Implementation of an internet-based stress management program in micro- and small-sized enterprises: a study protocol for a pre-post feasibility study of the effectiveness-implementation hybrid type 2 trial.

BACKGROUND: Although internet-based stress management programs are proven effective in improving mental health among workers, micro- and small-sized enterprises (MSEs), lacking in occupational healthcare services, face challenges implementing them. To address this gap, this study will develop the program with stakeholders at MSEs to aim for real-world implementation. OBJECTIVES: This paper describes a study protocol for a pre-post feasibility study of an effectiveness-implementation hybrid type 2 trial of text-based internet-based programs ("WellBe-LINE") in MSEs with less than 50 employees. This feasibility study primarily aims to evaluate trial methods for future effectiveness-implementation hybrid type 2 trials. METHODS: For this study protocol, an internet- and text-based self-care intervention program using the LINE app (a popular message tool in Japan) will be prepared according to evidence-based psychoeducational topics. Based on our online survey findings, personalized algorithms will be implemented according to employees' gender, age, and psychological distress levels. A personalized program using a popular pre-existing text app is expected to reduce employees' burdens and be attractive to them, resulting in successful implementation outcomes and mental health benefits. A pre-post design feasibility study will be conducted on ten companies to evaluate trial methods (e.g., recruitment and procedures). The primary outcome will involve individual-level penetration, defined as the proportion of the number of employees who register for the program divided by the total number of invited employees at the company. The progression criterion to go next trial specifies that more than 50% of the recruited companies obtain 60% individual penetration, which is set based on the findings of the prior survey of employees at MSEs and of interviews of stakeholders involved in this study, and will be measured by LINE system. Finally, acceptability, appropriateness, and feasibility will be measured using internet-based questionnaires and interviews. DISCUSSION: This pre-post feasibility study for future effectiveness-implementation hybrid type 2 trials will provide in-depth knowledge about the successful implementation of text-based, semi-personalized, self-care mental health interventions in real-world settings using both quantitative and qualitative data. CONCLUSIONS: This feasibility study will help validate the effectiveness of text-based interventions using a widely used social networking service (SNS) tool for employees in MSEs. TRIAL REGISTRATION: UMIN clinical trial registration, UMIN000046960. Registered on February 21, 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053570.

Loneliness without distress, chosen isolation (solitude) at the workplace, and mental health and job performance: a cross-sectional study of Japanese employees.

While loneliness and social isolation in the workplace affect the mental health and job performance of employees, the effects of loneliness without distress and solitude (i.e., chosen isolation) on these outcomes are unclear. The cross-sectional association was examined by using online survey of full-time employees in Japan (n=846). The results showed that the "loneliness with distress" group had significantly higher psychological distress and lower job performance than the other groups. Work engagement was lower both in the "loneliness with distress" and "loneliness without distress" groups, compared to the "non-loneliness" group. The "unchosen isolation" and the "solitude" groups had poorer scores of psychological distress, work engagement, and work performance, compared to the "non-isolation" group. The preliminary findings showed that loneliness without distress and solitude were associated with poor levels of mental health and job performance and should become a target of mental health promotion interventions in the workplace.

Euthymia scale as a protective factor for depressive symptoms: a one-year follow-up longitudinal study.

OBJECTIVES: This study aimed to examine whether a high score on the euthymia scale (ES) predicts a low incidence of depressive symptoms one year later. METHODS: The baseline online survey was conducted in February 2020, and a follow-up survey was done in February 2021. Japanese over 20 years old were enrolled. Respondents who answered both baseline and follow-up, and without depressive symptoms at baseline were included in the analysis. The euthymia scores at baseline was measured by the 10 items of the Japanese version of the ES. Depressive symptoms at follow-up were determined if participants showed either depressive feelings or anhedonia. The odds ratio (OR) was calculated using multivariate logistic regression analysis, adjusting for age, gender, marital status, educational attainment, and clinical visit for depressive episode before the baseline survey. RESULTS: The total of 624 participants were analyzed. A total of n = 63 (10.1%) presented depressive symptom at follow-up. A high ES score significantly predicted a lower incidence of depressive symptoms, after adjusting for covariates (aOR = 0.81 [95% confidence interval: 0.72-0.89]). Using the cutoff score retrieved from this data, a high ES score (7 or more) showed the same tendency, compared to a low ES score (< 7) (aOR = 0.46 [0.25-0.83]). CONCLUSIONS: This study suggests the predictive usefulness of euthymia for subsequent depressive symptoms. Further investigation is needed by employing rigid diagnostic criteria.

Reliability and validity of the Japanese version of the Professional Fulfillment Index among healthcare professionals: A validation study.

OBJECTIVES: Translation of the Professional Fulfillment Index (PFI) into Japanese would be more useful than the currently developed scales for appropriately measuring burnout and professional fulfillment in healthcare professionals. This study aimed to develop the Japanese version of the PFI and examine its internal consistency, structural validity, and convergent validity in healthcare professionals. METHODS: Healthcare professionals in Japan were recruited online. The survey was conducted from October to November 2022. Internal consistency was tested using Cronbach's α. Structural validity was tested using confirmatory factor analysis (CFA) and exploratory factor analysis (EFA). Convergent validity was tested using Pearson's correlation coefficients, which were calculated between each score of the PFI scale and burnout (the Japanese Burnout Scale: JBS), depressive symptoms (the Patient Health Questionnaire-9), and QOL (the General Health Questionnaire-12). RESULTS: The Cronbach's alpha was .91 in professional fulfillment, .80 in burnout: work exhaustion, .90 in burnout: interpersonal disengagement, and .89 in burnout: total score. Confirmatory factor analysis demonstrated a modest fit, and EFA yielded a three-factor structure the same as the original PFI. The all three subscales and total score of burnout were significantly correlated with the scores of all the scales (p < .001; e.g., burnout: work exhaustion correlated emotional exhaustion in JBS, r = .71). CONCLUSIONS: The Japanese version of the PFI demonstrated acceptable high internal consistency, structural validity, and convergent validity of the scale with a three-factor structure the same as in the original PFI. The Japanese version of PFI proved to be reliable and valid for use in healthcare professionals.

Adverse childhood experiences and living in the socially deprived areas in adulthood: a cross-sectional study of the nationwide data in Japan.

OBJECTIVES: This study aimed to examine whether having adverse childhood experiences (ACEs) was associated with living in a deprived area in adulthood. METHODS: The cross-sectional study was conducted by using nation-wide data in 2022 of the Japan COVID-19 and Society Internet Survey (JACSIS). Participants were community dwelling people 18 years or older. ACEs were assessed by Japanese version of 15-items ACE measurement tool (ACE-J). Living condition was measured by Area Deprived Index (ADI) and Densely Inhabited District (DID) based on zip code. Multivariable logistic regression to analyze the associations between ADI and ACE 4 + was conducted, controlling for individual-level factors, such as age, sex, marital status, and education, as an additional analysis. RESULTS: The total of 27,916 participants were included in the analysis. The prevalence of emotional neglect, childhood poverty, and school bullying were 38.2%, 26.5%, 20.8%, respectively. 75% of the population had one or more ACE(s). The number of ACEs was associated with significantly higher risk of living in deprived area in the adulthood (p = 0.001). ACEs were not associated with living in density area. The association between ADI and ACEs 4 + was non-significant after controlling the individual-level factors. CONCLUSION: People with higher number of ACEs tend to live in deprived areas in adulthood. Policy makers in highly deprived areas can apply the trauma-informed approach for the community care and support, which is critical to mitigating deficit perspectives and facilitating comprehensive support for those with ACEs.

Effects of an Internet Delivered Behavioral Activation Program on Improving Work Engagement Among Japanese Workers: A Pretest and Posttest Study.

OBJECTIVE: The aim of the study is to examine the effect of a newly developed Internet-delivered behavioral activation (iBA) program on work engagement and well-being among Japanese workers with elevated psychological distress. METHODS: Participants were recruited via an Internet survey company ( N = 3299). The eligibility criteria were as follows: (1) Japanese employees aged 20 to 59 years, (2) having psychological distress, and (3) not self-employed. This iBA program was a 3-week web-based training course using behavioral activation techniques. Work engagement, psychological distress, and eudemonic well-being at work were measured at baseline and postintervention period. A paired sample t test was conducted to assess the intervention effect. RESULTS: Of the 568 eligible participants, 120 were randomly selected. A total of 108 participants completed the baseline survey and received the iBA program. Eighty respondents completed the postintervention survey and were included in analyses. The iBA program did not show a significant intervention effect on work engagement ( P = 0.22, Cohen d = 0.14), while psychological distress ( P < 0.01, d = -0.40) and role-oriented future prospects ( P = 0.02, Cohen d = 0.27) were significantly improved. CONCLUSIONS: The effect of the iBA program on work engagement may be limited.

Corrigendum: What kind of intervention is effective for improving subjective well-being among workers? A systematic review and meta-analysis of randomized controlled trials.

[This corrects the article DOI: 10.3389/fpsyg.2020.528656.].

Working environment at home and mental health in employees working from home in Japan during COVID-19 pandemic: A cross-sectional study.

OBJECTIVES: This cross-sectional study aimed to examine the associations of a poor working environment at home with psychological distress and psychosomatic symptoms in employees working from home in Japan during the COVID-19 pandemic. METHODS: The data obtained in October 2021 from an online cohort of full-time employees (E- COCO- J) were used. Participants who worked from home for at least some days per month were included. The poor working environment at home was assessed using 11 items based on the Japanese Ministry of Health, Labour and Welfare recommended checklist. The score ranged from 0 to 11. Psychological distress and psychosomatic symptoms were measured by the Brief Job Stress Questionnaire (BJSQ). The associations between total scores of poor working environment and outcomes were examined by multiple regression analysis, adjusted by age, sex, education, living with family, frequencies of working from home, company size, job demand, job control, and workplace social support. RESULTS: Two hundred twenty-six employees who were working at home were included. The mean of the summed scores of poor working environments at home was 2.75. After adjusting the covariates, summed scores of poor working environments were significantly associated with high psychological distress (standardized ß = 0.21, P = .003) and with high psychosomatic symptoms (ß = 0.19, P = .005). For each poor environment, lack of ventilation and difficulty staying hydrated or resting were significantly associated with both outcomes. CONCLUSIONS: Even after adjusting for job stressors and support, working environments at home were associated with employees' mental health. Appropriate measures and education may be needed.

Work-related psychosocial factors and inflammatory markers: A systematic review and meta-analysis.

OBJECTIVE: We conducted a systematic review and meta-analysis to evaluate the prospective effect of adverse work-related psychosocial factors on increases in inflammatory markers. METHODS: A systematic literature search was conducted in PubMed, Embase, PsycINFO, PsycARTICLES, and the Japan Medical Abstracts Society database. Studies were eligible for inclusion if they examined associations between work-related psychosocial factors and inflammatory markers (interleukin-6, tumor necrosis factor-alpha, and C-reactive protein), used longitudinal or prospective cohort designs, were conducted among workers, were original articles written in English or Japanese, and were published up to 2017 for the first search, October 2020 for the second, and November 2022 for the third. A meta-analysis was conducted using a random-effects model to assess the pooled effect size for the associations. A meta-regression analysis was used to estimate the association between length of follow-up and effect size. The ROBINS-I tool was used to assess risk of bias. RESULTS: Of the 11,121 studies identified in the first search, 29,135 studies from the second, and 9448 studies from the third, eleven were eligible for this review and meta-analysis. The pooled coefficient between adverse work-related psychosocial factors and inflammatory markers was significant and positive (ß = 0.014, 95% confidence interval: 0.005-0.023). However, a clear association was only observed for interleukin-6, and all the studies included had serious risks of bias. Meta-regression showed the effect size decreased depending on the follow-up period. CONCLUSION: This study revealed a weak positive association between adverse work-related psychosocial factors and increases in inflammatory markers. TRIAL REGISTRATION: PROSPERO CRD42018081553 (https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=81553).

Effects of work-family life support program on the work-family interface and mental health among Japanese dual-earner couples with a preschool child: A randomized controlled trial.

OBJECTIVES: This study examined the effectiveness of a newly developed work-family life support program on the work-family interface and mental health indicators among Japanese dual-earner couples with a preschool child(/ren) using a randomized controlled trial with a waitlist. METHODS: Participants who met the inclusion criteria were randomly allocated to the intervention or the control groups (n = 79 and n = 85, respectively). The program comprised two 3-h sessions with a 1-month interval between them and provided comprehensive skills by including self-management, couple management, and parenting management components. The program sessions were conducted on weekends in a community center room with 3-10 participants. Outcomes were assessed at baseline, 1-month, and 3-month follow-ups. Primary outcomes were work-family balance self-efficacy (WFBSE), four types of work-family spillovers (i.e., work-to-family conflict, family-to-work conflict, work-to-family facilitation, and family-to-work facilitation), psychological distress, and work engagement reported by the participants. RESULTS: The program had significantly pooled intervention effects on WFBSE (P = .031) and psychological distress (P = .014). The effect sizes (Cohen's d) were small, with values of 0.22 at the 1-month follow-up and 0.24 at the 3-month follow-up for WFBSE, and -0.36 at the 3-month follow-up for psychological distress. However, the program had nonsignificant pooled effects on four types of work-family spillovers and work engagement. CONCLUSIONS: The program effectively increased WFBSE and decreased psychological distress among Japanese dual-earner couples with a preschool child(/ren).

A proposed definition of participatory organizational interventions.

Participatory organizational interventions offer an effective way to promote occupational safety and health. Despite an increasing number of studies, a common definition of participatory organizational interventions has yet to be established. Therefore, we aimed to form a definition using the following process. First, we developed a tentative draft definition of organizational interventions and participatory elements, based on the relevant literature. The tentative definition was revised in several rounds of an extensive discussion by the authors. This resulted in the draft definition. We asked 15 selected international experts in occupational safety and health to review and comment on the draft definition. We carefully reviewed their comments, and formulated our final proposed definition. To summarize the key points of the final version of the definition, organizational interventions are planned actions that primarily directly target working conditions with the aim of promoting and maintaining of the highest degree of physical, mental, and social well-being of workers in all occupations. In addition, as participatory elements of organizational interventions in the final definition, ideally, all workers participate in every step of the intervention, while participating in part of the steps of the intervention in some cases. Furthermore, in principle, all workers participate in each step of intervention, while it is also acceptable that only elected representatives among workers participate in the intervention.

Usage of the Brief Job Stress Questionnaire: A Systematic Review of a Comprehensive Job Stress Questionnaire in Japan from 2003 to 2021.

The Brief Job Stress Questionnaire (BJSQ) is used widely in occupational health studies and practice. Summarizing scientific production based on measurement is crucial. This study aimed to systematically review observational studies that used the BJSQ and the New BJSQ to show their usability. A systematic search was conducted for studies investigating relationships between the BJSQ or the New BJSQ subscales and other validated measurements on 13 September 2021, in various literature databases. The BJSQ subscales, scoring methods, and other validated measurements in the studies were qualitatively summarized. In total, 145 published reports between 2003 and 2021 were included. Among the BJSQ subscales, job stressors (n = 95) such as quantitative job overload (n = 65) and job control (n = 64) were most often used. The subscales were utilized to investigate the relationships with several other measurements. Five reports used subscales from the New BJSQ. In the last two decades, the BJSQ and the New BJSQ help measure psychosocial factors (PF) at work and contribute to the publication of scientific papers in the occupational health field. This study would encourage the utilization of the questionnaires for future research and practice.

Effects of workplace measures against COVID-19 and employees' worry about them on the onset of major depressive episodes: A 13-month prospective study of full-time employees.

BACKGROUND: Workplace measures against COVID-19 may prevent the onset of major depressive episode (MDE) in the working population. This 13-month prospective study aimed to investigate the association of the number of workplace measures against COVID-19 and employees' worry about the measures on the onset of MDE during COVID-19 outbreaks in Japan. METHODS: Data were collected from employees by using online questionnaires at baseline (May 2020) and the 7th survey (June 2021). The onset of MDE during the follow-up was retrospectively measured at the 7th survey, with a self-report scale based on the Mini-International Neuropsychiatric Interview according to the DSM-IV/DSM-5 criteria. Participants were asked to report the number of workplace measures against COVID-19 in their companies/organizations and their worry about these measures (scored 0-3). Multiple logistic regression was conducted of MDE on the number of workplace measures and worry about these, adjusting for demographic and work-related covariates and psychological distress at baseline. RESULTS: Among 968 respondents employed in May 2020, 827 completed the 7th survey in June 2021 (80%). We excluded 75 respondents who reported they had an MDE in May 2020 or earlier. Worry about workplace measures was significantly associated with the onset of MDE after adjusting for the covariates (OR for 1 score increase, 1.53; 95% CI, 1.02-2.32; p = 0.042). No significant association was found between the number of workplace measures and the onset of MDE. CONCLUSIONS: Worrying about workplace measures taken by company/organization may be a risk factor for the onset of an MDE among employees during the COVID-19 pandemic.

Usefulness of Implementation Outcome Scales for Digital Mental Health (iOSDMH): Experiences from Six Randomized Controlled Trials.

OBJECTIVES: Measuring implementation outcomes for digital mental health interventions is essential for examining the effective delivery of these interventions. The "Implementation Outcome Scale of Digital Mental Health" (iOSDMH) has been validated and used in several trials. This study aimed to compare the iOSDMH for participants in six randomized controlled trials (RCTs) involving web-based interventions and to discuss the implications of the iOSDMH for improving the interventions. Additionally, this study examined the associations between iOSDMH scores and program completion rate (adherence). METHODS: Variations in total scores and subscales of the iOSDMH were compared in six RCTs of digital mental health interventions conducted in Japan. The web-based intervention programs were based on cognitive behavioral therapy (2 programs), behavioral activation (1 program), acceptance and commitment (1 program), a combination of mindfulness, behavioral activation, and physical activity (1 program), and government guidelines for suicide prevention (1 program). Participants were full-time employees (2 programs), perinatal women (2 programs), working mothers with children (1 program), and students (1 program). The total score and subscale scores were tested using analysis of variance for between-group differences. RESULTS: Total score and subscale scores of the iOSDMH among six trials showed a significant group difference, reflecting users' perceptions of how each program was implemented, including aspects such as acceptability, appropriateness, feasibility, overall satisfaction, and harm. Subscale scores showed positive associations with completion rate, especially in terms of acceptability and satisfaction (R-squared = 0.93 and 0.89, respectively). CONCLUSIONS: The iOSDMH may be a useful tool for evaluating participants' perceptions of features implemented in web-based interventions, which could contribute to improvements and further development of the intervention.

Long-term influence of unintended pregnancy on psychological distress: a large sample retrospective cross-sectional study.

This study examined the associations between childbirth decisions in women with unintended pregnancies and long-term psychological distress. An online survey of women selected from a representative research panel was conducted in July 2021. Among participants who experienced an unintended pregnancy, the childbirth decision was categorized: (i) wanted birth, (ii) abortion, (iii) adoption, and (iv) unwanted birth. Participants who made childbirth decisions more than 1 year ago were included. ANCOVA was conducted with psychological distress (Kessler 6) as the dependent variable and education, marital status, years from the decision, age of the first pregnancy, economic situation at the unintended pregnancy, and the number of persons consulted at the unintended pregnancy as covariates. Logistic regression analysis was conducted for high distress (K6 ≥ 13) by adjusting the same covariates. A total of 47,401 respondents participated in the study. Women with an experience of unintended pregnancy experienced more than 1 year before the study were analyzed (n = 7162). Psychological distress was the lowest for wanted birth and increased for abortion, adoption, and unwanted birth. In the adjusted model, abortion was associated with lower distress scores than both adoption and unwanted birth. Compared to the wanted birth, adoption and unwanted birth showed significantly higher levels of distress (adjusted odds ratio [aOR] = 2.03 [95% CI 1.36-3.04], aOR = 1.64 [95% CI 1.04-2.58], respectively). Long-term effects on psychological distress differed according to the childbirth decisions in unintended pregnancy. Healthcare professionals should be aware of this hidden effect of unintended pregnancy experience on women's mental health.

The effect of job strain and worksite social support on reported adverse reactions of COVID-19 vaccine: A prospective study of employees in Japan.

OBJECTIVES: This prospective study aimed to examine the association of psychosocial working conditions with adverse reactions after receiving COVID-19 vaccination in a sample of employees in Japan. METHODS: The data were retrieved from an online panel of full-time employees (E-COCO-J). The analysis included participants who were employed and were not vaccinated at baseline (June 2021) but received vaccination at a 4-month follow-up (October 2021). An 11-item scale measured the adverse reactions. Four types of psychosocial working conditions (i.e., job demands, job control, and supervisor and coworker support) were measured using the Brief Job Stress Questionnaire. Multiple linear regression analyses were conducted to examine the relationship between the psychosocial working conditions and adverse reactions of COVID-19 vaccines, adjusting for socioeconomic variables, chronic disease, the number of vaccination, type of vaccine, anxiety for adverse reactions, fear and worry about COVID-19, and psychological distress at baseline. RESULTS: Overall, 747 employees were included in the analysis. The average number of adverse reactions was 3.8 (standard deviation = 2.2): Arm pain (81.1%), fatigues (64.1%), muscle pains (63.3%), and fever (37.5°C+) (53.5%) were reported more frequently. Coworker support score was significantly and negatively associated with the numbers of adverse reactions (standardized ß = -0.100, P = .023). Women, young age, second-time vaccination, Moderna, and high psychological distress were significantly associated with adverse reactions. CONCLUSIONS: Employees with low coworker support may be more likely to have adverse reactions after vaccinations. The findings of this study could support that increasing workplace support may reduce adverse reactions.

The impact of workplace psychosocial factors on menstrual disorders and infertility: a protocol for a systematic review and meta-analysis.

INTRODUCTION: Workplace environment, especially psychosocial factors at work such as job strain, workplace social support, and shift work, may affect the menstrual abnormalities and fertility of female workers. However, the association between psychosocial factors at work and menstrual abnormalities or fertility is not well understood. To address this relationship, we will conduct a systematic review and a meta-analysis of the literature that has utilized a longitudinal or prospective cohort design. METHODS AND ANALYSIS: The inclusion criteria for this systematic review and meta-analysis are defined as follows: (P) adult female workers (over 18 years old), (E) the presence of adverse psychosocial factors at work, (C) the absence of adverse psychosocial factors at work, and (O) any menstrual cycle disorders, menstrual-related symptoms, or fertility. The MEDLINE, Embase, PsycINFO, PsycArticles, and Japan Medical Abstracts Society electronic databases will be used to search for published studies. The statistical synthesis of the studies included in the meta-analysis will be conducted to estimate pooled coefficients and 95% CIs. For the main analysis, we will synthesize measures of association between psychosocial factors at work and menstrual-related disorders/symptoms. At least three eligible studies will have to be gathered to conduct a meta-analysis; otherwise (i.e., if only one or two studies will be eligible and included), the results will be presented in a narrative table. We will use the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) to determine the quality of selected studies. To assess meta-bias, Egger's test, along with a funnel plot, will be used to check for publication bias. Lastly, we will examine heterogeneity using the χ2 test with Cochran's Q statistic and I2. ETHICS AND DISSEMINATION: The results and findings will be submitted and published in a scientific peer-reviewed journal and will be disseminated broadly to researchers and policymakers interested in the translatability of scientific evidence into good practices. SYSTEMATIC REVIEW REGISTRATION: The study protocol was registered at the UMIN registry (registration number: UMIN000039488). The registration date is on 14 Feb 2020. URL: https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000044704.

STRENGTH AND LIMITATIONS OF THIS STUDY: • This systematic review and a meta-analysis will investigate the associations between psychosocial factors at work and menstrual abnormalities or fertility. • This review will include only the literature that has utilized a longitudinal design. • Various outcomes related to reproductive health in female workers will be examined (e.g., fertility, premenstrual symptoms, cycle disorders, menopausal symptoms).

The preventive effect of internet-based cognitive behavioral therapy for prevention of depression during pregnancy and in the postpartum period (iPDP): a large scale randomized controlled trial.

BACKGROUND: Prevention of perinatal depression beginning from the antenatal period is essential. Therefore, this study aimed to investigate the effectiveness of recently developed internet-delivered cognitive behavioral therapy (iCBT) for preventing the onset of a major depressive episode (MDE) in the third trimester and at 3 months postpartum. METHODS: This is a two-arm, parallel-group, general-information controlled, randomized controlled trial. Participants were 5017 pregnant women at 16-20 weeks' gestation without MDE at baseline. They were randomly assigned to an iCBT (intervention; n = 2509) or general-information (control; n = 2508) group, stratified by psychological distress at baseline. The primary outcomes were the numbers of new MDE onsets, measured using the World Health Organization Composite International Diagnostic Interview 3.0, at 32 weeks' gestation and at 3 months postpartum. RESULTS: New MDE onset was reported by 59 participants (2.35%) in the intervention group and 73 (2.91%) in the control group during follow-up. Compared with the control group, the hazard ratio (HR) of MDE in the intervention group was 0.85 (95% CI 0.61-1.20), which was not significantly different. Among participants who scored between 5 and 8 on K6 at baseline, 10 (1.37%) in the intervention group reported new onset of MDE, compared with 28 (3.81%) in the control group, and the HR of MDE was 0.38 (95%CI 0.19-0.79). CONCLUSIONS: No intervention effect was found for iCBT in preventing new onset of perinatal MDE. iCBT might prevent perinatal depression only among pregnant women with subthreshold depressive symptoms. TRIAL REGISTRATION: UMIN000038190.

The Survey Measure of Psychological Safety and Its Association with Mental Health and Job Performance: A Validation Study and Cross-Sectional Analysis.

OBJECTIVES: This study validated the Japanese version of O'Donovan et al.'s (2020) composite measure of the psychological safety scale and examined the associations of psychological safety with mental health and job-related outcomes. METHODS: Online surveys were administered twice to Japanese employees in teams of more than three members. Internal consistency and test-retest reliability were tested using Cronbach's α and intra-class correlation coefficient (ICC), respectively. Structural validity was examined using confirmatory factor analysis (CFA) and exploratory factor analysis (EFA). Convergent validity was tested using Pearson's correlation coefficients. Multiple linear regression analyses were conducted to examine the relationship between psychological safety and psychological distress, work engagement, job performance, and job satisfaction. RESULTS: Two hundred healthcare workers and 200 non-healthcare workers were analyzed. Internal consistency, test-retest reliability, and convergent validity were acceptable. CFA demonstrated poor fit, and EFA yielded a two-factor structure, with team leader as one factor and peers and team forming the second factor. The total score showed significant and expected associations with all outcomes in the adjusted model for all workers. CONCLUSIONS: The Japanese version of the measure of the psychological safety scale presented good reliability and validity. Psychological safety is important for employees' mental health and performance.