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.

Multifaceted ORganizational InterventiONs (M-ORION) project for prevention of depression and anxiety among workers: study protocol for a five-arm cluster randomized controlled trial.

BACKGROUND: Depression and anxiety are the most common mental health issues experienced by workers. Although organizational intervention has been extensively evaluated as a primary prevention of depression and anxiety, the corresponding scientific evidence remains limited because of the lack of cluster randomized controlled trials (cRCT) and failure to detect organizational-level effects. Therefore, the present study aims to assess the preventive effects of four types of interventions on depression and anxiety among workers in an open, five-arm, parallel-group cRCT. METHODS: Overall, 140 worksites and 18,200 nested employees will be recruited from September 2023. The eligible worksites will be randomly assigned to each of the five arms, and programs will be offered for 6-12 months. The five arms are 1) psychoeducation for workers, 2) psychoeducation for supervisors, 3) work environment improvement, 4) physical activity promotion, and 5) active control. The primary outcomes of interest are depression and anxiety. We will also assess psychosocial factors at work, work engagement, health-related quality of life, well-being, economic outcomes, physiological outcomes of health checkups, cortisol levels extracted from fingernails, and indices representing the process and implementation outcomes, including program completion rates. Follow-up surveys will be conducted at 6, 12, and 18 months from baseline, and the primary endpoint is set at the 6-month follow-up. Repeated-measures multi-level mixed modeling will be used to evaluate the effect of each intervention compared with the control. ETHICS AND DISSEMINATION: The study protocol was approved by the Research Ethics Committee of the Kitasato University Medical Ethics Organization (C22-082). The results and findings of this study will be published in a scientific journal and disseminated to companies that participate in the study. TRIAL REGISTRATION NUMBER: UMIN000050949.

The association between team job crafting and work engagement among nurses: a prospective cohort study.

BACKGROUND: Team-level job crafting has been put forward as a method to promote nurses' mental health. However, a longitudinal association is unclear. Therefore, the objective of this study was to investigate the association between team job crafting at baseline and work engagement, work performance, psychological distress, and intention to leave at three-month and six-month follow-ups among Japanese hospital nurses. Also, whether an increase in the team job crafting during 3 or 6 months was associated with an increase in the work engagement during 3 or 6 months of individual nurses was examined. METHODS: A multilevel prospective cohort study was conducted. Data were collected from nurses of five hospitals in Japan at baseline (T1) and follow-ups at 3-months (T2) and 6-months (T3). A total of 2,478 nurses were included. The team job crafting scale for nurses and its three subscales were measured for the independent variables. Ward-means were used as ward-level variables. The dependent variables were work engagement, work performance, psychological distress, and intention to leave. Hierarchical Linear Modeling (HLM) was used to examine the multilevel association. The study protocol was registered at the UMIN Clinical Trials Registry (ID = UMIN000047810) (May 22, 2022). RESULTS: A total of 460 nurses completed the T1 survey (response rate = 18.6%), and data from 391 nurses nested in 30 wards were included in the analyses. The intraclass correlation coefficients (ICCs) at T1 were 0.02 for work engagement and 0.07 for team job crafting. The HLM revealed that ward-level team job crafting at T1 was not significantly associated with work engagement, work performance, psychological distress, and intention to leave at T2 or T3. The ward-level change (T3-T1) of "crafting for the task considering the team's growth" (subscale for team job crafting) was significantly and positively associated with the change (T3-T1) in work engagement. CONCLUSIONS: Ward-level team job crafting at baseline did not predict nurses' work engagement, work performance, psychological distress, or intention to leave at a three-month or six-month follow-up. The impact of ward-level team job crafting may attenuate over several months.

What digital health technology types are used in mental health prevention and intervention? Review of systematic reviews for systematization of technologies.

Digital health technology has been widely applied to mental health interventions worldwide. Using digital phenotyping to identify an individual's mental health status has become particularly important. However, many technologies other than digital phenotyping are expected to become more prevalent in the future. The systematization of these technologies is necessary to accurately identify trends in mental health interventions. However, no consensus on the technical classification of digital health technologies for mental health interventions has emerged. Thus, we conducted a review of systematic review articles on the application of digital health technologies in mental health while attempting to systematize the technology using the Delphi method. To identify technologies used in digital phenotyping and other digital technologies, we included 4 systematic review articles that met the inclusion criteria, and an additional 8 review articles, using a snowballing approach, were incorporated into the comprehensive review. Based on the review results, experts from various disciplines participated in the Delphi process and agreed on the following 11 technical categories for mental health interventions: heart rate estimation, exercise or physical activity, sleep estimation, contactless heart rate/pulse wave estimation, voice and emotion analysis, self-care/cognitive behavioral therapy/mindfulness, dietary management, psychological safety, communication robots, avatar/metaverse devices, and brain wave devices. The categories we defined intentionally included technologies that are expected to become widely used in the future. Therefore, we believe these 11 categories are socially implementable and useful for mental health interventions.

Corrigendum: Effects of a job crafting intervention program on work engagement among Japanese employees: A randomized controlled trial.

[This corrects the article DOI: 10.3389/fpsyg.2020.00235.].

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).

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.

Adolescent cannabis use and the later onset of bipolar disorder: protocol for a systematic review and meta-analysis of prospective cohort studies.

BACKGROUND: Cannabis is used by adolescents worldwide. Adolescents are more susceptible to the psychological effects of cannabis because their brains are still developing. Cannabis use in adolescents has been reportedly associated with later onset of bipolar disorder. AIMS: The purpose of this study is to systematically review and analyze longitudinal prospective cohort studies of cannabis use during adolescence and evaluate the risk of developing bipolar disorder. METHODS: We defined the participants, exposures, comparisons, and outcomes (PECO) as follows: (P) adolescents in the 10-19-year age group at the baseline survey; (E) cannabis use at least once during lifetime; (C) never-used cannabis over lifetime; and (O) the onset of bipolar disorder. A systematic search for published prospective cohort studies will be conducted by using the following electronic databases: PubMed, EMBASE, PsycINFO, and Japan Medical Abstracts Society. The quality assessment will be performed by using Risk Of Bias In Non-randomized Studies - of Interventions. Meta-analysis will be done if the included studies that exist are more than three. Heterogeneity will be assessed using Cochran's Q test and I2 . Funnel plots and Egger's test will be done to assess publication bias. DISCUSSION: This study will clarify the association between adolescent cannabis use and the subsequent development of bipolar disorder, which could be useful for future research directions and policy making.

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).

Effect of stress management based on cognitive-behavioural therapy on nurses as a universal prevention in the workplace: a systematic review and meta-analysis protocol.

INTRODUCTION: The mental health status of nurses affects not only their well-being but also the organisational outcomes and the quality of patient care. Hence, stress management strategies are critical as a universal prevention measure that address an entire population and are not directed at a specific risk group to maintain nurses' mental health in the workplace. No systematic review or meta-analysis has been conducted to evaluate the effect of cognitive-behavioural therapy (CBT) that specifically focuses on universal prevention. Therefore, the aim of this study is to examine the effectiveness that is reported in published randomised controlled trial (RCT) studies. METHODS AND ANALYSIS: This systematic review and meta-analysis will analyse published studies selected from electronic databases (ie, Cochrane Central Register of Controlled Trials, PubMed, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, PsycARTICLES, Web of Science and the Japan Medical Abstracts Society). The inclusion criteria for studies are that they (1) were conducted to assess the effect of CBT on the mental health of nurses as a universal prevention, (2) used an RCT design and (3) provided sufficient results (sample sizes, means and SD) to estimate the pooled effect sizes with 95% CIs. Studies will be excluded if they only targeted nurses who had been screened as being at high risk in terms of their mental health and indicated that they required the prevention. The methodological quality of the included studies will be assessed using the Cochrane Collaboration's risk of bias tool. ETHICS AND DISSEMINATION: Ethical approval is not required because this study is based on information obtained from previous studies. The results and findings of this study will be submitted for publication in a peer-reviewed international scientific journal. Results from this study will be helpful when implementing CBT strategies for nurses as a universal preventative measure in the workplace and for managing stress-related outcomes. PROSPERO REGISTRATION NUMBER: CRD42020152837.

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.