佐々木 洋平

BACKGROUND: This study aimed to evaluate the association of COVID-19 preventive behavior and job-related stress with sleep quality among healthcare workers (HCWs). We conducted a cross-sectional survey using a questionnaire at the National Center of Neurology and Psychiatry, Tokyo, Japan. METHODS: A total of 586 participants who completed the questionnaire were eligible for the study. The Pittsburgh Sleep Quality Index was used to evaluate sleep quality. We examined the level of engagement between poor sleep and COVID-19-related infection preventive behaviors, such as avoiding closed spaces, crowded places, and close contact (three Cs), a distance of at least one meter from others, wearing a face mask regularly, washing hands regularly, and working remotely, as well as job-related stress in the work environment, exposure to patients, potential risk of infection, fear of infecting others, need for social confinement, and financial instability. We conducted a hierarchical logistic regression analysis to examine the relationship between poor sleep and COVID-19 preventive behavior, job-related stress, and other covariates, including age, sex, and the Kessler Psychological Distress Scale (K6), which was used to measure non-specific psychological distress. RESULTS: Poor sleep was observed in 223 (38.1%) participants. Adherence to COVID-19 preventive measures was relatively high: 84.1% of participants answered "always" for wearing a face mask regularly and 83.4% for washing hands regularly. In the multivariate logistic regression analysis, stress in the work environment (odds ratio [OR] = 2.09, 95% confidence interval [CI], 1.37-3.20; p < 0.001), financial instability (OR = 1.73, 95% CI, 1.12-2.67; p < 0.05), and low adherence to working remotely (OR = 1.65, 95% CI, 1.06-2.57; p < 0.05) were independently and significantly associated with poor sleep after controlling for the covariates. CONCLUSIONS: One year into the COVID-19 pandemic, the poor sleep rates of HCWs remained high. These results emphasize the need to protect HCWs from work environment stress and financial concerns.

BACKGROUND: Recent studies have shown an association between psychological distress and emotion malleability beliefs, meaning mindsets about whether one's emotions are fixed or changeable. However, most studies have not examined the association between these beliefs and sociodemographic factors. METHODS: A nationwide cross-sectional Internet survey of residents of Japan aged 15-79 years was conducted using sampling weights for national estimates to investigate the association between emotion malleability beliefs and sociodemographic factors and between fixed beliefs and severe psychological distress (SPD). SPD was defined as a Kessler 6 Scale score of ≥13. Adjusted odds ratios for SPD were calculated considering potential confounders. Further analyses were stratified by sex, age and presence of any psychiatric disorder. RESULTS: The analysis included 23,142 participants (female, 48.64%). Fixed beliefs were associated with female sex, age < 45 years, and presence of psychiatric disorders. These beliefs were associated with SPD, and additional analysis showed stronger associations with SPD among female respondents, respondents aged 45-59 years, and those aged ≥60 years. CONCLUSION: Results indicate that female sex, age < 45 years, and current mental disorders were associated with fixed emotion malleability beliefs. Associations between fixed emotion malleability beliefs and SPD were particularly strong among female respondents and people aged ≥45 years compared with the general population. Our study extends the association between emotion malleability beliefs and psychological health to the general population. Future studies should explore mechanisms underlying individual differences in emotion beliefs.

Previous cross-sectional studies showed that COVID-19-related discrimination against healthcare workers was linked to depression. However, no study has examined the longitudinal association that allows causal interpretations. This prospective cohort study aimed to examine whether COVID-19-related discrimination at baseline is associated with depression and suicidal ideation several months later. Data were collected from October 2020 to July 2021. Multivariable logistic regression was performed. Fixed effects models were used to control for the effect of hospitals (Level 2 variable). Adjustments also included age, sex, living alone, alcohol consumption, exercise, BMI, working hours, comorbidity, and frontline worker status (Level 1 variables). Multiple sensitivity analyses were conducted to examine if the results substantially changed and were robust to unmeasured confounding. Multiple imputation for missing data was conducted via chained equations. As the final sample, 2862 healthcare workers without depression at baseline were studied. A total of 269 individuals (9.4%) experienced COVID-19-related discrimination. Depression was suggested in 205 participants (7.2%), and suicidal ideation in 108 participants (3.8%). In the adjusted models, COVID-19-related discrimination was significantly associated with subsequent depression (OR = 2.18, 95% CI = 1.39 to 2.90) and suicidal ideation (OR = 2.07, 95% CI = 1.22 to 3.50). Multiple sensitivity analyses verified the results. COVID-19-related discrimination results in depression and suicidal ideation in healthcare workers. Interventions to prevent such discrimination against healthcare workers, e.g., anti-discrimination campaigns, are crucial during the COVID-19 pandemic.

PURPOSE: Major depression is a heterogeneous disorder. Therefore, careful evaluation and comprehensive assessment are crucial elements for achieving remission. Personality traits influence prognosis and treatment outcomes, but there is not enough evidence on the association between personality traits and sustained remission (SR). Hence, the present study aimed to evaluate the relationship between personality traits and SR among patients with major depression. PATIENTS AND METHODS: The 12-month prospective study evaluated 77 patients diagnosed with major depressive disorder. All patients underwent a comprehensive assessment, including the Temperament and Personality Questionnaire (T&P) at baseline, and depression severity was measured at baseline as well as six and 12 months. SR was defined as remission (the GRID-Hamilton Depression Rating Scale [GRID-HAMD17] score ≦ 7) at both the 6- and 12-month follow-up. We compared eight T&P construct scores at baseline between the SR and non-SR groups. Multivariable logistic regression analyses were performed to determine the T&P personality traits related to SR. RESULTS: Patients who achieved SR had a lower T&P personal reserve and lower T&P rejection sensitivity. Further, lower scores on the T&P personal reserve trait were independently associated with higher rates of SR among patients with major depression. Patients who achieved SR had a shorter duration of the current depressive episode and milder severity of depression at baseline. CONCLUSION: A lower level of personal reserve predicted a higher probability of SR in the treatment of depression. Extended observations in naturalistic follow-up settings with larger sample sizes are required to better understand the personality traits affecting SR in patients with depression.

Abstract Background Discrimination has been identified as an important determinant of negative mental health outcomes. This study determined the association between the experience of COVID-19-related discrimination and psychological distress among healthcare workers (HCWs) in Japan. Methods This cross-sectional study conducted a health survey among 5,703 HCWs of six national medical and research centers in Japan from October 2020 to March 2021. COVID-19-related discrimination was defined either when participants or their family members were badmouthed or when they felt discriminated against in some way. We used the Kessler Psychological Distress Scale (K6) to assess the presence of severe psychological distress (≥13 points). We used logistic regression models to examine the association between discrimination and psychological distress. We also identified job-related factors associated with discrimination. Results Of the participants, 484 (8.4%) reported COVID-19-related discrimination and 486 (8.5%) had severe psychological distress. HCWs who were female vs. male (odds ratio [OR]=1.41, 95% confidence interval [CI]=1.28-1.55), had high vs. low viral exposure (OR=2.31, 95%CI=1.81-2.93), and worked for more than 10 hours/day vs. &lt;8 hours/day (OR=1.42, 95%CI=1.35-1.49) were more likely to have experienced COVID-19-related discrimination. The OR (95%CI) of severe psychological distress was 1.83 (1.29-2.59) among those who experienced discrimination. The analysis was stratified by sociodemographic and job-related factors and the associations trended in the same direction across subgroups. Conclusion Experience of COVID-19-related discrimination was associated with severe psychological distress among HCWs. During the pandemic, effective measures should be taken to prevent the development of negative mental health outcomes in HCWs who experience discrimination.

Background Social cognitive impairments adversely affect social functioning (e.g., employment status) in patients with schizophrenia. Although pharmacological interventions have been suggested to provide some benefits on social cognition, little information is available on the comparative efficacy of pharmacotherapy. Thus, the aim of this planned systematic review and network meta-analysis is to perform a quantitative comparison of the effects of various psychotropic drugs, including supplements, on social cognition disturbances of schizophrenia. Methods The literature search will be carried out using the PubMed, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, ClinicalTrials.gov, and International Clinical Trials Registry Platform databases from inception onward. Randomized controlled trials that examined the efficacy of drugs in social cognitive disturbances will be included, based on the most recent studies and the broader literature than previously searched. This protocol defines a priori the methods that will be used for study selection, data collection, quality assessment, and statistical syntheses. Discussion The findings this work are expected to help promote the development of better therapeutics of social cognitive impairments in schizophrenia and related psychiatric conditions. Systematic Review Registration [www.crd.york.ac.uk/prospero], identifier [CRD42021293224].

People have beliefs about the unacceptability of the expression and experience of negative emotions. These beliefs affect psychological health and can have a negative effect on the treatment and symptoms of people with mental disorders and medically unexplained symptoms. This study aimed to develop a Japanese version of the Beliefs about Emotions Scale (BES-J) and evaluate its reliability and validity. In an online survey, participants with fibromyalgia (n = 226) and healthy controls (n = 184) completed the BES-J and questionnaires concerning perfectionism, dysfunctional attitudes, depression, anxiety, pain, disability, well-being, interdependent happiness, and loneliness. The results of the principal component analysis showed that the BES-J comprised a one-factor structure, identical to the original. The BES-J had good internal consistency (.89) and showed a significant correlation with the questionnaires. The BES-J showed good internal reliability, concurrent validity, and test–retest reliability. The present study suggests that the Japanese version of the BES is appropriate for use with Japanese speakers.

INTRODUCTION: Few people can access psychotherapy for irritable bowel syndrome (IBS). Group cognitive-behavioral therapy (GCBT) may be efficient, but the evidence for its efficacy is weak and limited. We aimed to assess the efficacy and safety of GCBT with interoceptive exposure (GCBT-IE), a novel form of GCBT for drug-refractory IBS. METHODS: A single-center, open-label, randomized, controlled trial was conducted in Japan among people aged 18-75 years with moderate-to-severe drug-refractory IBS. Participants were stratified by IBS severity and allocated 1:1 to 10-week GCBT-IE or waiting list (WL) in a blockwise randomization by independent staff. Both arms practiced self-monitoring and received treatment as usual. Multiple primary outcomes were changes from baseline to week 13 in the IBS Symptom Severity Score and the IBS Quality of Life Measure (IBS-QOL), assessed in the intention-to-treat sample. RESULTS: A total of 114 people with drug-refractory IBS were randomized to GCBT-IE (n = 54) or WL (n = 60). Forty-nine participants (90.7%) in the GCBT-IE arm and 58 (96.7%) in the WL arm completed the week 13 assessment. Participants in the GCBT-IE arm reported greater improvements in both IBS symptom severity and quality of life compared with the WL arm, with -115.8 vs -29.7 on the IBS Symptom Severity Score (a difference of -86.1, 95% confidence interval -117.3 to -55.0), and 20.1 vs -0.2 on the IBS-QOL (a difference of 20.3, 95% confidence interval 15.2-25.3), respectively. Six unexpected serious adverse events were reported but were judged as unrelated to the interventions. DISCUSSION: GCBT-IE is an efficacious, safe, and efficient treatment option for people with drug-refractory IBS.

BACKGROUND: Despite the importance of Beck's theoretical cognitive model of psychopathology, the neural mechanisms underlying future thinking in cognitive behavioral therapy (CBT) remain elusive. Recent neuroimaging studies have shown that the function of the frontopolar cortex (Brodmann area 10 [BA10]) is associated with future thinking. We hypothesized that, compared with unstructured psychotherapy (talking control: TC), CBT may involve different neural responses in BA10 associated with future thinking. METHODS: This randomized clinical trial included 38 adult patients with moderate-to-severe major depressive disorder who underwent up to 16 weeks of CBT or TC with a 6-month follow-up period. We evaluated changes in BA10 activation during distant future thinking using functional magnetic resonance imaging with a future-thinking task. We assessed frontal neurocognitive function and clinical symptoms at baseline and post-treatment. Depression severity and automatic thoughts were assessed at the 6-month follow-up. RESULTS: We found decreased activation in the frontopolar cortex during distant future thinking after CBT (t = 3.00, df=15, p = 0.009) and no changes after TC. Further, the reduction in BA10 activity significantly correlated with changes in frontal cognitive function after the treatment (r = 0.48, p = 0.007), and in positive automatic thought after 6 months of treatments (r = 0.39; p = 0.03). LIMITATIONS: Relatively small sample size and homogenous clinical profile could limit the generalizability. Patients received pharmacotherapy including antidepressant. CONCLUSIONS: CBT appears to improve frontopolar cortex function during future thinking in a manner distinct from TC. Larger clinical trials are necessary to provide firm evidence whether BA10 activity may serve as a neuro-marker for monitoring successful depression treatment with CBT.

Background Augmented mindfulness-based cognitive therapy (MBCT) with treatment as usual (mainly pharmacotherapy) is reported to be effective after treatment for anxiety disorders. However, whether its effectiveness persists in the long term is unclear. Objective This study aims to examine the feasibility, acceptability, and effectiveness of a follow-up program by conducting a feasibility randomized controlled trial (RCT) that compares augmented MBCT with follow-up sessions and that without follow-up sessions in preparation for a definitive RCT. Methods The study involves an 8-week MBCT with a 10-month follow-up. Patients aged 20 to 65 years who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for panic disorder, agoraphobia, or social anxiety disorder, which is not remitted with usual treatment for at least 4 weeks, will be included in the study and randomly allocated to receive augmented MBCT with follow-up sessions or augmented MBCT without follow-up sessions. For this feasibility RCT, the primary outcomes are (1) study inclusion rate, (2) dropout rate, (3) attendance rate, and (4) mean and standard deviation of several clinical measures at 8 weeks and 5, 8, and 12 months. Results We started recruiting participants in January 2020, and 43 participants have been enrolled up to January 2021. The study is ongoing, and data collection will be completed by May 2022. Conclusions This study is novel in terms of its design, which compares augmented MBCT with and without follow-up sessions. The limitations of the trial are as follows: (1) mixed participants in terms of the delivery mode of the intervention, and (2) lack of a pharmacotherapy-alone arm. Owing to its novelty and significance, this study will provide fruitful knowledge for future definitive RCTs. Trial Registration UMIN Clinical Trials Registry UMIN000038626; https://tinyurl.com/2p9dtxzh International Registered Report Identifier (IRRID) DERR1-10.2196/33776

In schizophrenia, social cognitive impairment is considered one of the greatest obstacles to social participation. Although numerous measures have been developed to assess social cognition, only a limited number of them have become available in Japan. We are therefore planning this evaluation study for social cognition measures in Japan (ESCoM) to confirm their psychometric characteristics and to promote research focused on social cognition. Participants in the cross-sectional observational study will be 140 patients with schizophrenia recruited from three Japanese facilities and 70 healthy individuals. In our primary analysis, we will calculate several psychometric indicators with a focus on whether they can independently predict social functioning. In secondary analyses, we will assess the reliability and validity of the Japanese translations of each measure and conduct an exploratory investigation of patient background, psychiatric symptoms, defeatist performance belief, and gut microbiota as determinants of social cognition. The protocol for this study is registered in UMIN-CTR, unique ID UMIN000043777.

The fear of cancer recurrence (FCR) is the most common and most severe unmet need among cancer survivors. Safe treatments for the FCR that are easily disseminated are greatly needed. Our primary aim is a preliminary evaluation of the efficacy and effect size of perilla oil, which is rich in omega-3 fatty acids, and Bifidobacterium, a probiotic, on FCR in breast cancer survivors after the completion of chemotherapy. This study has been planned as an exploratory clinical study (phase II) and will be conducted as a three-arm, 12-week parallel group, masked-rater randomized controlled trial. Fifteen participants will be randomized with 1:1:1 allocation to receive Bifidobacterium plus perilla oil, Bifidobacterium alone, or no intervention (control). Interventions will end within 12 weeks after the random allocation of each participant. The participants will be outpatients with invasive breast cancer aged 20 years or older whose chemotherapy was completed at least 6 months before registration; hormone therapy may be ongoing. The primary outcome will be severity of FCR at 12 weeks assessed by masked raters using the 4-item Concerns about Recurrence Scale concerning overall fear of recurrence. The study protocol for the current study is registered in the Japan Registry of Clinical Trials (jRCTs031200029).

Social cognition is strongly linked to social functioning outcomes, making it a promising treatment target. Because social cognition measures tend to be sensitive to linguistic and cultural differences, existing measures should be evaluated based on their relevance for Japanese populations. We aimed to establish an expert consensus on the use of social cognition measures in Japanese populations to provide grounds for clinical use and future treatment development. We assembled a panel of experts in the fields of schizophrenia, social psychology, social neuroscience, and developmental disorders. The panel engaged in a modified Delphi process to (1) affirm expert consensus on the definition of social cognition and its constituent domains, (2) determine criteria to evaluate measures, and (3) identify measures appropriate for Japanese patients with a view toward future quantitative research. Through two online voting rounds and two online video conferences, the panel agreed upon a definition and four-domain framework for social cognition consistent with recent literature. Evaluation criteria for measures included feasibility and tolerability, reliability, clinical effectiveness, validity, and international comparability. The panel finally identified nine promising measures, including one task originally developed in Japan. In conclusion, we established an expert consensus on key discussion points in social cognition and arrived at an expert-selected set of measures. We hope that this work facilitates the use of these measures in Japanese clinical scenarios. We plan to further examine these measures in a psychometric evaluation study.

新型コロナウイルス感染症流行は、就労・学業・経済活動など社会に大きな影響を及ぼすとともに、多くの健康アウトカムや健康関連行動を悪化させている。我々はそうした社会や健康への影響を検討するために、JACSIS=Japan COVID-19 and Society Internet Survey（日本における社会と新型コロナウイルス感染症問題に関するインターネット調査研究）として、日本全国すべての都道府県から人口分布に合わせて2020年9月にサンプリングした28,000人を対象として調査を行い、その後も2021年2月、9月と縦断調査を行っている（https://takahiro-tabuchi.net/jacsis/）。2020年9月の調査から、新型コロナウイルス感染症流行下でメンタルヘルスが悪化する危険因子として、女性や若年とともに、低所得者と自営業、介護負担感の増加やドメスティックバイオレンス、そして新型コロナウイルス感染症そのものへの恐怖が重要な心理的不調の危険因子であることを示した。また居住環境に焦点を当てた解析から、メンタルヘルスの悪化が、新型コロナウイルス感染症患者発生の有無にかかわらず全国的な問題であり、特に人口密度が高い地域、貧困の度合いが高い地域であるほど、深刻であることを示した。心理的不調を来たす方の早期発見や支援、自殺予防は急務の課題であり、上記研究が少しでも参考になればと願っている。また、2021年2月の調査では、ワクチン忌避の実態を明らかにする研究を行った。ワクチンは感染収束の切り札として期待されている。ワクチン接種率を高め維持するための取り組みの一助になればと願っている。

<sec><title>Introduction</title>While major depression causes substantial distress and impairment for affected individuals and society, the effectiveness of cognitive behavioural therapy (CBT) in treating the condition has been established. However, the therapeutic mechanism underlying the efficacy of CBT remains unknown. This study aimed to describe a protocol for a randomised controlled trial that will measure the CBT-induced clinical and neural changes in patients with non-psychotic major depression. </sec><sec><title>Methods and analysis</title>The current study is a 16-week assessor-blinded, randomised, parallel-group trial with a 12-month follow-up as part of usual depression care at an outpatient clinic. Patients aged 20–69 years with major depressive disorder will be randomly assigned to receive either CBT in addition to their usual treatment or talking control in addition to their usual treatment for 16 weeks. The primary outcome is the functional changes in the brain areas that have been associated with future-oriented thinking at 16 weeks; secondary outcomes include changes in functional brain connectivity, severity and changes in the scores of objective and subjective clinical depression symptoms, proportion of responders and remitters and quality of life. The intention-to-treat analysis will be used. </sec><sec><title>Ethics and dissemination</title>All protocols and the informed consent form are compliant with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethical Review Committees at the Keio University School of Medicine have approved the study protocol (version 3, 11 September 2017). We will disseminate research findings to scientific and general audiences through national and international conference presentations as well as lay summaries to the general public, including mental health consumer and publications in international peer-reviewed psychiatry and brain imaging journals. </sec><sec><title>Trial registration number</title>UMIN Clinical Trials Registry (UMIN000018155); Pre-results. </sec>

BACKGROUND: Irritable bowel syndrome (IBS) is a common disease that affects the quality of life (QOL) and social functioning of sufferers. Visceral anxiety is currently considered a key factor in the onset and exacerbation of IBS, and cognitive-behavioural therapy (CBT) targeting visceral anxiety is thought to be effective. However, access to CBT is limited due to the lack of trained therapists, the substantial time required for therapy and the associated costs. Group CBT (GCBT) may solve some of these problems. We have therefore planned this trial to examine the efficacy of GCBT for IBS. METHODS: The trial is a two-armed, parallel group, open label, stratified block randomized superiority trial. The study group will consist of 112 participants (aged 18-75 years) with IBS (Rome-III or IV criteria). Participants will be randomly allocated 1:1 to (i) the intervention group: ten-week GCBT plus treatment as usual (TAU) or (ii) the control group: waiting list (WL) plus TAU. The co-primary outcomes are the change in IBS severity or disease-specific quality of life from baseline to week 13 which is 1 month after the end of treatment. The efficacy of GCBT for IBS will be examined through mixed-effects repeated-measures analysis. DISCUSSION: GCBT, if found effective, can address the issues of the shortage of therapists as well as the time required and the costs associated with individual CBT. Clinically, the findings will help make effective CBT programmes accessible to a large number of distressed IBS patients at lower costs. Theoretically, the results will clarify the relationship between IBS and psychological stress and will help elucidate the underlying mechanisms of IBS. TRIAL REGISTRATION: UMIN, CTR-UMIN000031710. Registered on March 13, 2018.