Mindfulness-based programs (MBPs) are defined as interventions featuring systematic and sustained training in formal and informal mindfulness meditation practices; this training is recognized as central to both the therapeutic approach and the underpinning theoretical model [1]. Numerous clinical trials have demonstrated the effectiveness of MBPs in clinical populations, including patients with depression [2-4], anxiety [5-11], cancer [12-15], and pain [16-20]. These results have been affirmed by the findings of several meta-analyses [21-25].

However, it should be noted that the effectiveness of MBPs is not restricted to clinical populations. MBPs have been shown to be effective in nonclinical populations as well. Existing evidence indicates that MBPs are efficacious for the improvement of stress, sleep, quality of life, and subjective well-being in healthy individuals [26-38]. This is also applicable in the context of occupational health. In their latest meta-analysis of 23 randomized controlled trials (RCTs), Bartlett et al [39] endorsed the effectiveness of MBPs in the workplace for the improvement of numerous clinical factors, such as perceived stress, psychological distress, depression, anxiety, burnout, well-being, and sleep.

Regarding productivity, which is of most interest to managers, Bartlett et al [39] concluded that productivity was assessed too inconsistently and infrequently for related results to be included in their meta-analysis; thus, they reported the results narratively. Three previous studies have indicated that absenteeism and presenteeism post-MBP intervention show a positive but nonsignificant tendency [35,40,41]; however, one study indicated no effect in that regard [42,43]. Regarding work engagement, although 1 study showed null results [42,43], another study revealed a significant positive effect of MBPs on work engagement [44]. As the inconsistency of the results of previous studies indicates, the effect of MBPs on productivity in the workplace is still unclear. In addition, certain aspects of MBPs, including the delivery mode (eg, online delivery) and the number of sessions, tend to be modified when applied in the workplace to improve accessibility. These modifications are likely to be applied more frequently because of the effects of the COVID-19 pandemic. However, in 85% of the studies included in the meta-analysis by Bartlett et al [39], the interventions were delivered face-to-face and the average number of sessions offered was not necessarily small (7). Thus, the effectiveness of MBPs delivered online and in a small number of sessions for improved accessibility has not been sufficiently investigated, especially in terms of productivity in the workplace.

Therefore, we developed a brief mindfulness-based cognitive therapy (bMBCT) program, which consists of four 1.5-hour sessions, to evaluate the effectiveness and cost-effectiveness of online bMBCT for the improvement of productivity and other work-related indicators compared to the waitlist control.

The aim of this study is to investigate the effectiveness and cost-effectiveness of online bMBCT for the improvement of productivity and other work-related outcomes among healthy workers compared to the waitlist control.

We started recruiting participants in August 2021. The intervention is ongoing and is scheduled to be completed in December 2023. The study is being conducted at the Keio University Center for Stress Research in Tokyo, Japan. The participants are being recruited from among the employees of 3 companies in different industries: Daiwa Securities Group Inc (security), Kumon Institute of Education Co, Ltd (education), and Nichirei Corporation (processed foods). Participants are eligible for the study if they meet the following criteria: (1) aged between 20 and 65 years, (2) work longer than 30 hours weekly, (3) have no history of sick leaves longer than 1 month due to mental disorders or have recovered for longer than 6 months after a sick leave, (4) have physical illnesses but are judged fit to participate in the research by the investigators, (5) score 8 or less in the absolute presenteeism item of the World Health Organization Health and Work Performance Questionnaire (WHO-HPQ), (6) can participate in the intervention and respond to the questionnaires via the internet, and (7) can provide written informed consent. Eligible participants are excluded if they (1) have previously participated in a mindfulness-based intervention for 8 weeks or longer, (2) are unlikely to participate during the research period (eg, they plan to move/relocate), and (3) are judged by the investigators as unfit to participate in the intervention due to physical conditions and other reasons (eg, unstable internet connection). Candidates who score higher than 8 on the WHO-HPQ absolute presenteeism item are allowed to participate in the intervention but will not be included in the RCT. The obtained data will be included in the multivariable analysis described later.

Prospective participants, who applied for the study via recruiting announcements delivered at each company, received a link to the web screening from the research cooperator at each company. If they passed the web screening, an announcement of the video group orientation was made. In the online group orientation, the research investigators provided written and oral explanations of the study, which included full descriptions of the purpose, significance, and methods of the study; the risks and benefits of participation; and the requirements for consent. Prospective participants were also offered an opportunity to ask questions. The investigators recorded the method, content, and date of the explanations provided. After the online group orientation, individual video interviews were held and the research investigator evaluated whether the participants met the inclusion criteria. Since obtaining written informed consent via online sessions was not feasible, all included participants provided informed consent verbally. The records were converted into PDF files, saved in an electronic storage medium, and stored in a lockable cabinet at the Stress Research Center.

The included participants completed the questionnaires administered for the collection of demographic and psychosocial data. The psychological assessment tools to be utilized include the WHO-HPQ, the Five Facet Mindfulness Questionnaire (FFMQ), the 9-item Utrecht Work Engagement Scale (UWES-9), the Satisfaction With Life Scale (SWLS), the Flourishing Scale (FS), the Scale of Positive and Negative Experience (SPANE), the Experiences Questionnaire (EQ), the Perceived Stress Scale (PSS), the Investigating Choice Experiments Capability Measure for Adults (ICECAP-A), Team Psychological Safety (TPS), and the Credibility/Expectancy Questionnaire (CEQ). The details of each scale are presented later in the Instruments section.

Eligible participants were randomly allocated to either the bMBCT or the waitlist control group (in a 1:1 ratio). The participants were assigned a computer-generated random number stratified according to company and the baseline WHO-HPQ absolute presenteeism score. The Project Management Office at the Keio Center of Clinical Research, which is an institution independent from the study group, managed the randomization process. The flow of participant recruitment is shown in Figure 1.

Due to the nature of psychological interventions, both the participants and the therapists were not blinded to randomization statuses. Since all measurements obtained during the study are self-reported, there were no assessors for the evaluation of the statuses of participants.

Participants in the control group will wait until the intervention group has completed the intervention. During this waiting period, they have been requested not to attend other mindfulness or meditation activities. After the waiting period is completed (ie, 7 months after allocation), the participants in the control group will be offered the same bMBCT but without monthly follow-up sessions.

Cost-effectiveness was measured by calculating the incremental cost-effectiveness ratio, which is the incremental cost divided by the incremental effectiveness between the groups. Incremental effectiveness was evaluated using quality-adjusted life-years, calculated from the weighted ICECAP-A scores. The analyses were conducted from a company’s perspective (ie, direct cost). Cost benefit will be evaluated using the net monetary benefit, which is calculated by subtracting the incremental cost needed for the intervention from the net monetary benefit of incremental productivity, weighted by the WHO-HPQ score.

Daily formal meditation time and the answers to open-ended questions are collected at the end of each session. The questions include the following: (1) What did you notice in this session? (2) Did you experience any difficulties in this session? (3) Do you have any comments to improve the sessions?

The validity and reliability of the original versions of all these scales have been confirmed [46-56]. Regarding the Japanese versions of the scales, the validity and reliability of all scales and questionnaires, except ICECAP, the TPS, and the CEQ, have been confirmed [57-62]. For ICECAP-A, the Japanese version of the ICECAP officially accepted by the University of Birmingham was used [63]. We adopted the Japanese version of the CEQ, which was translated by Ito et al [64] through a rigorous back-translation procedure with the permission and support of the original developer of the questionnaire. Regarding the TPS, we used the TPS questionnaire cited in the Japanese edition of The Fearless Organization: Creating Psychological Safety in the Workplace for Learning, Innovation, and Growth by Edmondson [65].

In addition to the baseline assessment, we requested that the participants respond to these self-report assessments at 4 weeks, 3 months, and 6 months postintervention. A range of ±2 weeks from the scheduled dates for the baseline and postintervention assessments and ±4 weeks for the 3- and 6-month postintervention assessments were allowed. All assessment data were collected using the electronic patient-reported outcomes (ePRO) system. The assessment schedules are presented in Tables 2 and 3.

The primary outcome will be analyzed using the mixed model repeated measurement (MMRM) method to compare the amount of change between groups before and after the intervention (α .05, β .10). To the best of our knowledge, no previous studies have indicated the effect size of MBPs on presenteeism among employees. The sample size was calculated based on the results of a study that showed the effect of MBPs on the quality of life (effect size=0.44) [37]. We estimated that a total of 166 participants are required; however, the sample size was set at a maximum of 220 participants, considering the dropout rate (assumed to be 25%). The dropout rate was referred to the study of an online MBP in the workplace by Aikens et al [44], which reported the dropout rate was 23%.

Statistical analyses and reporting of this trial will be based on the intention-to-treat approach. Analyses with complete samples will be also performed to verify the robustness of the results.

The full analysis data set will include all randomized subjects who underwent at least 1 procedure of the intervention.

For baseline variables, we will generate summary statistics with proportions and frequencies for categorical variables and means and SDs for continuous data. For primary and secondary outcome analyses, we will analyze the mean changes from baseline using the MMRM method. Analyses conducted using the MMRM method will include the fixed and categorical effects of intervention, time, and the intervention × time interaction. Imputation will not be performed for missing values, because mixed models can deal with missing data through the maximum likelihood. All comparisons are planned, and all P values will be 2-sided. The significance level will be set at 5% for all statistical analyses. All analyses will be conducted using Stata version 16 (StataCorp).

We will also conduct a multivariate analysis to verify the predictors and mediators of the primary and secondary outcomes. A detailed analytical plan will be presented separately.

The research team will immediately contact the Ethics Review Committee at the Keio University School of Medicine if the participants report any serious adverse events. Serious adverse events are defined as follows: (1) death by suicide, (2) death by nonsuicide, (3) a suicide attempt (self-injurious behavior that admits a suicide attempt), (4) an event that may lead to death, (5) psychiatric hospitalization, (6) general hospitalization due to an adverse event, (7) disability leading to inactivity due to an adverse event, or (8) any events judged to be medically serious based on the Japanese version of Common Terminology Criteria for Adverse Events v3.0 by the Japan Clinical Oncology Group/the Japan Society of Clinical Oncology [66]. Participants are asked to report any adverse events at the end of each session.

The authors confirmed that all procedures complied with the ethical standards of the relevant national and institutional committees on human experimentation and with the tenets of the 1975 Declaration of Helsinki, revised in 2008. All procedures involving human participants and patients were approved by the Ethics Review Committee of the Keio University School of Medicine (Reference 2021-0101). All included participants provided informed consent after all procedures were explained in detail. They were allowed to withdraw their consent at any time without any negative consequences.

We expect the results of our research to be presented at conferences and published as papers in academic journals. The results of this research will adhere to the Consolidated Standards of Reporting Trials (CONSORT) statement.

The aim of this study is to evaluate the effectiveness and cost-effectiveness of bMBCT in the workplace, especially for productivity. This study is valuable because it will fill certain gaps in the existing MBCT research. First, previous studies have revealed that the effectiveness of MBPs for physical and psychological indicators (eg, stress, burnout, and sleep well-being,) is promising; however, its effects on productivity are still unclear. This study is expected to clarify this important aspect of the use of MBPs in the workplace. Second, as the participants of this study are being recruited from 3 companies in different industries (security, education, and processed foods), the generalizability of the study findings will be enhanced because the cohorts of previous studies were recruited from a single company. Third, this study will focus on the evaluation of the effectiveness of online bMBCT in the workplace. Since the accumulated evidence on the effect of online bMBCT is still insufficient, the results of this study will advance the understanding of the use and effect of online bMBCT in the workplace. This is particularly important in the current scenario where many employees are forced to work from home. Furthermore, we will compare the effectiveness of bMBCT with follow-up and bMBCT without follow-up. The participants in the waitlist control group will receive bMBCT without follow-up once the waiting period is completed. Although this is not a direct RCT-based comparison, we can preliminarily evaluate the differences between the effect of bMBCT with and bMBCT without follow-up. Finally, we included a scale for the assessment of an organization’s culture. Although previous studies have revealed that an individual’s productivity is affected by individual factors and their organization’s culture, such as team psychological safety, the interaction between individual and organizational factors has not been assessed to date. In the multivariate analysis, we plan to investigate the effect of differences in an organization’s culture on the study outcomes. We are aware that focusing on productivity may possibly induce the increase of the “craving mind” of the participants, which is contrary to the purpose of MBPs. Such misuse of MBPs could have a negative impact on employees’ health and well-being. Therefore, we will also assess these outcomes as well as productivity in order to evaluate the suitability of our MBP.

This study has the following limitations. First, as all measures assessed are in self-report format, uncertainty regarding objectivity remains. Second, since we do not have an active control group (we set the waitlist as the control group), we cannot detect the effects that are specifically attributable to bMBCT. However, considering that the main objective of this study is to investigate the effectiveness of augmenting typical daily life with bMBCT rather than to assess the efficacy of bMBCT, we considered the research design to be acceptable for that purpose. Third, although we encourage the participants to report any serious adverse events at the end of each session, we will not assess mild-to-moderate adverse events. Therefore, the adverse events caused by this intervention might be underestimated. Despite the aforementioned limitations, we believe that this study will provide valuable information for future clinical trials in this field.

This study has the potential to provide new data on the relationship between MBPs and occupational health and productivity.