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Background: Internet psychoeducational interventions improve employees' mental health. However, implementing them for employees in micro- and small-sized enterprises (MSEs) is challenging. Objectives: This randomized controlled trial examined the effectiveness of a fully automated text-based stress management program, “WellBe-LINE,” in improving mental health and job-related outcomes for employees in workplaces with fewer than 50 employees. Methods: The program was developed based on stakeholder interviews and surveys of 1000 employees at MSEs. Adult full-time employees at an enterprise with fewer than 50 employees were recruited from registered members of a web survey company in Japan. Participants were randomly allocated to the intervention or control group (1:1). Participants in the intervention group were invited to register for the program using the LINE app. Psychological distress measured by Kessler 6 (K6) was a primary outcome, with self-administrated questionnaires at baseline, 2-month (post), and 6-month follow-ups. A mixed model for repeated measures conditional growth model analysis was conducted using a group ∗ time interaction as an intervention effect. Implementation outcomes were measured through implementation outcome scales for digital mental health (iOSDMH). Results: 1021 employees were included in this study. No significant effects were shown in any outcome. The reported implementation outcomes were positively evaluated, with 80 % acceptability, 86 % appropriateness, and feasibility (ease of understanding the contents [88 %], frequency [86 %], and length of content [86 %]). Conclusions: A simple text-message program for employees at MESs was acceptable, appropriate, and feasible; however, it did not result in improved mental health or job-related outcomes. Trial registration: UMIN clinical trial registration: UMIN000050624 (registration date: March 18, 2023).

Abstract The study aimed to examine the association of expanded adverse childhood experiences (ACEs) with psychological distress in adulthood. The data from nation-wide online cohort was used for analysis. Community dwelling adults in Japan were included. The ACEs was assessed by 15 items of ACE-J, including childhood poverty and school bullying. Severe psychological distress was determined as the score of Kessler 6 over 13. Multivariable logistic regression analysis was conducted, by using sample weighting. A total of 28,617 participants were analyzed. About 75% of Japanese people had one or more ACEs. The prevalence of those with ACEs over 4 was 14.7%. Those with ACEs over 4 showed adjusted odds ratio = 8.18 [95% CI 7.14–9.38] for severe psychological distress. The prevalence of childhood poverty was 29% for 50–64 year old participants and 40% of 65 or older participants. The impact of childhood poverty on psychological distress was less than other ACEs in these age cohorts. Bullying was experienced 21–27% in young generations, but 10% in 65 or older participants. However, the impact on psychological distress in adulthood was relatively high in all age groups. ACEs have impacted mental health for a long time. Future research and practice to reduce ACEs are encouraged.

Abstract 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

BackgroundDuring the COVID-19 pandemic, health care professionals experienced high levels of depression. However, extant research has not highlighted effective internet-based psychological interventions to improve the mental health in this population during the pandemic. It remains unclear whether self-guided, internet-based cognitive behavioral therapy (iCBT) programs are effective in improving the mental health of health care workers during the COVID-19 pandemic. ObjectiveThe aim of this study was to evaluate the effectiveness of a smartphone-based iCBT stress management program for reducing the depression experienced by nurses in Vietnam and Thailand. MethodsFrom March to April 2022, a 2-arm, parallel-group randomized controlled trial was implemented. One arm offered a 7-week self-guided iCBT program, and the other offered treatment as usual as a control arm. Full-time nurses were recruited from 6 hospitals: 2 hospitals in Vietnam and 4 hospitals in Thailand. The primary outcome of this program was the severity of depression measured by the Depression Anxiety Stress Scale-21 items. Follow-up surveys were conducted to measure the change in depression severity at 3 months (July-August 2022) and at 6 months (October-November 2022) after baseline. Mixed modeling for repeated measures was used to test the effects of the intervention compared with the control for the follow-up. ResultsA total of 1203 nurses were included in this study: 602 in the intervention group and 601 in the control group. The follow-up rate at 3 and 6 months ranged from 85.7% (515/601) to 87.5% (527/602). The completion rate for the program was 68.1% (410/602). The group difference in depression was significant at the 3-month follow-up (coefficient=–0.92, 95% CI –1.66 to –0.18; P=.02) and nonsignificant at the 6-month follow-up (coefficient=–0.33, 95% CI –1.11 to 0.45; P=.41). The estimated effect sizes were –0.15 and –0.06 at the 3- and 6-month follow-ups, respectively. ConclusionsOur study shows that the smartphone-based iCBT program was effective in reducing depression at the 3-month follow-up among hospital nurses in Vietnam and Thailand during the COVID-19 pandemic. However, the effect size was small, and therefore, these results may not be clinically meaningful. Trial RegistrationUMIN Clinical Trials Registry UMIN000044145; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050128 International Registered Report Identifier (IRRID)RR2-10.20944/preprints202303.0450.v1

Abstract Aim The Mental Health Supporter Training Program is a national project conducted in Japan. This study aimed to determine the effects on mental health‐related stigma, mental health literacy, and knowledge about mental health difficulties and support techniques among program participants. Methods The target population was local residents of a wide range of generations in Japan. Outcomes were assessed at baseline (T1), immediately postintervention (T2), and at the 6‐month follow‐up (T3). A mixed model for repeated‐measures conditional growth model analyses were employed to examine the effects of the intervention over time (T1, T2, T3). We also calculated effect sizes using Cohen's d. Results The program had a significantly favorable pooled effect on the Japanese version of the Reported and Intended Behaviour Scale score after adjusting for covariates (reported behavior [t = 3.20, p = 0.001]; intended behavior [t = 8.04, p

Abstract 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 (

Abstract 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.

Objectives The aim of this study was to investigate the association of living condition (deprivation and urbanisation level) with loneliness and social isolation.Study design Cross-sectional study.Methods Data were retrieved from the Japan COVID-19 and Society Internet Survey, a nationwide online cohort study, conducted from September to October 2021. Area Deprivation Index and Densely Inhabited District data were used as indicators of living condition. The Japanese version of the University of California, Los Angeles Loneliness Scale and Lubben Social Network Scale-6 were used to assess loneliness and social isolation, respectively. Analysis of covariance was performed to compare the difference in outcome variables by living conditions (four categories), adjusting for gender, age, educational attainment, income, marital status, people living with, work status and subjective health status.Results A total of 27 520 community dwelling people were included in this study. For loneliness, living condition did not show a significant difference in the adjusted model, while deprived area had a tendency to show high loneliness. For social isolation, there was a significant group difference in the adjusted model (p

Objectives This study aimed to evaluate the association between pre-pregnancy menstrual cycle characteristics (i.e. cycle-length variability and cycle length) and antenatal depression. Methods This study retrieved the data from the baseline survey of the randomized controlled trial with pregnant women at 16–20 weeks gestation who used a pregnancy tracking app. The antenatal depression was assessed using the Edinburgh Postnatal Depression Scale (EPDS) at 16–20 weeks gestation, and the cutoff point of 10/11 was adopted. Pre-conceptional menstrual cycle information was obtained via a prerecorded period tracking app. Cycle-length variability was defined as the average difference in the lengths between cycles, dichotomized into regular (≤6 days) and irregular (>6 days). Cycle length was coded as a categorical variable: 6 days) was significantly associated with high EPDS scores (adjusted: standardized beta = 0.049, p = 0.003) and with high cutoff EPDS scores (over 11) (adjusted OR = 1.40 [1.02–1.94], p = 0.038) but not with cycle length. Conclusion Irregular menstrual cycle before pregnancy was associated with depression during pregnancy. The health of the menstrual cycle during preconception needs to be further explored to promote healthy maternal mental health.

Article Summary 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).

OBJECTIVE: This study aimed to investigate the prospective effects of corporate and organizational workplace measures against COVID-19 on reducing employees` psychological distress during a 12-month follow-up in the COVID-19 pandemic. METHODS: Data were retrieved from an online longitudinal panel survey of full-time employees in Japan, with the 1^st survey in March 2020, and the 2^nd to 6^th surveys in May, August, November 2020, February and March 2021, respectively. Seven area-specific workplace measures were assessed using a self-report 23-item scale at the 2^nd follow-up. Psychological distress was measured using an 18-item scale of the Brief Job Stress Questionnaire at each survey. Linear regressions and mixed model analysis were conducted of psychological distress at follow-ups on scores of the area-specific workplace measures, adjusting for psychological distress and other covariates at the 1^st survey. RESULTS: A total of 941 employees responded at baseline; most of them (86.9–90.9%) participated in the follow-up surveys. Linear regression analysis indicated that workplace measures of facilitating employees’ preventive measures (ie, hygiene behaviors) statistically significantly and negatively correlated with psychological distress at the 5^th survey [b=-0.518, standard error (SE) 0.259, P=0.046]. A statistically significant and negative interaction between the scores and time of follow-up was observed in the mixed model analysis (b=-0.096, SE 0.047, P=0.041). No such correlation or interaction was found for any of other subcategorical workplace measures. CONCLUSIONS: The study provides prospective evidence for a protective effect of workplace measures to facilitate employee’s hygiene behaviors on reducing psychological distress of full-time employees in the COVID-19 pandemic. The association seems stronger at a later follow-up.

Objectives: Work-related subjective well-being (SWB) may be negatively affected by early-life adverse experiences, such as school bullying experience. This study aimed to identify the association between work-related SWB and school bullying experiences. Methods: A systematic review was conducted using five electronic databases to search for published observational studies from inception to May 5th, 2022. Eligibility criteria included the original papers in English, which measured school bullying experiences and work-related SWB (eg, satisfaction, engagement). Eight researchers independently conducted screening and a full-text review. We used the Risk of Bias Assessment tool for Non-randomized Studies to assess the certainty of the evidence. Narrative data were summarized. The study has been registered at UMIN-CTR (UMIN000040513). Results: A total of 6,842 studies were initially searched. We included two cross-sectional studies. Both studies were rated as high risk for bias in exposure measurements and incomplete outcome data. These studies showed conflicting results. One study reported that school bullying was negatively associated with job satisfaction among British lesbian, gay, or bisexual workers; on the other hand, another study reported that school bullying was positively associated with work engagement among Japanese workers. Conclusions: We found limited inconsistent evidence for the association between work-related SWB and school bullying experiences.

Abstract Aim Previous studies evaluated the association between eating alone and mental health mainly in older people and adolescents. This study aimed to evaluate the association between dinner frequency with others and psychological distress during the COVID‐19 outbreak among the Japanese working population. Methods Data were acquired from a prospective online cohort study (the Employee Cohort Study in the COVID‐19 pandemic in Japan) conducted in February 2021 as a cross‐sectional design. Dinner frequency with others was categorized into five groups: “almost daily,” “4–5 times per week,” “2–3 times per week,” “once per week,” and “less than once per week,” setting them as a predictor variable. Modified Poisson regression was performed to calculate the prevalence ratio of psychological distress with multiple imputation for missing data. Global fear and worry about COVID‐19 were adjusted as a covariate. Results A total of 1171 participants completed the questionnaire. Respondents who ate dinner with others “almost daily” had the least psychological distress than those who ate with others “4–5 times,” “2–3 times,” and “once per week” in the crude model (prevalence ratio (95% CI): 1 [reference], 1.34 [1.08–1.67], 1.40 [1.15–1.69], 1.44 [1.12–1.85], respectively). The association was comparable after adjusting for global fear and worry about COVID‐19. Conclusions Among those who ate dinner with others at least once a week, those who ate with others “almost daily” had the least psychological distress. The association was comparable after adjusting for global fear and worry about COVID‐19. Further study is needed on why those who eat with others less than once a week may have a lower prevalence ratio of having mental distress.

Abstract Objectives This study aimed to examine the effectiveness of vaccination to improve mental health among employees in Japan based on a prospective study. Methods The data were retrieved from the Employee Cohort Study conducted during the COVID‐19 pandemic in Japan (E‐ COCO‐J) at T1 (4–10 February 2021) and T2 (22–29 June 2021). Psychological distress was measured by using an 18‐item scale of the Brief Job Stress Questionnaire (BJSQ). The analytic sample was limited to individuals employed at both T1 and T2 without missing covariates. Vaccination status was measured at T2. Statistical analysis was conducted to test the differential change in the psychological distress at T1 and T2 with the time × group interactions by using repeated ANOVA, adjusting for the covariates (gender, age, marital status, education, chronic disease, company size, industry, and occupation). Results Of the total sample (N = 948), 105 (11.1%) were vaccinated at least once at T2. The crude mean scores of psychological distress at T1 and T2 were 41.8 and 42.0 for vaccinated participants and 41.2 and 41.2 for nonvaccinated participants, respectively, with no significant effect of having been vaccinated (Cohen's d = 0.02, P = 0.833). After adjusting the covariates, there was no significance (P = 0.446). Conclusions The COVID‐19 vaccination was supposed to have a limited effect on mental health among Japanese employees in an early phase of vaccination. To keep providing mental health care for employees is important even after starting the vaccination program.

Highlights • The ES-J was a highly sensitive clinimetric index. • The ES-J distinguished healthy subjects from those with past or current major depression. • The ES-J was highly sensitive to sub-threshold symptoms of depression. • The ES-J was a valid screening measure. • The ES-J can be used to detect a kind of vulnerability and risk of relapse.

Objectives: This 2-month cohort study aimed to investigate the changing prevalence and factors associated with COVID-19-related workplace bullying among the general workers in Japan. Methods: A baseline survey was conducted of 4,120 full-time workers at Time 1 (March 2020) and they were invited to a follow-up survey at Time 2 (May 2020) after the outbreak of COVID-19 in Japan. The prevalence of COVID-19-related workplace bullying was compared between Time 1 and Time 2 by using McNemar’s test. Multiple logistic regression analysis was conducted to investigate the associations between occupation (health care and non-health care workers), socioeconomic status, living in areas under the national emergency announcement, workplace measures against COVID-19, occupational class, chronic physical comorbidities, chronic mental comorbidities, and COVID-19-related workplace bullying at Time 2, adjusting for that at Time 1. Results: A total of 1,421 responded to the survey at Time 2. Data from 996 respondents after excluding 36 who retired during the follow-up were analyzed. The prevalence of COVID-19-related workplace bullying increased more than double from Time 1 (2.8%) to Time 2 (6.5%). Being a manual worker (OR=3.80), having higher education (OR=2.37), and having chronic physical comorbidity (OR=2.11) was significantly associated with the COVID-19-related workplace bullying at Time 2. Conclusions: COVID-19-related workplace bullying increased during the outbreak of COVID-19 in Japan. A lower-class occupation (manual workers) and having chronic physical comorbidity may be associated with greater victimization of COVID-19-related workplace bullying, while those with high educational attainment may be more sensitive to it.

Abstract There are growing concerns on stress among nurses in low- and middle-income countries (LMICs) in South-East Asia. It is important to improve mental health among nurses in these countries. The objective of this study was to examine the efficacy of two types of newly developed smartphone-based stress management programs in improving depressive and anxiety symptoms among hospital nurses in Vietnam. This study was a three-arm (including two intervention groups and one control group) randomized trial. Participants were recruited from nurses in a large general hospital in Hanoi, Vietnam. Two types (free-choice and fixed sequential order) of smartphone-based stress management programs were developed. Participants were randomly allocated to Program A (a free-choice, multimodule stress management), Program B (a fixed-order, internet cognitive behavioral therapy, iCBT), or a control group (treatment as usual). The depressive and anxiety symptoms were measured by using the Depression Anxiety and Stress Scales at baseline, 3-, and 7-month follow-up surveys. 951 participants were randomly allocated to each of the three groups. Program B showed a statistically significant effect on improving depressive symptoms at 3-month (p = 0.048), but not at 7-month (p = 0.92); Cohen’s d was − 0.18 (95% CI − 0.34 to − 0.02) and 0.03 (95% CI − 1.00 to 1.05), respectively. Program A failed to show a significant intervention effect on any of the outcomes at 3- or 7-month follow-up (p > 0.05). Despite the small effect size, the present fixed-order iCBT program seems effective in improving depression of hospital nurses in Vietnam. A public health impact of the intervention can be scalable, when considering its accessibility and minimal cost. Trial registration number: The study protocol is registered at the UMIN Clinical Trials Registry (UMINCTR; ID = UMIN000033139). Registered date of the protocol is 1st Jul. 2018. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037796

Abstract Background Child abuse and postnatal depression are two public health problems that often co-occur, with rates of childhood maltreatment highest during the first year of life. Internet-based behavioural activation (iBA) therapy has demonstrated its efficacy for improving postnatal depression. No study has examined whether the iBA program is also effective at preventing child abuse. This study aims to investigate whether iBA improves depressive symptoms among mothers and prevents abusive behaviours towards children in postpartum mothers in a randomized controlled trial, stratifying on depressive mood status. The study also evaluates the implementation aspects of the program, including how users, medical providers, and managers perceive the program in terms of acceptability, appropriateness, feasibility, and harm done. Methods The study is a non-blinded, stratified randomized controlled trial. Based on cut-off scores validated on Japanese mothers, participants will be stratified to either a low Edinburgh Postnatal Depression Scale (EPDS) group, (EPDS 0–8 points) or a high EPDS group (EPDS ≥9 points). A total of 390 postnatal women, 20 years or older, who have given birth within 10 weeks and have regular internet-access will be recruited at two hospitals. Participants will be randomly assigned to either treatment, with treatment as usual (TAU) or through intervention groups. The TAU group receives 12 weekly iBA sessions with online assignments and feedback from trained therapists. Co-primary outcomes are maternal depressive symptoms (EPDS) and psychological aggression toward children (Conflict Tactic Scale 1) at the 24-week follow-up survey. Secondary outcomes include maternal depressive symptoms, parental stress, bonding relationship, quality of life, maternal health care use, and paediatric outcomes such as physical development, preventive care attendance, and health care use. The study will also investigate the implementation outcomes of the program. Discussion The study investigates the effectiveness of the iBA program for maternal depressive symptoms and psychological aggression toward children, as well as implementation outcomes, in a randomized-controlled trial. The iBA may be a potential strategy for improving maternal postnatal depression and preventing child abuse. Trial registration The study protocol (issue date: 2019-Mar-01, original version 2019005NI-00) was registered at the UMIN Clinical Trial Registry (UMIN-CTR: ID UMIN 000036864 ).

Abstract Aims This systematic review aimed to evaluate randomized controlled trials (RCTs) to examine the effect of maternal and infant sleep intervention during women's pregnancy for the purpose of preventing perinatal depression. Method A systematic search (from inception to January 28, 2019) for RCTs using five electronic databases—the Cochrane Controlled Register of Trials (CENTRAL), Embase, PubMed, PsycINFO, and Ichushi Web (Japan Medical Abstracts Society)—was conducted. Twelve investigators independently conducted initial screenings based on title and abstract, and then, two researchers performed full‐text reviews one by one. A meta‐analysis would be conducted if at least three studies were found. However, only two articles that met inclusion criteria, and narrative data synthesis was conducted for these two articles. The study protocol has been registered at PROSPERO (CRD42019119999). Result A total of 13 654 studies were initially searched. After removing duplicates, 10 547 studies were screened, and finally, two studies met the inclusion criteria. In both studies, the intervention was a one‐time face‐to‐face session during pregnancy to deliver the behavioral knowledge and skills for optimizing sleep hygiene for both infant and mother. Effectiveness of the intervention in improving maternal mood was not significant in one study. In the other, there was a significant difference in maternal mood between the intervention and control group. No mood comparison was made between baseline and postintervention. Conclusion This study found limited evidence to support the effectiveness of sleep intervention for all pregnant women, which means “universal intervention,” to protect maternal mental health. Further well‐designed RCTs are needed to confirm these findings.

BackgroundThe prolonged COVID-19 pandemic has affected mental health among workers. Psychoeducational intervention via a website could be effective for primary prevention of mental illness among workers in the current COVID-19 pandemic. ObjectiveThe aim of this randomized controlled trial is to examine the effect of a newly developed online psychoeducational website named Imacoco Care on reducing psychological distress and fear about COVID-19 infection among workers. MethodsParticipants in the study were recruited from registered members of a web survey company in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to the intervention or control group. Participants in the intervention group were invited to access the Imacoco Care program within a month after the baseline survey. The Kessler Psychological Distress Scale (K6) and the Fear of COVID-19 Scale (FCV-19S) scores were obtained at baseline and at 1- and 3-month follow-ups. ResultsA total of 1200 workers were randomly allocated to the intervention and control groups (n=600 [50%] per group). The Imacoco Care intervention group showed a significant favorable effect on K6 scores (P=.03) with a small effect size (ES; Cohen d=–0.14) and an adverse effect on FCV-19S scores (P=.01) with a small ES (Cohen d=0.16) at 3-month follow-up. In the per protocol analysis (including only participants who had read the Imacoco Care content at least 1 time), the Imacoco Care intervention group also showed a significant favorable effect on reducing K6 scores (P=.03), while an adverse effect on FCV-19S scores was not significant (P=.06) in the intervention group at 3-month follow-up. ConclusionsA web-based psychoeducation approach may be effective for improving psychological distress among workers; however, it may be important not only to distribute information but also to encourage active engagement with the content of the program to prevent adverse effects of psychoeducational intervention. Trial RegistrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042556; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048548

OBJECTIVES: This study compared the longitudinal change in the mental health of healthcare and non-healthcare workers during two months of the COVID-19 outbreak in Japan. METHODS: Data were derived from a prospective online cohort study of 1448 full-time employees in Japan. Participants were surveyed at baseline from 19–22 March 2020 (T1) and at follow-up from 22–26 May 2020 (T2). A self-administered online questionnaire was used to assess participants’ fear and worry of COVID-19, psychological distress, and physical symptoms at T1 and T2. A series of generalized linear models were created to assess changes in outcomes between healthcare and non-healthcare workers. Demographic variables (ie, sex, age, marital status, child[ren], education, and residential area) were included in the models as covariates. RESULTS: A total of 1032 participants completed the follow-up questionnaire at T2 (follow-up rate, 72.6%). After excluding unemployed respondents (N=17), the final sample comprised 1015 full-time employees (111 healthcare and 904 non-healthcare workers). After adjusting for the covariates, psychological distress (and subscales of fatigue, anxiety, and depression) as well as fear and worry of COVID-19 increased statistically significantly more among healthcare than non-healthcare workers from T1 to T2. CONCLUSIONS: Psychological distress, together with fear and worry of COVID-19, increased more among healthcare compared to non-healthcare workers during the COVID-19 outbreak. The study confirmed that healthcare workers are an important target for mental healthcare during the COVID-19 outbreak.

Abstract Background Personal values, which are formed in early life, can have an impact on health outcome later in life. Objective The aim of this study is to investigate the relation between personal values in adolescence and bio-indicators related to metabolic syndrome (MetS) in adulthood. Participants and Methods The longitudinal data used was from the Japanese Study on Stratification, Health, Income, and Neighborhood (J-SHINE). Personal values in adolescence were retrospectively obtained in 2017 from a self-reporting questionnaire, composed of value priorities and commitment to the values. Venous samples were collected in 2012 for low and high-density lipoprotein (LDL, HDL) cholesterol and hemoglobin A1c (HbA1c). Body mass index (BMI), waist circumference and systolic and diastolic blood pressure (SBP, DBP) were also measured. The associations of each variable were examined by partial correlation analysis. In addition, multiple linear regression analysis was conducted to examine overall associations between personal values and the sum of standardized scores (Z-score) of the biomarkers as a proxy of MetS. Results The total population (n = 668) included 261 men and 407 women. For men, the personal value priority of “Having influence on society” was associated with high HDL cholesterol (0.133, p = 0.032) and “Cherishing familiar people” with low waist circumference (r = -0.129, p = 0.049), low SBP, and high DBP (r = -0.135, p = 0.039; r = 0.134, p = 0.041). For women, “Not bothering others” was associated with high SBP and low DBP (r = 0.125, p = 0.015; r = -0.123, p = 0.017). "Economically succeeding" was associated with a worse outcome (β = 0.162, p = 0.042) in men. Conclusions Although some significant associations were found between personal values in adolescence and MetS-related markers in adulthood, the overall associations were not strong. Culturally prevailing values were likely to be associated with a good outcome of metabolic health.

Abstract Background The aim of this study was to examine the internal consistency, structural validity, and convergent/known-group validity of the Japanese version of the 42-item Psychological Well-Being Scale (PWBS-42). Methods The PWBS-42 includes six 7-item subscales designed to measure the following dimensions of eudaimonic psychological well-being: 1) autonomy, 2) environmental mastery, 3) personal growth, 4) positive relations with others, 5) purpose in life, and 6) self-acceptance. A questionnaire was administered to 2102 community residents in Tokyo aged 30 or over as a part of the Midlife in Japan (MIDJA) survey, in 2008. The internal consistency reliability was tested using Cronbach’s α. Structural validity was examined using exploratory factor analysis (EFA). Convergent validity was evaluated by calculating correlations of the Japanese PWBS-42 subscales with life satisfaction, negative affect, negative adjectives, positive affect, positive adjectives, self-esteem, and perceived stress scales. Results Data from 1027 respondents (505 males and 522 females) were analyzed (valid response rate = 56.2%). Cronbach’s α values ranged from 0.70 to 0.78 for five of the subscales, while that for purpose in life was lower (0.57). EFA yielded a five-factor structure: The first two factors consisted of negative and positive items mostly from the environmental mastery, purpose in life, and self-acceptance subscales. The third, fourth, and fifth factors consisted mostly of items from the positive relations with others, autonomy, and personal growth subscales, respectively. As hypothesized, the scores for life satisfaction, negative and positive affect/adjectives, self-esteem and perceived stress were significantly correlated with all subscales of the Japanese PWBS-42. Conclusion The subscales of the Japanese version of the PWBS-42 showed accep. levels of reliability and support for convergent validity in the Japanese population. The factor structure was slightly different from the theoretical 6-factor model: items of three subscales (environmental mastery, purpose in life, and self-acceptance) loaded together on two factors. This finding may be interpreted in light of the interdependent self construal found in Japan in which these three components could be closely linked.

Abstract Background Prevention of antenatal and postnatal depression is crucial, given its high prevalence and severe consequences. Although several systematic reviews and meta-analyses have examined the effects of psychological interventions on the population at risk for perinatal depression, few studies have focused on universal prevention and none have focused specifically on universal prevention in pregnancy. The aim of this study is to examine the effects of psychological interventions with a universal prevention focus on perinatal depression during pregnancy by performing a systematic review and meta-analysis based on both the latest articles and a broader literature search. Methods The literature search will be conducted using the Cochrane Controlled Register of Trials (CENTRAL), Embase, PubMed and PsycINFO, from inception onwards. Randomized controlled trials that examined the association between psychological interventions and universal prevention of antenatal and postnatal depression among pregnant women will be included. Study selection, data collection, quality assessment, and statistical syntheses will be conducted following a priori defined methods in the protocol. Discussion The findings of this systematic review and meta-analysis will have both clinical and political importance in the context of perinatal mental health. In addition, this study will promote future studies and clarify the direction of research on universal prevention of perinatal depression. Systematic review registration PROSPERO CRD42019118041

BackgroundDigital mental health interventions are being used more than ever for the prevention and treatment of psychological problems. Optimizing the implementation aspects of digital mental health is essential to deliver the program to populations in need, but there is a lack of validated implementation outcome measures for digital mental health interventions. ObjectiveThe primary aim of this study is to develop implementation outcome scales of digital mental health for different levels of stakeholders involved in the implementation process: users, providers, and managers or policy makers. The secondary aim is to validate the developed scale for users. MethodsWe developed English and Japanese versions of the implementation outcome scales for digital mental health (iOSDMH) based on the literature review and panel discussions with experts in implementation research and web-based psychotherapy. The study developed acceptability, appropriateness, feasibility, satisfaction, and harm as the outcome measures for users, providers, and managers or policy makers. We conducted evidence-based interventions via the internet using UTSMeD, a website for mental health information (N=200). Exploratory factor analysis (EFA) was conducted to assess the structural validity of the iOSDMH for users. Satisfaction, which consisted of a single item, was not included in the EFA. ResultsThe iOSDMH was developed for users, providers, and managers or policy makers. The iOSDMH contains 19 items for users, 11 items for providers, and 14 items for managers or policy makers. Cronbach α coefficients indicated intermediate internal consistency for acceptability (α=.665) but high consistency for appropriateness (α=.776), feasibility (α=.832), and harm (α=.777) of the iOSDMH for users. EFA revealed 3-factor structures, indicating acceptability and appropriateness as close concepts. Despite the similarity between these 2 concepts, we inferred that acceptability and appropriateness should be used as different factors, following previous studies. ConclusionsWe developed iOSDMH for users, providers, and managers. Psychometric assessment of the scales for users demonstrated acceptable reliability and validity. Evaluating the components of digital mental health implementation is a major step forward in implementation science.

Objectives This study investigated the change in suicidal ideation and its risk factors among employees. A longitudinal cohort study was conducted, starting with the baseline online survey in March 2020 (T1), followed by May (T2), and August (T3). The change in suicidal ideation from T2 to T3 and relevant factors associated with suicidal ideation at T3 were examined. Suicidal ideation significantly increased between May and August 2020 among females, younger (under 39 years old), highly educated population, and those without pre-existing mental health conditions. Factors significantly associated with suicidal ideation were younger age, suicidal ideation at T2, and with pre-existing mental health conditions. Loneliness at T2 showed a significant association with suicidal ideation, if adjusting those without pre-existing mental health conditions. National and community support is needed to target people who are likely to be left behind, such as young people and those with pre-existing mental health conditions, in the pandemic. Method A longitudinal study was conducted with a cohort of full-time employees, starting with the baseline online survey in March 2020 (time point 1), followed by May (time point 2) and August (time point 3). The change in suicidal ideation from time point 2 to 3, and relevant factors associated with suicidal ideation at time point 3, were examined. Results Suicidal ideation significantly increased between time points 2 and 3 among women, younger people (aged

BackgroundThe effect of an unguided internet-based cognitive behavioral therapy (iCBT) stress management program on depression may be enhanced by applying artificial intelligence (AI) technologies to guide participants adopting the program. ObjectiveThe aim of this study is to describe a research protocol to investigate the effect of a newly developed iCBT stress management program adopting AI technologies on improving depression among healthy workers during the COVID-19 pandemic. MethodsThis study is a two-arm, parallel, randomized controlled trial. Participants (N=1400) will be recruited, and those who meet the inclusion criteria will be randomly allocated to the intervention or control (treatment as usual) group. A 6-week, six-module, internet-based stress management program, SMART-CBT, has been developed that includes machine-guided exercises to help participants acquire CBT skills, and it applies machine learning and deep learning technologies. The intervention group will participate in the program for 10 weeks. The primary outcome, depression, will be measured using the Beck Depression Inventory II at baseline and 3- and 6-month follow-ups. A mixed model repeated measures analysis will be used to test the intervention effect (group × time interactions) in the total sample (universal prevention) on an intention-to-treat basis. ResultsThe study was at the stage of recruitment of participants at the time of submission. The data analysis related to the primary outcome will start in January 2022, and the results might be published in 2022 or 2023. ConclusionsThis is the first study to investigate the effectiveness of a fully automated machine-guided iCBT program for improving subthreshold depression among workers using a randomized controlled trial design. The study will explore the potential of a machine-guided stress management program that can be disseminated online to a large number of workers with minimal cost in the post–COVID-19 era. Trial RegistrationUMIN Clinical Trials Registry（UMIN-CTR) UMIN000043897; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050125 International Registered Report Identifier (IRRID)PRR1-10.2196/30305

Abstract Background Depression is a major problem among nurses; hence, it is important to develop a primary prevention strategy to manage depression among nurses. This randomized controlled trial (RCT) study aims to investigate the effects of a newly developed internet-based cognitive behavioral therapy (iCBT) program on depressive symptoms, measured at baseline and three- and six-month follow-ups, among nurses in Japan. Methods Nurses working at three university hospitals, one public hospital, and twelve private hospitals who meet inclusion criteria will be recruited and randomized either to the intervention group or the control group (planned N = 525 for each group). The newly developed iCBT program for nurses consists of six modules, which cover different components of cognitive behavioral therapy (CBT); transactional stress model (in module 1), self-monitoring skills (in module 2), behavioral activation skills (in module 3), cognitive restructuring skills (in modules 4 and 5), relaxation skills (in module 5), and problem-solving skills (in module 6). Participants in the intervention group will be asked to read these modules within 9 weeks. The primary outcome will be depressive symptoms as assessed by the Beck Depression Inventory-II (BDI-II) at baseline, three-, and six-month follow-ups. Discussion The greatest strength of this study is that it is the first RCT to test the effectiveness of the iCBT program in improving depressive symptoms among nurses. A major limitation is that all measurements, including major depressive episodes, are self-reported and may be affected by situational factors at work and participants’ perceptions. Trial registration This trial was registered at the University Hospital Medical Information Network clinical trials registry (UMIN-CTR; ID = UMIN000033521) (Date of registration: August 1, 2018).

Objectives: This study aimed to investigate workplace measures implemented in response to COVID-19 during the outbreak in Japan from T1 (March 2020) to T2 (May 2020), focusing on the disparities by company size and industry. Methods: A longitudinal study was conducted using a cohort of full-time employees, starting with the baseline online survey on March 19–22, 2020 (T1). An online follow-up survey was conducted on May 22–26, 2020 (T2). The McNemar test was used to assess differences between T1 and T2 in the proportion of implemented measurements. Analysis of covariance was performed to compare the differences in the number of implemented measures across groups classified by company size or industry, adjusting for sex and age. Results: A total of 1,032 participants (response rate: 72.6%) completed the follow-up questionnaire. The final analytic sample comprised n=987. The workplace measures involving the delivery of information on COVID-19 were 88.4% at T2, which significantly increased from T1 (increased 8.6%, p

Introduction This randomised controlled trial (RCT) aims to examine the effects of an internet-delivered acceptance and commitment therapy (iACT) programme (‘Happiness Mom’) on the psychological well-being of working mothers.Methods and analysis The target population of the RCT will be employed mothers with at least one preschool child. Participants who fulfil the study’s eligibility criteria will be randomly assigned either to an iACT intervention group (n=200) or to a wait-list control group (n=200). Participants in the intervention groups will be asked to complete the programme within 12 weeks of the baseline survey. The intervention programme contains eight modules based on ACT. Primary outcomes are six components of psychological well-being, based on Ryff’s theory. Secondary outcomes are intention to leave their job, work engagement, work performance, sick leave days, psychological distress, euthymia, positive emotions, job and life satisfaction, social support and parental burn-out.Ethics and dissemination Ethical approval for this study has been obtained from the Research Ethics Review Board of Graduate School of Medicine, the University of Tokyo (No. 2019134NI). If the intervention programmes are found to be significantly beneficial, the programmes can be made available for all working mothers with preschool children in Japan.Discussion This study will contribute to the development of an internet-based self-care programme that is effective, feasible, low cost and accessible to improve the well-being of working mothers.Trial registration number UMIN000039918.

Objectives: This study aimed to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) to improve subjective well-being (SWB), including evaluative, hedonic, and eudemonic well-being, and the mental component of quality of life (QOL) of working population.Methods: A literature search was conducted, using PubMed, Embase, PsycINFO, and PsycARTICLES. Eligible studies included those that were RCTs of any intervention, conducted among healthy workers, measured SWB as a primary outcome, and original articles in English. Study characteristics, intervention, outcomes, and results on SWB outcomes were extracted by the investigators independently. After a brief narrative summarizing and classifying the contents of the interventions, the included outcomes were categorized into each aspect of SWB (evaluative, hedonic, and eudemonic well-being, and the mental component of QOL). Finally, the characteristics of the effective interventions for increasing each aspect were summarized, and the pooled effect of interventions on SWB was investigated by a meta-analysis. Publication bias was investigated by drawing a funnel plot and conducting Egger's test.Results: From the 5,450 articles found, 39 met the inclusion criteria for the systematic review. The interventions included in this review were classified into six categories (physical activity, ergonomics, psychological, environmental, multicomponent intervention, and others). The meta-analysis from 31 studies showed that the pooled effect of included interventions on SWB was significantly positive (standardized mean difference (SMD) = 0.51; standard error (SE) = 0.10). A funnel plot showed there were extremely large or small SMDs, and Egger's test was significant. Thus, we conducted sensitivity analysis, excluding these extreme SMDs, and confirmed that the estimated pooled effect was also significantly positive. Subgroup analyses for separate types of interventions showed the effects of psychological interventions (e.g., mindfulness, cognitive behavioral based approach, and other psychological interventions) were also significantly positive.Conclusion: The current study revealed the effectiveness of interventions for increasing SWB. Specifically, psychological interventions (e.g., mindfulness, cognitive behavioral based approach, and other psychological interventions) may be useful for improving SWB.

Objectives: The aim of the study was to investigate the number of workplace measures implemented to respond to the COVID-19 epidemic reported by employees and their association with company size and industry among employees in Japan. Methods: A cross-sectional online questionnaire survey was conducted of full-time employees in Japan from March 19–22, 2020. Questions were about announcements by the company of measures taken and 23 items of workplace measures. Associations of company size and industry with the announcements and the number of workplace measures were analyzed. Results: The final sample consisted of 1,379 respondents. The mean number of implemented preventive measures for COVID-19 among 23 items was 11.2 (standard deviation, 5.9). Proportions of respondents who reported receiving announcement of measures taken was high (79.9%), as were proportions of respondents reporting implementation of some of the workplace measures, while the less than half reported implementation of most of the workplace measures. The announcement of measures and the number of workplace measures that were implemented in the workplace were generally lower/smaller among respondents in smaller companies and in retail, wholesale, and transportation industries. Conclusions: While most respondents reported receiving information about measures by their companies/organizations, it may be a further challenge to implement workplace measures in smaller companies and companies in retail, wholesale, and transportation industries.

Introduction The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive–behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.Methods and analysis The target study population will be pregnant women of 16–20 weeks gestation who are currently users of ‘Luna Luna Baby’, the most widely used app for pregnant women in Japan. Those who meet the eligibility criteria will be randomly allocated to the 6-module internet CBT programme that was newly developed for pregnant women (n=2500), or to a treatment-as-usual control group (n=2500). Participants in the intervention groups will be required to complete the programme by 32 weeks gestation. The primary outcomes are the number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview 3.0 at 32 weeks gestation and 3 months post partum. Survival analysis will be conducted to test for the effectiveness of the intervention on the time to the onset of MDE.Ethics and dissemination The study plan has been approved by the Research Ethics Review Board of the Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (2019150NI). If the intervention programmes are found to produce a significant positive effect in this RCT, these programmes can be made available for all users of the app in the future.Trial registration number UMIN000038190; Pre-results.

The present study investigated the internal consistency reliability, construct validity, and item response characteristics of a newly developed Vietnamese version of the Kessler 6 (K6) scale among hospital nurses in Hanoi, Vietnam. The K6 was translated into the Vietnamese language following a standard procedure. A survey was conducted of nurses in a large general hospital in Hanoi, Vietnam, using a questionnaire including the Vietnamese K6, other scales (DASS21, health-related QOL, self-rated health, and psychosocial work environment), and questions about demographic variables. Internal consistency reliability (Cronbach's alpha coefficient) was calculated. A confirmatory factor analysis was conducted. Eleven hypotheses were tested (as Pearson's correlations with the K6) to assess the scale's construct validity. Item response theory (IRT) analysis was conducted to identify the item response characteristics. The Cronbach's alpha coefficient was 0.864. The explanatory and confirmatory factor analyses indicated a one-factor structure. Most hypotheses tested for construct validity were supported. IRT analysis indicated that response categories were located in order according to severity. K6 provided reliable information regarding higher levels of psychological distress. The findings suggest that the Vietnamese version of the K6 is a reliable and valid instrument to measure psychological distress among hospital nurses in Vietnam.

Study DesignWe established induced pluripotent stem cells (iPSCs) and neural stem/progenitor cells (NSPCs) from three newborns with spina bifida aperta (SBa) using clinically practical methods.PurposeWe aimed to develop stem cell lines derived from newborns with SBa for future therapeutic use.Overview of LiteratureSBa is a common congenital spinal cord abnormality that causes defects in neurological and urological functions. Stem cell transplantation therapies are predicted to provide beneficial effects for patients with SBa. However, the availability of appropriate cell sources is inadequate for clinical use because of their limited accessibility and expandability, as well as ethical issues.MethodsFibroblast cultures were established from small fragments of skin obtained from newborns with SBa during SBa repair surgery. The cultured cells were transfected with episomal plasmid vectors encoding reprogramming factors necessary for generating iPSCs. These cells were then differentiated into NSPCs by chemical compound treatment, and NSPCs were expanded using neurosphere technology.ResultsWe successfully generated iPSC lines from the neonatal dermal fibroblasts of three newborns with SBa. We confirmed that these lines exhibited the characteristics of human pluripotent stem cells. We successfully generated NSPCs from all SBa newborn-derived iPSCs with a combination of neural induction and neurosphere technology.ConclusionsWe successfully generated iPSCs and iPSC-NSPCs from surgical samples obtained from newborns with SBa with the goal of future clinical use in patients with SBa.

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. [ABSTRACT FROM AUTHOR]