Rie Toyomoto

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.

This study aimed to examine the effectiveness of smartphone-delivered cognitive behavioral therapy (CBT) in participants with subthreshold depression, considering the potential influence of physical comorbidities. In this secondary analysis of the RESiLIENT trial, participants with subthreshold depression were randomized to various CBT interventions or control groups. Physical comorbidities were self-reported at baseline and categorized as no, past, or current. Depression severity was assessed by the Patient Health Questionnaire-9 (PHQ-9) at weeks 6 and 26. Mixed-effects models for repeated measures estimated treatment effects and tested interaction terms for comorbidity category. Latent class analysis (LCA) explored multimorbidity patterns and their impact on outcomes. A total of 3577 participants were analyzed (no comorbidity n = 1384; past comorbidity n = 1004; current comorbidity n = 1189). All CBT interventions improved PHQ-9 scores at week 6 across comorbidity groups. Behavioral activation (BA) combined with problem solving showed the largest effects in the no comorbidity (least-squares mean difference = -1.74, 95% confidence interval: -2.44 to -1.05) and current comorbidity groups (-1.94, -2.67 to -1.20), while BA alone was most effective in the past comorbidity group (-1.91, -2.69 to -1.14). By week 26, BA combined with cognitive restructuring maintained benefits across all groups. LCA identified five multimorbidity classes. Although the effect sizes showed small variations across subgroups, no significant effect modification by comorbidity type was found. Smartphone-delivered CBT effectively reduces depressive symptoms in subthreshold depression, including among individuals with physical comorbidities. Although comorbidity type did not significantly modify outcomes, the observed patterns may help inform personalized iCBT strategies.

Background: Smartphone-based cognitive behavioral therapy (CBT) programs offer accessible interventions for subthreshold depression, yet engagement needed for meaningful benefit remains unclear. We examined how lesson and worksheet engagement relate to depressive symptom improvements in a behavioral activation (BA) intervention, accounting for time-varying confounders. Methods: This secondary analysis included 298 adults assigned to the BA arm of the RESiLIENT trial, a randomized controlled trial in Japan. Lesson and worksheet completion were treated as time-varying exposures, each yielding four engagement patterns: minimal (Few-Few) , early (Many-Few) , late (Few-Many) , and consistently high (Many-Many). Outcomes were depressive symptom changes measured by the Patient Health Questionnaire-9 (PHQ-9) at weeks 6 and 26. We applied the parametric g-formula to estimate counterfactual PHQ-9 changes under each pattern, adjusting for baseline and time-varying confounders. Results: Early lesson engagement during weeks 0–3 was associated with larger PHQ-9 reductions at both weeks 6 and 26, even when later engagement declined ( Many-Few vs. Few-Few : week 6: −1.47 [95% CI −2.52 to −0.53]; week 26: −1.27 [−2.53 to −0.17]). In contrast, higher worksheet engagement was linked to improved PHQ-9 at week 6, with maximal benefit among consistently high engagers ( Many-Many vs. Few-Few : −1.25 [−2.17 to −0.44]) and late engagers ( Few-Many vs. Few-Few : −1.18 [−2.20 to −0.08]), but not persist to week 26. Conclusions: Greater engagement with smartphone-delivered BA is associated with larger symptom reductions. Early lesson engagement drives sustained benefit, whereas worksheet engagement did not persist. These findings may guide digital CBT design by emphasizing early lesson completion alongside concurrent skill practice.

Introduction The global burden of depression continues to rise despite evidence that prevention is feasible and cost-effective. Building on the Resilience Enhancement with Smartphone in Living ENvironmenTs (RESiLIENT) randomised controlled trial, the Best, Efficient and Affordable Training in Resilience in Constant Evolution (BEATRICE) platform trial evaluates and optimises smartphone-delivered cognitive–behavioural therapy (CBT) for adults with no to subthreshold depression. The primary objective is to minimise the Total Burden of Depression, measured by the integral of weekly to monthly Patient Health Questionnaire-8 (PHQ-8) scores over 12 months, through a living, adaptive platform trial that sequentially tests multiple clinical questions and personalised algorithms. Methods and analysis BEATRICE is a nationwide, digitally centralised, multi-arm platform trial conducted via the ‘Resilience Training App’. Eligible participants are adults (aged ≥18 years) with PHQ-8 ≤14, fluent in Japanese, owning a smartphone and not currently receiving mental health treatment. Recruitment takes place through health-insurance associations, companies, municipalities and online outreach. Participants are randomised centrally to CBT skill modules—behavioural activation, assertion training, behaviour therapy for insomnia, cognitive restructuringor problem-solving—delivered alone or in combination. Assessments are open-label and completed digitally by self-reports. The initial list of clinical questions to be examined in this platform trial includes: external validity of the personalised and optimised algorithm for first-line interventions, strategies to help individuals not on track during initial weeks, second-line interventions at 6 months, development of super-personalised and optimised therapy algorithm, that is, longitudinally personalised and optimised in response to individuals’ responses after the first-line assignment. The primary outcomes, sample sizes and statistical analyses differ depending on the clinical question addressed within the platform trial. Ethics and dissemination Approved by the Ethics Committee of Kyoto University Graduate School of Medicine (C1733). Results will be disseminated via peer-reviewed publications, conferences and public reports. Trial registration number UMIN000058696.

Background: Children and adolescents with autism spectrum disorder (ASD) frequently experience sleep problems. Although various pharmacological, behavioral, and physical interventions have demonstrated efficacy in improving sleep among children with ASD, the relative effectiveness of these interventions remains unclear. Methods: We will conduct a systematic literature search to identify randomized controlled trials that evaluate the efficacy of pharmacological (e.g., melatonin), psychological (e.g., cognitive behavioral therapy), and physical (e.g., bright light therapy) interventions for sleep problems in children with ASD. We will search PubMed, PsycINFO, Cochrane CENTRAL, major trial registries, and regulatory agency websites. We will assess the Cochrane Risk of Bias 2.0 (RoB 2.0) tool for primary outcome and the Risk Of Bias due to Missing Evidence in Network meta-analysis (ROB-MEN) tool for the bias due to missing network evidence. A network meta-analysis (NMA) will be performed to compare the included interventions. The primary outcome will be sleep onset latency, while secondary outcomes will include other sleep variables, all-cause dropouts, and sleep disturbances assessed using standardized measures. We will assess confidence in NMA(CINeMA). Discussion: Our NMA aims to provide evidence-based insights into the effectiveness of sleep interventions for clinicians, children with ASD, and their caregivers. This information will help guide treatment decisions and improve the quality of life for children with ASD and their families. Systematic review registration: PROSPERO CRD42024592795.

Introduction Perinatal depression poses substantial risks to both mothers and their offspring. Given its chronic and recurrent nature, developing effective prevention strategies is crucial. Internet-based cognitive–behavioural therapy (iCBT) has shown promise. However, the efficacy of specific CBT skills and the influence of individual differences remain unclear. Methods and analysis This protocol describes two harmonised multicentre, open-label, six-arm randomised controlled trials. Across both trials, a total of 2400 pregnant women between 10 and 20 weeks of gestation will be enrolled. After completing psychoeducation (PE), participants will be randomised to either the control condition (PE only) or one of five CBT programmes: behavioural activation (BA), assertion training, BA+cognitive restructuring, BA + problem solving or BA + behaviour therapy for insomnia. The objectives of the study are: (1) to ascertain that the iCBT approach is effective in perinatal depression, (2) to identify active CBT skills for perinatal women and (3) to examine interactions between these CBT skills and individuals’ baseline characteristics to find personalised and optimised therapy for individual women. The primary outcome is the point prevalence of depression at 1 month postpartum, defined as scoring of 9 or higher on the Edinburgh Postnatal Depression Scale. Ethics and dissemination The study has been approved by the Kyoto University Graduate School of Medicine Ethics Committee (C1710) and Nagoya City University Certified Review Board (2024A007). Anonymised study results will be presented at conferences and published by the investigators in peer-reviewed journals. Trial registration number jRCTs042240162 (hospital-based, on-site trial) and jRCT1050250074 (nationwide online trial).

Subthreshold depression, defined as a depressive status falling short of the diagnostic threshold for major depression, is common, disabling and constitutes a risk factor for future depressive episodes. Cognitive behavioral therapies (CBT) have been shown to be effective but are usually provided as packages of various skills. Little research has been done to investigate whether all their components are beneficial and contributory to mental health promotion. We addressed this issue by developing a smartphone CBT app that implements five representative CBT skills (behavioral activation, cognitive restructuring, problem solving, assertion training and behavior therapy for insomnia), and conducting a master randomized study that included four 2 × 2 factorial trials to enable precise estimation of skill-specific efficacies. Between September 2022 and February 2024, we recruited 3,936 adult participants with subthreshold depression. Among those randomized, the follow-up rate was 97% at week 6 and adherence to the app was 84%. The study showed that all included CBT skills and their combinations differentially beat all three control conditions of delayed treatment, health information or self-check, with effect sizes ranging between −0.67 (95% confidence interval: −0.81 to −0.53) and −0.16 (−0.30 to −0.02) for changes in depressive symptom severity from baseline to week 6, as measured with the Patient Health Questionnaire-9 scores. Knowledge of the active ingredients of CBT can better inform the design of more effective and scalable psychotherapies in the future. (UMIN Clinical Trials Registry UMIN000047124).

Background: Internet-based cognitive behavioral therapy (iCBT) shows promise in the prevention of depression. However, the specific iCBT components that contribute to its effectiveness remain unclear. Objective: We aim to evaluate the effects of iCBT components in preventing depression among university students. Methods: Using a smartphone cognitive behavioral therapy (CBT) app, we randomly allocated university students to the presence or absence of 5 different iCBT components: self-monitoring, behavioral activation, cognitive restructuring, assertiveness training, and problem-solving. The active intervention lasted 8 weeks but the app remained accessible through the follow-up. The primary outcome was the onset of a major depressive episode (MDE) between baseline and the follow-up after 52 weeks, as assessed with the computerized World Health Organization Composite International Diagnostic Interview. Secondary outcomes included changes in the 9-item Patient Health Questionnaire, 7-item General Anxiety Disorder, and CBT Skills Scale. Results: During the 12-month follow-up, 133 of 1301 (10) participants reported the onset of an MDE. There were no significant differences in the incidence of MDEs between the groups with or without each component (hazard ratios ranged from 0.85, 95% CI 0.60‐1.20, for assertiveness training to 1.26, 95% CI 0.88‐1.79, for self-monitoring). Furthermore, there were no significant differences in the changes on the 9-item Patient Health Questionnaire, 7-item General Anxiety Disorder, or for CBT Skills Scale between component allocation groups. However, significant reductions in depression and anxiety symptoms were observed among all participants at the 52-week follow-up. Conclusions: In this study, we could not identify any specific iCBT components that were effective in preventing depression or the acquisition of CBT skills over the 12-month follow-up period, but all participants with and without intervention of each iCBT component demonstrated significant improvements in depressive and anxiety symptoms. Further research is needed to explore the potential impact of frequency of psychological assessments, nonspecific intervention effects, natural change in the mental state, and the baseline depression level.