, Maslach Burnout Inventory–Human Service Survey; MHC-SF, Mental Health Continuum–Short Form; MICA-4, Mental Illness: Clinicians’ Attitudes Scale version 4; OLBI-MS, Oldenburg Burnout Inventory for Medical Students; PHQ-9, Patient Health Questionnaire-9; VQ, Valuing Questionnaire; WAAQ, Work-related Acceptance and Action Questionnaire.

Sample size

A priori power analysis (G*Power V.3.1) was performed to estimate the required sample size for the primary outcome (burnout reduction at week 14). Based on prior ACT intervention studies in healthcare populations,^{20 22 23} a moderate effect size (Cohen’s d=0.5), significance level of 0.05 (two-tailed) and 80% power were assumed. The design included a repeated measures within-between interaction (two groups×five time points: weeks 0, 2, 4, 6, 14). This yielded a required sample size of 128 participants (64 per group). The calculation included an anticipated 20% dropout rate, based on similar digital mental health trials.⁵⁰ As repeated measures mixed-effects models (mixed-effects models for repeated measures, MMRM) provide equivalent statistical power with smaller sample sizes compared with cross-sectional analyses, the chosen sample size is considered sufficient even with attrition.⁵¹

Recruitment

Recruitment will target fourth-year to sixth-year medical students undertaking clinical clerkships in Japan. Study invitations will be disseminated nationally via university mailing lists, internal portals, bulletin boards, professional organisations, flyers and the official study website. Interested students will contact the research team by email or online form. Eligibility will be confirmed in an online interview, followed by electronic informed consent. Applicants will then submit background information and be provisionally registered. After 1 week, they will complete baseline questionnaires; only those meeting all eligibility criteria at week 0 will be officially enrolled. Recruitment will continue on a rolling basis until the target sample size is reached. To minimise attrition, participants will receive reminders at each assessment, and no-intervention group participants will be offered the intervention after study completion if they wish.

Allocation and blinding

Participants will be randomly allocated to the intervention or control group in a 1:1 ratio, using a computer-generated minimisation method with random elements to ensure balanced groups. Allocation will be stratified by gender (male, female or other) to address potential gender-related differences in burnout and intervention response. The trial is open-label, as blinding of participants and researchers is not feasible due to the nature of the psychological intervention and use of self-report measures. Statistical analyses will be performed by an independent analyst who is blinded to group allocation. The allocation sequence will be generated and maintained by an independent data manager not involved in participant recruitment or assessment.

Data collection and management

All assessments will be completed via secure online questionnaires, administered through a password-protected electronic data capture system. Participants will be identified by anonymous study IDs. Survey completion will be tracked through system logs to monitor adherence and completion rates. All data will be encrypted and stored on secure university servers with access restricted to principal investigators and authorised research staff. Data quality will be maintained through range checks, automated logic checks and manual review of missing or inconsistent data. Personally identifiable information will be stored separately from study data and linkage will be maintained only for the duration of the trial.

Statistical methods

All analyses will be performed using R (V.4.4.1) or equivalent statistical software. The primary analysis will follow the intention-to-treat principle, including all participants as randomised. The primary endpoint is the OLBI-MS score at week 14. MMRM will be used, including fixed effects for group (intervention vs control), time (weeks 0, 2, 4, 6 and 14), group×time interaction and random intercepts for participants. Baseline scores will be included as covariates. Pre–post effect sizes (Cohen’s d) will be calculated as the estimated change from baseline to week 14 divided by the baseline SD. A per-protocol set or completer analysis will also be conducted, with completers defined as participants who complete all modules and the booster session. No interim analyses are planned. Subgroup analyses will be performed for baseline burnout severity, autistic traits (AQ-J-21≥12), Attention Deficit Hyperactivity Disorder (ADHD) traits (ASRS-J-6 ≥15), previous university graduation and preferred speciality. Missing data will be assumed to be missing at random and handled within the mixed-model framework. Sensitivity analyses using multiple imputation will be performed as appropriate. AEs and adherence will be monitored and summarised descriptively.

Patient and public involvement

No patients or members of the public were involved in the design, development or conduct of this study. This approach was determined by the specific context of the trial population (medical students) and limitations in available resources and timeframe. However, qualitative feedback from preliminary student interviews was used to inform the intervention content.

Monitoring and trial oversight

Given the low-risk and non-invasive nature of the psychological intervention, a formal data monitoring committee will not be established. Instead, trial conduct and data integrity will be monitored internally by the principal investigators, with oversight from the Clinical Research Management Office at Nagoya City University.

The study may be paused or terminated early in the following situations:

• If 50% or more of enrolled participants withdraw before completing the postintervention assessment (week 6).

• If an SAE related to the intervention is reported and deemed intervention-related by the ethics committee.

• If unanticipated ethical concerns arise regarding participant burden or data handling.

In these cases, the principal investigator will consult the ethics committee and institutional authorities before making a final decision.

Ethics and dissemination

Research ethics approval

The study was approved by the Nagoya City University Clinical Research Review Board (approval number: 70-22-0022, 27 March 2023) and is registered in the Japan Registry of Clinical Trials (jRCT1042250024). Any significant protocol modifications will be communicated to the review board, investigators, trial registry and, where appropriate, trial participants.

Informed consent

Participants will receive comprehensive written and verbal information online, including study aims, procedures, risks, benefits and confidentiality. Electronic informed consent will be obtained before any data collection using a secure online system. Participation in this study is entirely voluntary, and students may withdraw at any time without penalty. Participation or non-participation will have no effect on academic standing, grades, progression or graduation. No ancillary studies involving additional data or biological specimens are planned. No specific post-trial care or compensation is planned. A model consent form is provided in online supplemental file 1.

Confidentiality

All data will be stored on secure university servers in encrypted, password-protected formats. Participant data will be anonymised using study IDs, and identifiable information will be stored separately. Only authorised research staff will have access to linkage files.

Dissemination policy

Study results will be disseminated through presentations at national and international conferences and published in peer-reviewed open access journals. Authorship will follow ICMJE guidelines. No professional writers will be used.

Protocol availability and data access

The full trial protocol and statistical analysis plan will be made available via the Japan Registry of Clinical Trials (https://jrct.mhlw.go.jp).

Trial registration

The trial has been prospectively registered in the Japan Registry of Clinical Trials (jRCT1042250024), registered on 18 May 2025. All items from the WHO Trial Registration Data Set are included in the registry entry. https://jrct.mhlw.go.jp/latest-detail/jRCT1042250024

Ethics statements

Patient consent for publication

Consent obtained directly from patient(s).