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This study aimed to conduct a pilot randomized controlled trial (RCT) to examine the appropriateness and feasibility of a midwife-led cognitive behavioral therapy (CBT)-based, three-session program delivered remotely to pregnant women at risk for anxiety disorders. The study design was a pilot RCT. Outcome was the difference between the two groups in the change in generalized anxiety disorder-7 (GAD-7), Kessler6 (K6) and Edinberg Postnatal Depression Scale (EPDS) etc. Recruitment was conducted from August 2020 to July 2021 in clinics and web-based survey monitors in Japan, with follow-up through November 2021. This program involving 63 pregnant women were administered. Although the intervention was remote, a total of three sessions was completed during pregnancy. The change in GAD-7 scores from pre- to 1 month postpartum, was mean -1.77 in the intervention group and mean -0.97 in the control group, with a p-value of .521, indicating no significant difference between the two groups, although GAD-7 scores were lower in the intervention group. The change in K6 score from pre- to 1 month postpartum, was mean -3.55 in the intervention group and mean -1.62 in the control group, with a p-value of .168, indicating no significant difference between the two groups, although the intervention group showed a greater decrease. In particular, in primiparas, the change in GAD-7 scores in the intervention group was large, and some expressed a desire for a postpartum session, suggesting that a follow-up session after delivery may be effective. In multiparas, the control group showed an increase in both GAD-7 and K6 scores from late pregnancy to 1 month postpartum, while the intervention group showed a decrease in scores. The program was implemented using CBT conducted by midwife, anxiety decreased in primiparas. In future RCTs, it was suggested that additional postpartum sessions may be effective. UMIN Clinical trial registry ID: UMIN000040304.

Clinical and research interest is growing in mental health support for elite athletes, based on findings from epidemiological surveys conducted in Australia, the United States, and European countries. However, little is known about the mental health status of elite athletes in Asia, including Japan. In the current study, we examine the prevalence of mental health problems and suicidal ideation and its risk factors in Japan Rugby Top League players. We analyze anonymous web-based self-reported data from 251 currently competing Japan Rugby Top League male players. During the off-season from December 2019 to January 2020, data on anxiety and depression symptoms were collected using the Japanese version of the 6-item Kessler-6. Suicidal ideation was assessed using the Baron Depression Screener for Athletes. Among the players, 81 players (32.3%) had experienced symptoms of mild anxiety and depression during the previous 30 days, while 12 (4.8%) and 13 (5.2%) had suffered from moderate and severe symptoms, respectively. Nineteen athletes (7.6%) reported that they had experienced suicidal ideation during the previous 2 weeks. Players with mental health problems experienced more events in competitions and daily life, including reduced subjective performance, missing opportunities to play during the last season, changes in health condition, and thinking about a career after retirement, compared with players without such problems. Mental health issues in Japan Rugby Top League players, as elite athletes, may be common, and research and practice development is expected in the near future.

The Overall Depression Severity and Impairment Scale (ODSIS) is a brief, five-item measure for assessing the frequency and intensity of depressive symptoms, as well as functional impairments in pleasurable activities, work or school, and interpersonal relationships due to depression. Although this scale is expected to be useful in various psychiatric and mental health settings, the reliability, validity, and interpretability have not yet been fully examined. This study was designed to examine the reliability, factorial, convergent, and discriminant validity of a Japanese version of the ODSIS, as well as its ability to distinguish between individuals with and without a major depressive disorder diagnosis. From a pool of registrants at an internet survey company, 2830 non-clinical and clinical participants were selected randomly (619 with major depressive disorder, 619 with panic disorder, 576 with social anxiety disorder, 645 with obsessive-compulsive disorder, and 371 non-clinical panelists). Participants were asked to respond to the ODSIS and conventional measures of depression, functional impairment, anxiety, neuroticism, satisfaction with life, and emotion regulation. Exploratory and confirmatory factor analysis of three split subsamples indicated the unidimensional factor structure of ODSIS. Multi-group confirmatory factor analysis showed invariance of factor loadings between non-clinical and clinical subsamples. The ODSIS also showed excellent internal consistency and test-retest intraclass correlation coefficients. Convergence and discriminance of the ODSIS with various measures were in line with our expectations. Receiver operating characteristic curve analyses showed that the ODSIS was able to detect a major depressive syndrome accurately. This study supports the reliability and validity of ODSIS in a non-western population, which can be interpreted as demonstrating cross-cultural validity.

Globally increasing clinical and research interests are driving a movement to promote understanding and practice of mental health in elite athletes. However, few studies have yet addressed this issue. This study aims to describe the association of the intention to seek help with mental health knowledge and stigma and the severity of depressive symptoms in Japan Rugby Top League players. As a target population, we studied 233 Japan Rugby Top League male players (25-29 years = 123 [52.8%]), who were born in Japan, using a cross-sectional design. Surveys were conducted using anonymous, web-based self-administered questionnaires. Structural equation modelling was performed to evaluate the hypothesis of an interrelationship between mental health knowledge, stigma, and severity of depressive symptoms as factors influencing the intention to seek help. Players with more severe depressive symptoms were more reluctant to seek help from others (β = - 0.20, p = 0.03). Players with greater knowledge about mental health tended to have less stigma toward others with mental health problems (β = 0.13, p = 0.049), but tended not to seek help with their own mental health problems. Rugby players in need of mental health support, even with greater knowledge, tend not to seek help from others, while having less stigma toward people with mental health problems. Rugby players might require approaches other than a knowledge-based educational approach to encourage them to seek help.

Background Marital satisfaction is a key determinant of maternal mental health during the perinatal period. Identifying psychosocial factors associated with changes in marital satisfaction can help inform early preventive interventions. Methods This longitudinal study examined associations between psychosocial factors measured during pregnancy and changes in marital satisfaction from pregnancy to 52 weeks postpartum. Participants were 752 pregnant women in Japan (mean age = 32.0 ± 4.3 years) who completed online surveys during pregnancy and at 52 weeks postpartum. Marital satisfaction was assessed using the Quality of Marriage Index (QMI), a validated measure of relationship satisfaction, and categorized into three groups based on QMI score differences: improved (≥ 1-point increase), unchanged (0-point difference), and worsened (≥ 1-point decrease). Psychosocial variables included depressive symptoms assessed by the Edinburgh Postnatal Depression Scale (EPDS), household income, perceived burden of household chores and childcare, parity, and perceived family support. Multinomial logistic regression was used to examine associations between these variables and changes in marital satisfaction. Results Higher levels of depressive symptoms during pregnancy, as measured by the EPDS, were significantly associated with worsening marital satisfaction after childbirth (RRR = 2.38, 95% CI: 1.30–4.37, p  = 0.005). Lower household income also predicted a decline in satisfaction (RRR = 0.999, 95% CI: 0.999–1.00, p  = 0.017). Participants who reported extremely long hours of household chores and childcare were less likely to experience improved satisfaction (RRR = 0.15, 95% CI: 0.04–0.65, p  = 0.011). First-time childbirth was negatively associated with improvement (RRR = 0.41, 95% CI: 0.20–0.87, p  = 0.019). Higher levels of perceived family support were also associated with less improvement in marital satisfaction (RRR = 0.89, 95% CI: 0.80–0.98, p  = 0.017). Conclusion Psychosocial factors during pregnancy, including depressive symptoms, economic hardship, and perceived domestic burden, were significantly associated with subsequent changes in marital satisfaction. These findings underscore the importance of early mental health screening and supportive interventions for expectant couples.

Objectives: The primary objective is to compare the prevalence of mental health problems, including psychological distress, anxiety and depressive symptoms in Japan Rugby Top League players in the new life with COVID-19 with those evaluated before COVID-19. Methods: An observational comparative web-based cross-sectional study was employed for Japan Rugby Top League players. We compared the data from 220 Japanese and 7 foreign players during the new life with COVID-19 with the data from before COVID-19, which was obtained from 233 Japanese and 18 foreign players. We measured anxiety and depression symptoms with the validated Kessler-6, which has been widely used in clinical and research settings among different populations. To investigate the distribution of K6 score and whether there are discrete clusters or not, we conducted the two-step cluster analysis. Results: In the new life with COVID-19, 15.0% of players reported mild symptoms, which was significantly lower than the 32.3% of players before COVID-19. The prevalence of moderate and severe symptoms was 6.7 and 3.5%, respectively, in the group during the new life with the COVID-19, and 4.8 and 5.2% in the pre-COVID-19 group, with no significant difference. A two-step cluster analysis supported the existence of these two qualitatively different clusters in both groups. Conclusions: With the spread of new lifestyles related to COVID-19, some rugby players may have improved mental health status due to changes in their daily living environment. Such environmental adjustments alone may not have been sufficient to change the mental health status of others. Rugby players or their teams may require mental health professionals and systems that ensure rest, adjust the environment, and sustainably provide more professional care.

Background:The clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it.Objective:We aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression.Methods:This is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months.Results:Participant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023.Conclusions:This study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study.Trial Registration:Japan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481International Registered Report Identifier (IRRID):DERR1-10.2196/49698

The prevalence of mental health disorders among children in Japan has increased rapidly, and these children often show depressive symptoms and reduced quality of life (QOL). We previously developed a smartphone-based self-monitoring app to deliver cognitive behavioral therapy (CBT), implemented it in healthy children, and reported its effectiveness for health promotion. This study aims to examine the usefulness of the CBT app for improvement in depressive symptoms and QOL in children with mental health disorders. The participants were 115 children with mental health disorders (eg, school refusal, orthostatic hypotension, eating disorders, developmental disorders, among others) and aged 12-18 years. The CBT app-based program comprised 1 week of psychoeducation followed by 1 week of self-monitoring. After reading story-like scenarios, participants created a self-monitoring sheet with 5 panels: events, thoughts, feelings, body responses, and actions. All participants received regular mental health care from physicians in addition to the app-based program. To evaluate the participants' depressive symptoms and QOL, Patient Health Questionnaire for Adolescents (PHQ-9A), Depression Self-Rating Scale for Children (DSRS-C), and Pediatric Quality of Life Inventory (PedsQL) were measured at the beginning of the intervention, and at 2 and 6 months thereafter. Questionnaire for Triage and Assessment with 30 items (QTA30), and Rosenberg Self-Esteem Scale (RSES) were also used to measure their health and self-esteem. Participants were divided into 4 groups on the basis of the PHQ-9A score (above or below the cutoff; PHQ-9A≥5 or PHQ-9A<5) and completion or noncompletion of the CBT app-based program (app [+] or app [-]). The primary outcome was improvement in the DSRS-C score, and secondary outcomes were improvement in other psychometric scales including PedsQL, QTA30, and RSE. A paired-samples t test was used for statistical analysis. The Medical Ethics Committee of Fukuoka University Faculty of Medicine (approval U22-05-002) approved the study design. There were 48, 18, 18, and 7 participants in the PHQ-9A≥5 app (+), PHQ-9A≥5 app (-), PHQ-9A<5 app (+), and PHQ-9A<5 app (-) groups, respectively. A total of 24 participants dropped out. No improvement in the DSRS-C score was observed in all groups. However, PedsQL scores improved significantly at 2 and 6 months in the PHQ-9A<5 app (+) group (t17=6.62; P<.001 and t17=6.11; P<.001, respectively). There was a significant positive correlation between the PHQ-9A scores and the number of self-monitoring sheets completed. The CBT app was useful for improving PedsQL scores of children with mental health disorders. However, a higher-intensity CBT program is necessary for more severely depressed children.

Adolescent health promotion is important in preventing risk behaviors and improving mental health. Health promotion during adolescence has been shown to contribute to the prevention of late onset of the mental health disease. However, scalable interventions have not been established yet. This study was designed to test the efficacy of two adolescent health promotion interventions: a well-care visit (WCV) with a risk assessment interview and counseling and self-monitoring with a smartphone cognitive behavioral therapy (CBT) app. Our hypothesis was that participants who had received both WCV and the CBT app would have better outcomes than those who had received only WCV or those who had not received any intervention. We conducted a prospective multi-institutional randomized controlled trial. Participants were 217 adolescents aged 13-18 years. They were randomly divided into two intervention groups (WCV group and WCV with CBT app group) and a nonintervention group. WCV comprised a standardized physical examination along with a structured interview and counseling for youth risk assessment, which was designed with reference to the Guideline for Health Supervision of Adolescents of Bright Futures. A smartphone-based CBT program was developed based on the CBT approach. The CBT app comprised a 1-week psychoeducation component and a 1-week self-monitoring component. During the CBT program, participants created several self-monitoring sheets based on the CBT model with five window panels: event, thoughts, feelings, body response, and actions. The primary outcome was the change in scores for depressive symptoms. Secondary outcomes included changes in scores for self-esteem, quality of life, self-monitoring, and an adolescent health promotion scale. These outcomes were evaluated at baseline and at 1, 2, and 4 months after baseline. The exploratory outcome was the presence of suicidal ideation during the observation period. Intervention effects were estimated using mixed effect models. In total, 94% (204/217) of the participants completed the 4-month evaluation. Both intervention groups showed a significant effect in the form of reduced scores for depressive symptoms at 1 month in high school students; however, these effects were not observed at 2 and 4 months. The intervention effect was significantly more predominant in those scoring above cutoff for depressive symptoms. There was significantly less suicidal ideation in the intervention groups. As for secondary outcomes, there was significant increase in health promotion scale scores at the 4-month follow-up among junior high school students in the WCV group. Moreover, the CBT app was significantly effective in terms of obtaining self-monitoring skills and reducing depressive symptoms. Although adolescent health promotion interventions may have short-term benefits, the frequency of WCV and further revision of the CBT app should be considered to evaluate long-term effectiveness. University Hospital Medical Information Network Clinical Trials Registry UMIN 000036343; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041246.

Background Chronic pain is a major health problem, and cognitive behavioral therapy (CBT) is its recommended treatment; however, efforts to develop CBT programs for chronic pain and assess their feasibility are remarkably delayed in Asia. Therefore, we conducted this pilot study to develop a basic individualized CBT for chronic pain (CBT-CP) and assessed its feasibility for use in Japan. Methods Our study was an open-labeled before–after trial without a control group conducted cooperatively in five Japanese tertiary care hospitals. Of 24 outpatients, 15, age 20–80, who experienced chronic pain for at least three months were eligible. They underwent an eight-session CBT-CP consisting of relaxation via a breathing method and progressive muscle relaxation, behavioral modification via activity pacing, and cognitive modification via cognitive reconstruction. The EuroQol five-dimensional questionnaire five level (EQ5D-5 L) assessment as the primary outcome and quality of life (QOL), pain severity, disability, catastrophizing, self-efficacy, and depressive symptoms as secondary outcomes were measured using self-administered questionnaires at baseline, post-treatment, and 3-month follow-up. Intention-to-treat analyses were conducted. Results Effect size for EQ5D-5 L score was medium from baseline to post-treatment (Hedge’s g  = − 0.72, 90% confidence interval = − 1.38 to − 0.05) and up to the 3-month follow-up ( g  = − 0.60, CI = − 1.22 to 0.02). Effect sizes for mental and role/social QOL, disability, catastrophizing, self-efficacy, and depressive symptoms were medium to large, although those for pain severity and physical QOL were small. The dropout rate was acceptably low at 14%. No severe adverse events occurred. Conclusion The findings suggest that CBT-CP warrants a randomized controlled trial in Japan. Trial registration University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000020880 . Registered on 04 February 2016.