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Background: We aimed to evaluate the comparative efficacy and acceptability of cognitive behavioral therapy for insomnia (CBT-I), pharmacotherapy, and their combination in the long and short terms among adults with chronic insomnia disorder., Methods: We searched multiple databases to December 27, 2023. We included trials in hypnotic-free adults with chronic insomnia comparing at least two of CBT-I, pharmacotherapy, or their combination. We assessed the confidence in evidence using CINeMA. The primary outcome was long-term remission. Secondary outcomes included all-cause dropout and self-reported sleep continuity measures in the long term, and the same outcomes in the short term. We performed frequentist random-effects network meta-analyses (CRD42024505519)., Findings: We identified 13 trials including 823 randomized participants (mean age, 47.8 years; 60% women). CBT-I was more beneficial than pharmacotherapy in the long term (median duration, 24 weeks [range, 12 to 48 weeks]; remission odds ratio, 1.82 [95% confidence interval (CI), 1.15-2.87]; [certainty of evidence: high]), while there was weaker evidence of benefit of combination against pharmacotherapy (1.71 [95% CI, 0.88-3.30: moderate]) and no clear difference of CBT-I against combination (1.07 [95% CI, 0.63-1.80: moderate]). CBT-I was associated with fewer dropouts than pharmacotherapy. Short-term outcomes favored CBT-I over pharmacotherapy except total sleep time. Given the average long-term remission rate in the pharmacotherapy-initiating arms of 28%, CBT-I resulted in a long-term remission rate of 41% (95% CI, 31%-53%) and combination 40% (95% CI, 25%-56%)., Interpretation: The current study found that starting with CBT-I for chronic insomnia leads to better outcomes than pharmacotherapy. Combination may be better than pharmacotherapy alone, but unlikely to be worth the additional burden over CBT-I alone., (© 2024 The Author(s). Psychiatry and Clinical Neurosciences published by John Wiley & Sons Australia, Ltd on behalf of Japanese Society of Psychiatry and Neurology.)

Background: Previous systematic reviews suggest that nurse-led interventions improve short-term blood pressure (BP) control for people with hypertension. However, the long-term effects, adverse events, and appropriate target BP level are unclear. This study aimed to evaluate the long-term efficacy and safety of nurse-led interventions., Methods: We conducted a systematic review and meta-analysis. We searched the Cochrane Central Register of Controlled Trials, PubMed, and CINAHL, as well as three Japanese article databases, as relevant randomized controlled trials from the oldest possible to March 2021. This search was conducted on 17 April 2021. We did an update search on 17 October 2023. We included studies on adults aged 18 years or older with hypertension. The treatments of interest were community-based nurse-led BP control interventions in addition to primary physician-provided care as usual. The comparator was usual care only. Primary outcomes were long-term achievement of BP control goals and serious adverse events (range: 27 weeks to 3 years). Secondary outcomes were short-term achievement of BP control goals and serious adverse events (range: 4 to 26 weeks), change of systolic and diastolic BP from baseline, medication adherence, incidence of hypertensive complications, and total mortality., Results: We included 35 studies. Nurse-led interventions improved long-term BP control (RR 1.10, 95%CI 1.03 to 1.18). However, no significant differences were found in the short-term effects of nurse-led intervention compared to usual care about BP targets. Little information on serious adverse events was available. There was no difference in mortality at both terms between the two groups. Establishing the appropriate target BP from the extant trials was impossible., Conclusions: Nurse-led interventions may be more effective than usual care for achieving BP control at long-term follow-up. It is important to continue lifestyle modification for people with hypertension. We must pay attention to adverse events, and more studies examining appropriate BP targets are needed. Nurse-led care represents an important complement to primary physician-led usual care., (© 2024. The Author(s).)

Objectives: This study aimed to investigate the utility of the RAND/UCLA appropriateness method (RAM) in validating expert consensus-based multiple-choice questions (MCQs) on electrocardiogram (ECG)., Methods: According to the RAM user's manual, nine panelists comprising various experts who routinely handle ECGs were asked to reach a consensus in three phases: a preparatory phase (round 0), an online test phase (round 1), and a face-to-face expert panel meeting (round 2). In round 0, the objectives and future timeline of the study were elucidated to the nine expert panelists with a summary of relevant literature. In round 1, 100 ECG questions prepared by two skilled cardiologists were answered, and the success rate was calculated by dividing the number of correct answers by 9. Furthermore, the questions were stratified into "Appropriate," "Discussion," or "Inappropriate" according to the median score and interquartile range (IQR) of appropriateness rating by nine panelists. In round 2, the validity of the 100 ECG questions was discussed in an expert panel meeting according to the results of round 1 and finally reassessed as "Appropriate," "Candidate," "Revision," and "Defer.", Results: In round 1 results, the average success rate of the nine experts was 0.89. Using the median score and IQR, 54 questions were classified as " Discussion." In the expert panel meeting in round 2, 23% of the original 100 questions was ultimately deemed inappropriate, although they had been prepared by two skilled cardiologists. Most of the 46 questions categorized as "Appropriate" using the median score and IQR in round 1 were considered "Appropriate" even after round 2 (44/46, 95.7%)., Conclusions: The use of the median score and IQR allowed for a more objective determination of question validity. The RAM may help select appropriate questions, contributing to the preparation of higher-quality tests., (© 2024. The Author(s).)

Importance: Chronic insomnia disorder is highly prevalent, disabling, and costly. Cognitive behavioral therapy for insomnia (CBT-I), comprising various educational, cognitive, and behavioral strategies delivered in various formats, is the recommended first-line treatment, but the effect of each component and delivery method remains unclear., Objective: To examine the association of each component and delivery format of CBT-I with outcomes., Data Sources: PubMed, Cochrane Central Register of Controlled Trials, PsycInfo, and International Clinical Trials Registry Platform from database inception to July 21, 2023., Study Selection: Published randomized clinical trials comparing any form of CBT-I against another or a control condition for chronic insomnia disorder in adults aged 18 years and older. Insomnia both with and without comorbidities was included. Concomitant treatments were allowed if equally distributed among arms., Data Extraction and Synthesis: Two independent reviewers identified components, extracted data, and assessed trial quality. Random-effects component network meta-analyses were performed., Main Outcomes and Measures: The primary outcome was treatment efficacy (remission defined as reaching a satisfactory state) posttreatment. Secondary outcomes included all-cause dropout, self-reported sleep continuity, and long-term remission., Results: A total of 241 trials were identified including 31 452 participants (mean [SD] age, 45.4 [16.6] years; 21 048 of 31 452 [67%] women). Results suggested that critical components of CBT-I are cognitive restructuring (remission incremental odds ratio [iOR], 1.68; 95% CI, 1.28-2.20) third-wave components (iOR, 1.49; 95% CI, 1.10-2.03), sleep restriction (iOR, 1.49; 95% CI, 1.04-2.13), and stimulus control (iOR, 1.43; 95% CI, 1.00-2.05). Sleep hygiene education was not essential (iOR, 1.01; 95% CI, 0.77-1.32), and relaxation procedures were found to be potentially counterproductive(iOR, 0.81; 95% CI, 0.64-1.02). In-person therapist-led programs were most beneficial (iOR, 1.83; 95% CI, 1.19-2.81). Cognitive restructuring, third-wave components, and in-person delivery were mainly associated with improved subjective sleep quality. Sleep restriction was associated with improved subjective sleep quality, sleep efficiency, and wake after sleep onset, and stimulus control with improved subjective sleep quality, sleep efficiency, and sleep latency. The most efficacious combination-consisting of cognitive restructuring, third wave, sleep restriction, and stimulus control in the in-person format-compared with in-person psychoeducation, was associated with an increase in the remission rate by a risk difference of 0.33 (95% CI, 0.23-0.43) and a number needed to treat of 3.0 (95% CI, 2.3-4.3), given the median observed control event rate of 0.14., Conclusions and Relevance: The findings suggest that beneficial CBT-I packages may include cognitive restructuring, third-wave components, sleep restriction, stimulus control, and in-person delivery but not relaxation. However, potential undetected interactions could undermine the conclusions. Further large-scale, well-designed trials are warranted to confirm the contribution of different treatment components in CBT-I.

Subthreshold depression impairs young people's quality of life and places them at greater risk of developing major depression. Cognitive behavioral therapy (CBT) is an evidence-based approach for addressing such depressive states. This study identified subtypes of university students with subthreshold depression and revealed discrete profiles of five CBT skills: self-monitoring, cognitive restructuring, behavioral activation, assertive communication, and problem solving. Using data from the Healthy Campus Trial (registration number: UMINCTR-000031307), a hierarchical clustering analysis categorized 1,080 students into three clusters: Reflective Low-skilled, Non-reflective High-skilled, and Non-reflective Low-skilled students. Non-reflective Low-skilled students were significantly more depressed than other students ( p  < .001). The severity of depression seemed to be related to the combination of self-monitoring skills and other CBT skills. Considering the high prevalence of poor self-monitoring skills in persons with autism, the most severe depression was observed in the significant association between Non-reflective Low-skilled students and autistic traits ( p  = .008). These findings suggest that subthreshold depression can be categorized into three subtypes based on CBT skill profiles. The assessment of autistic traits is also suggested when we provide CBT interventions for Non-reflective Low-skilled students.

Background: Internet-based cognitive-behavioural therapy (iCBT) is effective for subthreshold depression. However, iCBT has problems with adherence, especially when unaccompanied by human guidance. Knowledge on how to enhance adherence to iCBT without human involvement can contribute to improving the effectiveness of iCBT., Objective: This is an implementation study to examine the effect of an automated chatbot to improve the adherence rate of iCBT., Methods: We developed a chatbot to increase adherence to an existing iCBT programme, and a randomised controlled trial was conducted with two groups: one group using iCBT plus chatbot (iCBT+chatbot group) and one group not using the chatbot (iCBT group). Participants were full-time employees with subthreshold depression working in Japan (n=149, age mean=41.4 (SD=11.1)). The primary endpoint was the completion rate of the iCBT programme at 8 weeks., Findings: We analysed data from 142 participants for the primary outcome. The completion rate of the iCBT+chatbot group was 34.8% (24/69, 95% CI 23.5 to 46.0), that of the iCBT group was 19.2% (14/73, 95% CI 10.2 to 28.2), and the risk ratio was 1.81 (95% CI 1.02 to 3.21)., Conclusions: Combining iCBT with a chatbot increased participants' iCBT completion rate., Clinical Implications: Encouraging messages from the chatbot could improve participation in an iCBT programme. Further studies are needed to investigate whether chatbots can improve adherence to the programme in the long term and to assess their impact on depression, anxiety and well-being., Trial Registration Number: UMIN000047621., Competing Interests: Competing interests: TK, SY, TT, KY and RK are employees of Sony Corporation. TAF, HN and MS acted as advisors during the study. TAF reports personal fees from Boehringer Ingelheim, DT Axis, Kyoto University Original, MSD, Shionogi and Sony, and a grant from Shionogi, beyond the submitted work. In addition, TAF has patents 2020-548587 and 2022-082495 pending, and intellectual properties for Kokoro-app licensed to Mitsubishi-Tanabe. HN reports personal fees from Boehringer Ingelheim, Kyowa Kirin, Toyota Motor Corporation, GlaxoSmithKline, Ono Pharmaceutical, Sony and Terumo beyond the submitted work. MS reports personal fees from Sony beyond the submitted work. All other authors declare no conflict of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. Published by BMJ.)

Introduction: Although the ECG is an important diagnostic tool in medical practice, the competency of ECG interpretation is considered to be poor. Diagnostic inaccuracy involving the misinterpretation of ECG can lead to inappropriate medical judgements and cause negative clinical outcomes, unnecessary medical testing and even fatalities. Despite the importance of assessing ECG interpretation skills, there is currently no established universal, standardised assessment tool for ECG interpretation. The current study seeks to (1) develop a set of items (ECG questions) for estimating competency of ECG interpretation by medical personnel by consensus among expert panels following a process based on the RAND/UCLA Appropriateness Method (RAM) and (2) analyse item parameters and multidimensional latent factors of the test set to develop an assessment tool., Methods and Analysis: This study will be conducted in two steps: (1) selection of question items for ECG interpretation assessment by expert panels via a consensus process following RAM and (2) cross-sectional, web-based testing using a set of ECG questions. A multidisciplinary panel of experts will evaluate the answers and appropriateness and select 50 questions as the next step. Based on data collected from a predicted sample size of 438 test participants recruited from physicians, nurses, medical and nursing students, and other healthcare professionals, we plan to statistically analyse item parameters and participant performance using multidimensional item response theory. Additionally, we will attempt to detect possible latent factors in the competency of ECG interpretation. A test set of question items for ECG interpretation will be proposed on the basis of the extracted parameters., Ethics and Dissemination: The protocol of this study was approved by the Institutional Review Board of Ehime University Graduate School of Medicine (IRB number: 2209008). We will obtain informed consent from all participants. The findings will be submitted for publication in peer-reviewed journals., Competing Interests: Competing interests: TAF reports personal fees from Boehringer-Ingelheim, DT Axis, Kyoto University Original, Shionogi and SONY, and a grant from Shionogi, outside the submitted work. In addition, TAF has patents 2020-548587 and 2022-082495 pending, and intellectual property for Kokoro-app licensed to Mitsubishi-Tanabe. KY and MW have patent 2022-193813 pending outside the submitted work. MS reports personal fees from SONY outside the submitted work. The Institute for Airway Disease received a system development fee from the Department of Cardiology, Pulmonology, Nephrology and Hypertension, Ehime University Graduate School of Medicine. All other authors have no conflict of interest., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The health burden due to depression is ever increasing in the world. Prevention is a key to reducing this burden. Guided internet cognitive-behavioural therapies (iCBT) appear promising but there is room for improvement because we do not yet know which of various iCBT skills are more efficacious than others, and for whom. In addition, there has been no platform for iCBT that can accommodate ongoing evolution of internet technologies., Methods and Analysis: Based on our decade-long experiences in developing smartphone CBT apps and examining them in randomised controlled trials, we have developed the Resilience Training App Version 2. This app now covers five CBT skills: cognitive restructuring, behavioural activation, problem-solving, assertion training and behaviour therapy for insomnia. The current study is designed as a master protocol including four 2×2 factorial trials using this app (1) to elucidate specific efficacies of each CBT skill, (2) to identify participants' characteristics that enable matching between skills and individuals, and (3) to allow future inclusion of new skills. We will recruit 3520 participants with subthreshold depression and ca 1700 participants without subthreshold depression, to examine the short-term efficacies of CBT skills to reduce depressive symptoms in the former and to explore the long-term efficacies in preventing depression in the total sample. The primary outcome for the short-term efficacies is the change in depressive symptoms as measured with the Patient Health Questionnaire-9 at week 6, and that for the long-term efficacies is the incidence of major depressive episodes as assessed by the computerised Composite International Diagnostic Interview by week 50., Ethics and Dissemination: The trial has been approved by the Ethics Committee of Kyoto University Graduate School of Medicine (C1556)., Trial Registration Number: UMIN000047124., Competing Interests: Competing interests: TAF, MH and TA jointly possess intellectual properties of the Resilience Training App. TAF reports personal fees from Boehringer-Ingelheim, DT Axis, Kyoto University Original, Shionogi and SONY, and a grant from Shionogi, outside the submitted work; In addition, TAF has patents 2020-548587 and 2022-082495 pending, and intellectual properties for Kokoro-app licensed to Mitsubishi-Tanabe. AT received lecture fees from Sumitomo Dainippon Pharma, Eisai, Janssen Pharmaceutical, Meiji-Seika Pharma, Mitsubishi Tanabe Pharma, Otsuka, and Takeda Pharmaceutical. MS reports personal fee from SONY outside the submitted work. TA has received lecture fees from Chugai, Daiichi-Sankyo, Dainippon-Sumitomo, Eizai, Janssen, Kyowa, Lilly, MSD, Meiji-Seika Pharma, Mochida, Nipro, Nihon-Zoki, Otsuka, Pfizer, Takeda and Viatris; and royalties from Igaku-shoin, outside the submitted work. TA has patents (2019-01749 and 2020-135195&2022-069057) pending. NKa reports personal fees from Junpukai Foundation, Riken Institute, JAXA, Sekisui Chemical Co and SB@Work, outside the submitted work; and Department of Digital Mental Health is an endowment department, supported with an unrestricted grant from 15 enterprises (https://dmh.m.u-tokyo.ac.jp/c). TN reports personal fees from Pfizer, MSD, Ohtsuka, Chuga, Dentsu, Takeda, Janssen, Boehringer Ingelheim, Eli Lilly, Mitsubishi Tanabe, Novartis, Allergan, Maruho, Novo Nordisk, TOA EIYO; and research grants from I&H Co, Cocokarafine Group Co and Konica Minolta, all outside the submitted work. HN received a research fund from GlaxoSmithKline and consulting fees from Kyowa Kirin, GlaxoSmithKline, Ono Pharmaceutical, Sony, Terumo, outside the submitted work. JMSW reports research funding from Boehringer-Ingelheim, GSK, Intercept, UCB, all outside the current work. All the other coauthors declare no conflicts of interests., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Internet-cognitive behavioural therapy (iCBT) for depression can include multiple components. This study explored depressive symptom improvement prognostic factors (PFs) and effect modifiers (EMs) for five common iCBT components including behavioural activation, cognitive restructuring, problem solving, self-monitoring, and assertion training., Methods: We used data from a factorial trial of iCBT for subthreshold depression among Japanese university students (N = 1093). The primary outcome was the change in PHQ-9 scores at 8 weeks from baseline. Interactions between each component and various baseline characteristics were estimated using a mixed-effects model for repeated measures. We calculated multiplicity-adjusted p-values at 5 % false discovery rate using the Benjamini-Hochberg procedure., Results: After multiplicity adjustment, the baseline PHQ-9 total score emerged as a PF and exercise habits as an EM for self-monitoring (adjusted p-values <0.05). The higher the PHQ-9 total score at baseline (range: 5-14), the greater the decrease after 8 weeks. For each 5-point increase at baseline, the change from baseline to 8 weeks was bigger by 2.8 points. The more frequent the exercise habits (range: 0-2 points), the less effective the self-monitoring component. The difference in PHQ-9 change scores between presence or absence of self-monitoring was smaller by 0.94 points when the participant exercised one level more frequently. Additionally, the study suggested seven out of 36 PFs and 14 out of 160 EMs examined were candidates for future research., Limitations: Generalizability is limited to university students with subthreshold depression., Conclusions: These results provide some helpful information for the future development of individualized iCBT algorithms for depression., Competing Interests: Conflict of interest TAF reports personal fees from Boehringer-Ingelheim, DT Axis, Kyoto University Original, MSD, Shionogi and SONY, and a grant from Shionogi, outside the submitted work; In addition, TAF has patents 2020-548587 and 2022-082495 pending, and intellectual properties for Kokoro-app licensed to Mitsubishi-Tanabe. MS reports personal fees from SONY outside the submitted work. NS received lecture fees from Meiji-seika Pharma for work that was not associated with this article. AT has received lecture fees from Sumitomo Dainippon Pharma, Eisai, Janssen Pharmaceutical, Meiji-Seika Pharma, Mitsubishi Tanabe Pharma, Otsuka, and Takeda Pharmaceutical. TM received lecture fees from Aikomi and LinkMedical for work outside the submitted work. HN reports personal fees from Boehringer Ingelheim, Kyowa Kirin, Toyota Motor Corporation, GlaxoSmithKline, Ono Pharmaceutical, SONY, and Terumo outside the submitted work. All the other authors have no competing interests to report., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Internet-based cognitive-behavioural therapy (iCBT) is effective for subthreshold depression. However, which skills provided in iCBT packages are more effective than others is unclear. Such knowledge can inform construction of more effective and efficient iCBT programmes., Objective: To examine the efficacy of five components of iCBT for subthreshold depression., Methods: We conducted an factorial trial using a smartphone app, randomly allocating presence or absence of five iCBT skills including self-monitoring, behavioural activation (BA), cognitive restructuring (CR), assertiveness training (AT) and problem-solving. Participants were university students with subthreshold depression. The primary outcome was the change on the Patient Health Questionnaire-9 (PHQ-9) from baseline to week 8. Secondary outcomes included changes in CBT skills., Findings: We randomised a total of 1093 participants. In all groups, participants had a significant PHQ-9 reduction from baseline to week 8. Depression reduction was not significantly different between presence or absence of any component, with corresponding standardised mean differences (negative values indicate specific efficacy in favour of the component) ranging between -0.04 (95% CI -0.16 to 0.08) for BA and 0.06 (95% CI -0.06 to 0.18) for AT. Specific CBT skill improvements were noted for CR and AT but not for the others., Conclusions: There was significant reduction in depression for all participants regardless of the presence and absence of the examined iCBT components., Clinical Implication: We cannot yet make evidence-based recommendations for specific iCBT components. We suggest that future iCBT optimisation research should scrutinise the amount and structure of components to examine., Trial Registration Number: UMINCTR-000031307., Competing Interests: Competing interests: MS reports personal fees from SONY outside the submitted work. TAF reports grants and personal fees from Mitsubishi-Tanabe, personal fees from SONY, and personal fees from Shionogi, outside the submitted work; In addition, TAF has a patent 2020-548587 concerning smartphone CBT apps pending, and intellectual properties for Kokoro-app licensed to Mitsubishi-Tanabe. AT has received lecture fees from Dainippon-Sumitomo, Eisai, Janssen, Meiji, Mitsubishi-Tanabe, Otsuka, and Takeda. Nao Shiraishi received lecture fees from Mochida Pharma outside the submitted work. Takashi Muto received lecture fees from Aikomi and LinkMedical for work outside the submitted work. TS is employed by the Kyoto University Health Service and Health Tech Laboratory Joint Research Fund. TU received personal fees from Dainippon-Sumitomo and Shionogi Pharma outside the submitted work. Hisashi Noma reports personal fees from Boehringer Ingelheim, Kyowa Kirin, Toyota Motor Corporation, GlaxoSmithKline, Ono Pharmaceutical, SONY, and Terumo outside the submitted work. All the other authors have no competing interests to report., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Background: Although the global market of Mobile Health Apps (mHealth apps) continues to grow dramatically, most mHealth apps still not only lack evidence base but have even not been evaluated for the basic usability or functionality. The User Version of the Mobile App Rating Scale (uMARS) was developed to allow end users to assess mHealth apps objectively and subjectively. However, there is no Japanese version of uMARS to date., Objective: The purpose of this study is (1) to develop a validated Japanese version of uMARS and (2) to assess the translated version's reliability and validity in evaluating mHealth apps., Methods: The original uMARS was adapted for Japanese use by four specialists using universalist cross-cultural methods. Translation/back-translation was reviewed by the author of the original version of uMARS, and confirmed. Its reliability and validity were further evaluated as part of a prospective cohort study of postoperative patients using a new mHealth app., Results: Conceptual equivalence was analyzed and all items in all subcategories of the original uMARS were included in the Japanese version. Internal consistency was deemed acceptable for all subscales of objective and subjective quality with a Cronbach's alpha of 0.75-0.85. Test-retest reliability of all subscales was also acceptable with intraclass correlation coefficients (ICCs) of 0.57-0.88. Convergent/divergent validity and concurrent validity were also considered acceptable., Conclusion: A Japanese version of uMARS was cross-culturally validated and found to be as reliable as the original uMARS. This Japanese version of uMARS is expected to become a standard tool in assessing the quality of mHealth apps in Japan., (Copyright © 2022 Elsevier B.V. All rights reserved.)

The Japanese Big Five Scale Short Form (JBFS-SF), a 29-item self-report scale, has recently been used to measure the Big Five personality traits. However, the scale lacks psychometric validation. This study examined the validity and reliability of the JBFS-SF with data collected from 1,626 Japanese university students participating in a randomized controlled clinical trial. Structural validity was tested with exploratory and confirmatory factor analysis and measurement invariance tests were conducted across sex. Internal consistency was evaluated with McDonald's omega. Additionally, construct validity was estimated across factors using the PHQ-9, GAD-7, AQ-J-10, and SSQ. EFA results showed that the JBFS-SF can be classified according to the expected five-factor structure, while three items had small loadings. Therefore, we dropped these three items and tested the reliability and validity of the 26-item version. CFA results found that a 26-item JBFS-FS has adequate structural validity (GFI = 0.907, AGFI = 0.886, CFI = 0.907, and RMSEA = 0.057). The omega of each factor was 0.74-0.85. Each JBFS-SF factor was specifically correlated with the PHQ-9, GAD-7, and SSQ. This research has shown that the JBFS-SF can be a clinically useful measure for assessing personality characteristics., Competing Interests: YS was employed by Goryokai Medical Corporation. TF reports grants and personal fees from Mitsubishi-Tanabe, personal fees from SONY, grants, and personal fees from Shionogi, COI outside the submitted work; in addition, TF has a patent 2020-548587 concerning smartphone CBT apps pending, and intellectual properties for Kokoro-app licensed to Mitsubishi-Tanabe. MSa reports personal fees from SONY outside the submitted work. AT has received lecture fees from Sumitomo Dainippon Pharma, Eisai, Janssen Pharmaceutical, Meiji-Seika Pharma, Mitsubishi Tanabe Pharma, Otsuka, and Takeda Pharmaceutical. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Toyomoto, Sakata, Yoshida, Luo, Nakagami, Iwami, Aoki, Irie, Sakano, Suga, Sumi, Ichikawa, Watanabe, Tajika, Uwatoko, Sahker and Furukawa.)

Background: Black clients in substance use disorder (SUD) treatment are associated with the lowest successful completion and substance use reductions. More work is needed to identify specific factors that support successful recovery of Black clients., Methods: Data from U.S. outpatient SUD treatment facilities receiving public funding from 2015 to 2019 were analyzed (N = 2239,197). Primary analyses consisted of Black clients (n = 277,726) reporting admission and discharge substance use frequency. Multiple logistic regression was used to predict substance use frequency improvement from Black client demographic, recovery capital, treatment characteristics, and state. Disparities were compared between Black and non-Black clients., Results: The overall Black client improvement percentage was 46.95%. Mutual-help group attendance and Length of Stay demonstrated clinically meaningful effect sizes controlling for all other variables and state. Attending mutual-help groups 8-30 times per month (State aOR = 2.54, 95% CI = 2.43, 2.64) and outpatient treatment stays of 4 months or more (State aOR = 2.50, 95% CI = 2.44, 2.56) were factors supporting Black client improvement. Importantly, states are associated with disparate Black client risk differences and only South Dakota had greater Black improvement (RD = 6.35, 95% CI = 1.00, 11.71)., Conclusions: Black client factors supporting substance use improvement include ancillary mutual-help group attendance and increased treatment retention. These factors may be more critical in states with larger Black improvement disparities. In general, treatment providers increasing access to mutual-help groups, and adjusting program inclusiveness and motivational factors for retention, would make strides in increasing improvement outcomes for Black clients., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: The number of mobile health (mHealth) apps continues to rise each year. Widespread use of the Mobile App Rating Scale (MARS) has allowed objective and multidimensional evaluation of the quality of these apps. However, no Japanese version of MARS has been made available to date., Objective: The purposes of this study were (1) to develop a Japanese version of MARS and (2) to assess the translated version's reliability and validity in evaluating mHealth apps., Methods: To develop the Japanese version of MARS, cross-cultural adaptation was used using a universalist approach. A total of 50 mental health apps were evaluated by 2 independent raters. Internal consistency and interrater reliability were then calculated. Convergent and divergent validity were assessed using multitrait scaling analysis and concurrent validity., Results: After cross-cultural adaptation, all 23 items from the original MARS were included in the Japanese version. Following translation, back-translation, and review by the author of the original MARS, a Japanese version of MARS was finalized. Internal consistency was acceptable by all subscales of objective and subjective quality (Cronbach α=.78-.89). Interrater reliability was deemed acceptable, with the intraclass correlation coefficient (ICC) ranging from 0.61 to 0.79 for all subscales, except for "functionality," which had an ICC of 0.40. Convergent/divergent validity and concurrent validity were also considered acceptable. The rate of missing responses was high in several items in the "information" subscale., Conclusions: A Japanese version of MARS was developed and shown to be reliable and valid to a degree that was comparable to the original MARS. This Japanese version of MARS can be used as a standard to evaluate the quality and credibility of mHealth apps., (©Kazumichi Yamamoto, Masami Ito, Masatsugu Sakata, Shiho Koizumi, Mizuho Hashisako, Masaaki Sato, Stoyan R Stoyanov, Toshi A Furukawa. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 14.04.2022.)

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., (Copyright © 2022 by The American College of Gastroenterology.)

Major depression is often a relapsing disorder. It is therefore important to start its treatment with therapies that maximize the chance of not only getting the patients well but also keeping them well. We examined the associations between initial treatments and sustained response by conducting a network meta-analysis of randomized controlled trials (RCTs) in which adult patients with major depression were randomized to acute treatment with a psychotherapy (PSY), a protocolized antidepressant pharmacotherapy (PHA), their combination (COM), standard treatment in primary or secondary care (STD), or pill placebo, and were then followed up through a maintenance phase. By design, acute phase treatment could be continued into the maintenance phase, switched to another treatment or followed by discretionary treatment. We included 81 RCTs, with 13,722 participants. Sustained response was defined as responding to the acute treatment and subsequently having no depressive relapse through the maintenance phase (mean duration: 42.2±16.2 weeks, range 24-104 weeks). We extracted the data reported at the time point closest to 12 months. COM resulted in more sustained response than PHA, both when these treatments were continued into the maintenance phase (OR=2.52, 95% CI: 1.66-3.85) and when they were followed by discretionary treatment (OR=1.80, 95% CI: 1.21-2.67). The same applied to COM in comparison with STD (OR=2.90, 95% CI: 1.68-5.01 when COM was continued into the maintenance phase; OR=1.97, 95% CI: 1.51-2.58 when COM was followed by discretionary treatment). PSY also kept the patients well more often than PHA, both when these treatments were continued into the maintenance phase (OR=1.53, 95% CI: 1.00-2.35) and when they were followed by discretionary treatment (OR=1.66, 95% CI: 1.13-2.44). The same applied to PSY compared with STD (OR=1.76, 95% CI: 0.97-3.21 when PSY was continued into the maintenance phase; OR=1.83, 95% CI: 1.20-2.78 when PSY was followed by discretionary treatment). Given the average sustained response rate of 29% on STD, the advantages of PSY or COM over PHA or STD translated into risk differences ranging from 12 to 16 percentage points. We conclude that PSY and COM have more enduring effects than PHA. Clinical guidelines on the initial treatment choice for depression may need to be updated accordingly., (© 2021 World Psychiatric Association.)

Background: There are many different skill components used in cognitive behavioural therapy (CBT). However, there is currently no comprehensive way of measuring these skills in patients., Objective: To develop a comprehensive and brief measure of five main CBT skills: self-monitoring, behavioural activation, cognitive restructuring, assertiveness training and problem-solving., Methods: University students (N=847) who participated in a fully factorial randomised controlled trial of smartphone CBT were assessed with the CBT Skills Scale, the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) and the short form of the Japanese Big Five Scale. Structural validity was estimated with exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), and internal consistency evaluated with Cronbach's α coefficients. Construct validity was evaluated with the correlations between each factor of the CBT Skills Scale, the PHQ-9, the GAD-7 and the Big Five Scale., Findings: The EFA supported a five-factor solution based on the original instruments assessing each CBT skill component. The CFA showed sufficient goodness-of-fit indices for the five-factor structure. The Cronbach's α of each factor was 0.75-0.81. Each CBT skills factor was specifically correlated to the PHQ-9, GAD-7, and the Big Five Scale., Conclusions: The CBT Skills Scale has a stable structural validity and internal consistency with a five-factor solution and appropriate content validity concerning the relationship with depression, anxiety and personality., Clinical Implications: The CBT Skills Scale will be potential predictor and effect modifier in studying the optimisation of CBT interventions., Trial Registration: CTR-000031307., Competing Interests: Competing interests: TAF reports personal fees from Mitsubishi-Tanabe, MSD and Shionogi, a grant from Mitsubishi-Tanabe, and, outside the submitted work; TAF has a patent 2018-177688 pending and intellectual properties for Kokoro-app licensed. NS received lecture fees from Dainippon-Sumitomo and Meiji-seika Pharma for work that was not associated with this article., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Drug misuse is associated with significant global morbidity, mortality, economic costs and social costs. Many primary care facilities have integrated drug misuse screening and brief intervention (BI) into their usual care delivery. However, the efficacy of BI for drug misuse in primary care has not been substantiated through meta-analysis. The aim of this systematic review and meta-analysis is to determine the efficacy of BI for drug misuse in primary care settings., Methods and Analysis: We will include all randomised controlled trials comparing primary care-delivered BI for drug misuse with no intervention or minimal screening/assessment and usual care. Primary outcomes are (1) drug use frequency scores and (2) severity scores at intermediate follow-up (4-8 months). We will retrieve all studies through searches in CENTRAL, Embase, MEDLINE and PsycINFO until 31 May 2020. The reference list will be supplemented with searches in trial registries (eg, www.clinicaltrials.gov) and through relevant existing study reference lists identified in the literature. We will conduct a random-effect pairwise meta-analysis for primary and secondary outcomes. We will assess statistical heterogeneity though visual inspection of a forest plot and calculate I 2 statistics. We will assess risk of bias using the Cochrane Risk of Bias Tool V.2 and evaluate the certainty of evidence through the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Sensitivity analyses will account for studies with control group variations and studies with a high risk of bias. If heterogeneity is present, subgroup analyses will consider patient variables of age, sex/gender, race/ethnicity, per cent insured, baseline severity and primary drug misused., Ethics and Dissemination: This study will use published aggregate data and will not require ethical approval. Findings will be disseminated in a peer-reviewed journal., Competing Interests: Competing interests: TAF reports personal fees from Mitsubishi-Tanabe, MSD and Shionogi, and a grant from Mitsubishi-Tanabe, outside the submitted work; TAF has a patent (2018-177688) pending. All the other authors report no competing interest., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Racial/ethnic disparities exist at many levels of substance use disorder (SUD) treatment and recovery, reflecting biological and socioeconomic factors. However, racial/ethnic disparities in SUD treatment effectiveness have not been sufficiently investigated., Methods: Data for US outpatient SUD treatment facilities receiving public funding from 2015 to 2017 were analyzed using the Treatment Episode Datasets-Discharge (TEDS-D). The study sample (N = 72,242) were White (n = 51,663), Black (n = 11,789), and Latino (n = 8782) clients reporting substance use frequency at admission and discharge. Multiple logistic regression was used to predict substance use improvement from race/ethnicity, socioeconomic variables, and their interactions. Moderating effects and their clinically meaningful effect sizes of risk differences (RD) were of primary interest., Results: The simple improvement comparison was statistically significant (χ 2 [2] = 380.59, p < 0.0001). Latino clients improved more (RD = 5.12, 95 % CI = 4.02, 6.22) and Black clients improved less than White clients (RD = -7.93, 95 % CI = -8.93, -6.93). However, race/ethnicity significantly and meaningfully moderated the relationship between substance use improvement and age, employment status, problem substance, and referral source (Wald χ 2 [77] = 5005.94, p < 0.0001)., Conclusions: Latinos demonstrated greater use improvement than Black and White clients. Socioeconomic characteristics moderated this general tendency. Culturally sensitive treatments can be enhanced by addressing culturally specific needs according to client age, employment, specific problem substance, and referral source. For example, Black clients referred from school improved more than Whites and Latinos. Increasing resources for school referrals may further improve Black client outcomes., Competing Interests: Declaration of Competing Interest TAF reports personal fees from Mitsubishi-Tanabe, MSD and Shionogi, and a grant from Mitsubishi-Tanabe, outside the submitted work; TAF has a patent 2018–177688 pending., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Aims: The Hamilton Depression Rating Scale (HAMD) and the Beck Depression Inventory (BDI) are the most frequently used observer-rated and self-report scales of depression, respectively. It is important to know what a given total score or a change score from baseline on one scale means in relation to the other scale., Methods: We obtained individual participant data from the randomised controlled trials of psychological and pharmacological treatments for major depressive disorders. We then identified corresponding scores of the HAMD and the BDI (369 patients from seven trials) or the BDI-II (683 patients from another seven trials) using the equipercentile linking method., Results: The HAMD total scores of 10, 20 and 30 corresponded approximately with the BDI scores of 10, 27 and 42 or with the BDI-II scores of 13, 32 and 50. The HAMD change scores of -20 and -10 with the BDI of -29 and -15 and with the BDI-II of -35 and -16., Conclusions: The results can help clinicians interpret the HAMD or BDI scores of their patients in a more versatile manner and also help clinicians and researchers evaluate such scores reported in the literature or the database, when scores on only one of these scales are provided. We present a conversion table for future research.

Background: Youth in general and college life in particular are characterized by new educational, vocational, and interpersonal challenges, opportunities, and substantial stress. It is estimated that 30-50% of university students meet criteria for some mental disorder, especially depression, in any given year. The university has traditionally provided many channels to promote students' mental health, but until now only a minority have sought such help, possibly owing to lack of time and/or to stigma related to mental illness. Smartphone-delivered cognitive behavioral therapy (CBT) shows promise for its accessibility and effectiveness. However, its most effective components and for whom it is more (or less) effective are not known., Methods/design: Based on the multiphase optimization strategy framework, this study is a parallel-group, multicenter, open, fully factorial trial examining five smartphone-delivered CBT components (self-monitoring, cognitive restructuring, behavioral activation, assertion training, and problem solving) among university students with elevated distress, defined as scoring 5 or more on the Patient Health Questionnaire-9 (PHQ-9). The primary outcome is change in PHQ-9 scores from baseline to week 8. We will estimate specific efficacy of the five components and their interactions through the mixed-effects repeated-measures analysis and propose the most effective and efficacious combinations of components. Effect modification by selected baseline characteristics will be examined in exploratory analyses., Discussion: The highly efficient experimental design will allow identification of the most effective components and the most efficient combinations thereof among the five components of smartphone CBT for university students. Pragmatically, the findings will help make the most efficacious CBT package accessible to a large number of distressed university students at reduced cost; theoretically, they will shed light on the underlying mechanisms of CBT and help further advance CBT for depression., Trial Registration: UMIN, CTR-000031307 . Registered on February 14, 2018.

In Japan, mergers of cities, towns, and villages have occurred rapidly as a result of the Special Law on the Merger of Municipalities, enacted in 2005. These mergers may impact civil servants' psychological adjustment. We developed the Municipal Merger Stress Questionnaire (MMSQ) to measure the impact of the municipal mergers and collected responses from 570 employees who had experienced a municipal merger (Study 1). We examined the relationships among the impact of municipal merger, Stress Responses, Self-concept (self-esteem and interpersonal dependency), and Social Support (Study 2). Two factors (Increased Workload and Worthlessness) were derived from the MMSQ in Study 1. Additionally, a structural equation model showed that the impact of the loss of value of their job (Worthlessness) related to the psychological stress responses, while job discretion did not differentiate an entire stress situation in Study 2. The result implies that psychological aspects of interventions focused on worthlessness are required to maintain good mental health of public servants at workplaces.

This longitudinal study was undertaken to clarify the relationships among self-esteem, interpersonal dependency, and depression, focusing on a trait and state component of interpersonal dependency and depression. In a sample of 466 working people, self-esteem, interpersonal dependency, job stressor, and depression were assessed at 2 points of time. A structural equation model (SEM) was created to differentiate the trait component of interpersonal dependency, depression and the state component of interpersonal dependency, depression. The model revealed that self-esteem influenced trait interpersonal dependency and trait depression but not state interpersonal dependency or depression. Setting a latent variable as a trait component to differentiate trait and state in interpersonal dependency and depression in SEM was found to be effective both statistically and clinically., (© 2011 Wiley Periodicals, Inc.)