Background: Mental health problems among workers cause enormous losses to companies in Japan. However, workers have been considered to have limited access to psychological support because of time constraints, which makes it difficult for them to engage in face-to-face psychological support interventions. Objective: This study aimed to present an intervention protocol that describes a randomized controlled trial to examine whether brief guided mindfulness meditation (MM) or self-compassion meditation (SCM) provided by a smartphone app is effective for mental health and work-related outcomes among workers. Methods: This is an open-label, 3-arm randomized controlled trial. The participants will be recruited through an open call on relevant websites with the following inclusion criteria: (1) employees who are working more than 20 hours per week, (2) between the ages of 18 and 54 years, (3) not on a leave of absence, (4) not business owners or students, and (5) not currently diagnosed with a mental disorder and have a Kessler Psychological Distress Scale-6 score below 13 points. We will include 200 participants and randomly assign them to an SCM course (n=67), an MM course (n=67), and a waitlist group (n=66). The intervention groups (SCM and MM) will be instructed to engage in daily guided self-help, self-compassion, and MMs lasting 6-12 minutes per day over 4 weeks. Primary outcomes will include psychological distress and job performance, and secondary outcomes will include somatic symptoms, cognitive flexibility, self-esteem, self-compassion, perceived stress, well-being, emotion regulation, work engagement, anger, psychological safety, and creativity. All procedures were approved by the ethics committee of the University of Tokyo (22-326). All participants will be informed of the study via the websites, and written informed consent will be collected via web-based forms. Results: The recruitment of participants began in December 2022, and the intervention began in January 2023. As of September 2023, a total of 375 participants have been enrolled. The intervention and data collection were completed in late October 2023. Conclusions: This study will contribute to the development of effective self-care intervention content that will improve mental health, work performance, and related outcomes and promote mindful and self-compassionate attitudes when faced with distress. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000049466; https://tinyurl.com/23x8m8nf
Background: Mental health problems among workers are a significant global concern, leading to substantial economic losses, particularly due to presenteeism. While mindfulness and self-compassion practices have shown promise in improving psychological well-being and occupational outcomes, traditional interventions often require a high time commitment. Low-intensity digital interventions remain underexplored, especially in the context of occupational health. Objective: This study aimed to develop and evaluate the effectiveness of a smartphone-based self-care app that enables independent practice of mindfulness and self-compassion without facilitator support. Specifically, it assessed the effects of self-compassion meditation (SCM) and mindfulness meditation (MM) on mental health and work-related outcomes among nonclinical Japanese workers. Methods: This open-label, 3-arm randomized controlled trial recruited 300 working adults in Japan, who were randomly assigned to SCM (n=101), MM (n=100), or a waitlist control group (n=99). Participants in the SCM and MM groups engaged in daily guided meditation via a custom-built smartphone app over 4 weeks. Primary outcomes included psychological distress (Kessler Psychological Distress Scale-6) and work performance (World Health Organization Health and Work Performance Questionnaire and the Stanford Presenteeism Scale), while secondary outcomes encompassed cognitive flexibility, self-compassion, perceived stress, work engagement, psychological safety, and self-perceived creativity. Assessments were conducted at baseline, postintervention (4 wk), and 1-month follow-up (8 wk). Recruitment occurred in 2 waves (November 2022-December 2022 and June 2023), with follow-up assessments completed by September 2023. Results: A total of 300 participants (mean age of 35.44, SD 9.14 y; n=180, 60% female) were randomized. Adherence was high in both intervention groups (mean completed days: SCM 23.30, SD 5.58; MM 22.95, SD 6.25), with an overall dropout rate of 21.4%. No significant group × time interactions were detected for most outcomes, although significant main effects of time were observed for several measures, including work performance and self-compassion, with small effect sizes. Within-group analyses suggested broader improvements in the SCM group, whereas changes in the MM group were more limited. In sensitivity analyses using linear mixed-effects models, a significant group × time interaction was detected for work performance, with a larger pre-post improvement in SCM. Conclusions: This low-intensity, fully self-guided, smartphone-based meditation program demonstrated good feasibility, as reflected by high adherence and relatively low attrition. Between-group effects were limited; therefore, the findings should be interpreted as preliminary and do not support strong causal claims of intervention superiority. Clinical significance remains unclear in this nonclinical sample and should be evaluated in future studies. Trial Registration: UMIN-CTR UMIN000049466; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056324 International Registered Report Identifier (IRRID): RR2-10.2196/53541