Hikari Nishimura Takashina

Background: Fatigue remains a major unresolved issue affecting the quality of life of patients with inflammatory bowel disease (IBD), even during clinical remission. Scalable psychological approaches are needed to support effective fatigue management. Objective: The aim of this study is to evaluate the effectiveness of a multicomponent mobile cognitive behavioral intervention package for fatigue management among patients with IBD in remission and to explore factors associated with engagement with the intervention and its effectiveness. Methods: This was an open-label, waitlist-controlled randomized controlled trial. Eligible participants were adults (≥18 years) diagnosed with Crohn disease or ulcerative colitis who met remission criteria and had at least mild fatigue. Participants were randomized 1:1 using stratified block randomization based on disease type, sex, and baseline fatigue severity. The intervention was a multicomponent mobile intervention package centered on a 7-week cognitive behavioral therapy–based educational course, supplemented by adjunctive support messages. The primary outcome was fatigue, measured using the Functional Assessment of Chronic Illness Therapy—Fatigue (FACIT-F), and the secondary outcome was self-efficacy, measured using the 13-item Inflammatory Bowel Disease Self-Efficacy Scale Short Form (IBD-SES13). A sample size of 175 participants per group was required. Results: Recruitment of participants began on July 28, 2025, and ended on February 24, 2026. A total of 502 patients with IBD in clinical remission agreed to participate and were assessed for eligibility. Among them, 351 met the eligibility criteria and were randomized, while 151 (30.0%) had FACIT-F scores of 40 or higher and were excluded. Currently, follow-up is ongoing. The clinical outcome data will be analyzed after follow-up is completed, and the results are expected to be submitted for publication in 2027. Conclusions: This study may contribute valuable knowledge regarding participant engagement and the potential impact of a multicomponent mobile cognitive behavioral intervention package on fatigue in patients with IBD. The findings will support future refinement of the intervention and inform large-scale evaluations and implementation efforts.

Objective: To assess the comparative efficacy and acceptability of cognitive behavioural therapy for insomnia (CBT-I), its abbreviated versions and control conditions. Design: Systematic review and network meta-analysis. Methods: Screening, data extraction, coding, and risk of bias assessment were performed independently and in duplicate. Frequentist, random-effects network meta-analyses estimated odds ratios (ORs) or mean differences with 95% confidence intervals (CIs). The primary outcome was insomnia remission post-treatment. Secondary outcomes included dropout and subjective sleep continuity measures. Quality of the evidence for each arm was graded using the confidence in network meta-analysis (CINeMA). Data sources: We searched MEDLINE, Embase, PsycINFO and Cochrane CENTRAL from inception to December 15, 2025, with a medical information specialist. Eligibility criteria for selecting studies: Randomized –controlled trials (RCTs) comparing CBT-I and its abbreviated versions with each other or with control conditions, in adults with insomnia, with or without comorbidities. To reduce clinical heterogeneity related to treatment intensity and adherence, we restricted inclusion to in-person delivery. Results: We identified 11,379 records and included 77 RCTs (5,731 participants; mean age 52.2 years; 3,473 female). CBT-I (number of arms k = 53; number of participants n = 2,002), sleep restriction and stimulus control therapy (SRT&SCT; k = 16; n = 549), sleep restriction therapy (SRT; k = 5; n = 196) and stimulus control therapy (SCT; k = 7; n = 144) were associated with higher remission than sleep hygiene, relaxation therapy and other control conditions. These interventions were also effective in improving subjective sleep continuity measures. Cognitive therapy for insomnia (CT-I) was more beneficial than relaxation therapy. Dropout did not differ meaningfully between interventions and controls. Confidence in evidence was moderate for CBT-I, low for SRT&SCT and SRT, very low for SCT. Given the weighted mean proportion of insomnia remission among sleep hygiene arms of 20%, CBT-I probably leads to a remission rate of 41% (95% CI, 34%; 48%), SRT&SCT may lead to a remission rate of 40% (30%; 52%), SCT 43% (25%; 63%), and SRT 41% (26%; 57%). Conclusions: CBT-I doubles the absolute insomnia remission compared with sleep hygiene, and its abbreviated behavioural therapies, namely, SRT&SCT, SCT and SRT may offer similar benefits with lower resource requirements, but evidence is less certain. CT-I needs further investigations. Relaxation therapy was inferior to these therapies. Implementation decisions should consider resource requirements and evidence certainty. What is already known on this topic: - Insomnia is prevalent and disabling, and cognitive behavioural therapy for insomnia (CBT-I) is recommended as the first-line treatment. - CBT-I and its abbreviated versions are recommended in guidelines, but their comparative efficacy and acceptability remain uncertain. What this study adds: - CBT-I and its core behavioural components (sleep restriction and stimulus control) probably achieve similar remission rates, offering scalable options where full CBT-I is not available. - Relaxation therapy was inferior to cognitive behavioural therapy for insomnia, its abbreviated, behavioural interventions, and cognitive therapy for insomnia. - Dissemination and implementation attempts should balance the confidence in the evidence and simplicity of abbreviated versions.

Background: With an increase in both the number of mental health disorders people are experiencing and the difficulty in accessing mental health care, the demand for accessible mental health care services has increased. The use of mobile devices has allowed people to receive care in their daily lives without restrictions on time or location. However, the majority of publicly available mobile health apps are not evidence-based, and the top-rated apps are not always safe or user-friendly and may not offer clinically beneficial results. Objective: This study aims to create a cultural adaptation of the American Psychiatric Association’s comprehensive app evaluation framework in Japan using a web-based modified Delphi expert consensus. Methods: A web-based modified Delphi study includes developing the Japanese version of the comprehensive app evaluation framework and 3 Delphi rounds. In the first round, our working group sends a questionnaire to the panelists, who then complete it. In the second and third rounds, the working group sends a questionnaire and a summary of the panelists’ answers based on each of the previous rounds. The panelists answer the questionnaires based on this summary. The summarization procedure is automated to help reduce the biases that can be generated when panelists’ answers are summarized and when the panelists receive them. The working group sends only the result of the summarization with the next round’s questionnaire. All interactions between the working group and the panelists will be conducted on Qualtrics (Qualtrics Japan LLC), a questionnaire platform. To culturally validate the comprehensive mental health app evaluation framework, participants from the following three categories will be recruited in Japan: (1) researchers, (2) practitioners, and (3) app developers. Results: This study received funding from a crowdfunding campaign in Japan (April 2023). The Delphi study began in January 2023 and will be completed in December 2023. We had already completed the translation of the 105 original app evaluation item questions by December 2022. Conclusions: While the need for treatment using mental health apps is increasing, no framework that can be used to develop a centralized database for health apps is available or accessible, and no consensus has been reached among stakeholders in Japan about an appropriate framework. The results of the web-based modified Delphi method presented in this paper may provide direction for the development and use of mental health apps in the future among the relevant stakeholders. Furthermore, this study will enhance recognition of the framework among researchers, clinicians, mental health app developers, and users, in addition to devising new instruments to help users or practitioners efficiently choose the right app for their situations. International Registered Report Identifier (IRRID): PRR1-10.2196/44469

Introduction The primary objective of the Multi-, Inter-, and Cross-cultural Clinical Child Study (MIXCS) is to evaluate the hypothesis that the effects of cultural-adapted cognitive behavioural therapy (CA-CBT) and programme-adopted cognitive behavioural therapy (PA-CBT) for children and adolescents’ anxiety are both superior to a psychological control (moral education control: MEC) for reducing child and adolescent anxiety disorders and symptoms as well as related constructs. The secondary objective is to explore commonalities and differences in therapy factors between CA-CBT and PA-CBT. Method and analysis The study has been designed as a randomised, controlled and assessor masked multicentre superiority trial with three groups: CA-CBT, PA-CBT and MEC. Primary outcome is remission of primary anxiety disorders evaluated by independent evaluators. Secondary outcomes are clinician’s severity ratings, child self-reported anxiety symptoms, depressive symptoms, cognitive errors and family accommodation, as well as parent-reported anxiety symptoms, and family accommodation. Competence and adherence of treatment, therapy factors in treatment sessions are also measured based on behavioural observation. Finally, satisfaction and comprehension are collected. We aim to recruit at least 99 families for the analysis. Treatment will be delivered weekly for 10 sessions and assessment will be conducted 2 weeks before the treatment (pre), 3 months after the base date when the treatment starts (post), 6 months (six months follow-up) and 12 months (12 months follow-up) after the postassessment. Ethics and dissemination The MIXCS study was approved by Doshisha University Research Ethics Review Committee, Kwansei Gakuin University Institutional Review Board for Medical and Biological Research Involving Human Subjects and Shinshu University Certified Review Board of Clinical Research. Regardless of the results, the primary outcome will be published in a journal, and if the efficacy and effectiveness of CA-CBT and/or PA-CBT are empirically supported, the authors will encourage dissemination of the programmes including the assessment system through key stakeholders in education, health, and welfare areas. Trial registration number UMIN000038128

Background: Chronic insomnia disorder is highly prevalent, disabling and costly. Cognitive-behavioural therapy for insomnia (CBT-I) is recommended as the first-line treatment. CBT-I may contain various educational, cognitive and behavioural strategies delivered in a range of formats, but the effect of each component remains unclear. Methods: We performed a systematic review and component network meta-analysis (cNMA) of CBT-I trials for chronic insomnia. We searched PubMed, CENTRAL, PsycINFO and ICTRP for randomised controlled trials published from database inception to 14 ^th May 2022, comparing any form of CBT-I against each other or a control condition for chronic insomnia disorder in adults (aged ≥18 years). We included insomnia both with and without comorbidities. Concomitant treatments were allowed if they were equally distributed among the arms. Two independent reviewers identified components, extracted data, and assessed trial quality. Primary outcome of interest in this study was treatment efficacy (remission defined as reaching a satisfactory state at endpoint measured by any validated self-reported scale) at post-treatment. (PROSPERO; CRD42022324233) Findings: We identified 226 trials, including 29,982 participants. Mean age was 45·7 years and 71% were women. The results suggests that critical components of CBT-I are cognitive restructuring (incremental odds ratio[iOR] 1·63 [95% confidence interval 1·25 to 2·14]), sleep restriction (iOR 1·44 [1·00 to 2·06]) and stimulus control (iOR 1·44 [1·00 to 2·07]) Sleep hygiene education was not essential (iOR 1·05 [0·79 to 1·38]) and relaxation procedures may be counterproductive (iOR 0·81 [0·64 to 1·03]). Face-to-face, therapist-led program was found to be most beneficial (iOR 1·86 [1·21to 2·85]). The overall risk of bias was low in 8% of the trials, some concerns in 56%, and high in 36%. Interpretation: This cNMA suggests that effective and efficient CBT-I packages can include cognitive restructuring, sleep restriction and stimulus control, but not relaxation. Funding: None.

BACKGROUND With an increase in both the number of mental health disorders people are experiencing and the difficulty in accessing mental health care, the demand for accessible mental health care services has increased. The use of mobile devices has allowed people to receive care in their daily lives without restrictions on time or location. However, the majority of publicly available mobile health apps are not evidence-based, and the top-rated apps are not always safe or user-friendly and may not offer clinically beneficial results. OBJECTIVE This study aims to create a cultural adaptation of the American Psychiatric Association’s comprehensive app evaluation framework in Japan using a web-based modified Delphi expert consensus. METHODS A web-based modified Delphi study includes developing the Japanese version of the comprehensive app evaluation framework and 3 Delphi rounds. In the first round, our working group sends a questionnaire to the panelists, who then complete it. In the second and third rounds, the working group sends a questionnaire and a summary of the panelists’ answers based on each of the previous rounds. The panelists answer the questionnaires based on this summary. The summarization procedure is automated to help reduce the biases that can be generated when panelists’ answers are summarized and when the panelists receive them. The working group sends only the result of the summarization with the next round’s questionnaire. All interactions between the working group and the panelists will be conducted on Qualtrics (Qualtrics Japan LLC), a questionnaire platform. To culturally validate the comprehensive mental health app evaluation framework, participants from the following three categories will be recruited in Japan: (1) researchers, (2) practitioners, and (3) app developers. RESULTS This study received funding from a crowdfunding campaign in Japan (April 2023). The Delphi study began in January 2023 and will be completed in December 2023. We had already completed the translation of the 105 original app evaluation item questions by December 2022. CONCLUSIONS While the need for treatment using mental health apps is increasing, no framework that can be used to develop a centralized database for health apps is available or accessible, and no consensus has been reached among stakeholders in Japan about an appropriate framework. The results of the web-based modified Delphi method presented in this paper may provide direction for the development and use of mental health apps in the future among the relevant stakeholders. Furthermore, this study will enhance recognition of the framework among researchers, clinicians, mental health app developers, and users, in addition to devising new instruments to help users or practitioners efficiently choose the right app for their situations. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/44469