Guided parent-delivered cognitive behavioural therapy (GPD-CBT) is an evidence-based, low-burden treatment programme for childhood anxiety disorders with demonstrated efficacy, cost-effectiveness and accessibility. However, it has been tested primarily in Western countries, and the efficacy and cost-effectiveness have not been evaluated in Japanese families. The current study aims to examine GPD-CBT’s efficacy and cost-effectiveness in Japanese samples and explore potential cultural adaptations of the programme.

This study is designed as a Bayesian single-blind randomised controlled trial with two parallel groups: GPD-CBT (intervention group) and a waitlist control group. The primary outcome is remission of primary anxiety disorders evaluated through diagnostic interviews by independent evaluators. Secondary outcomes include child and parent-reported child anxiety symptoms, depressive symptoms and life interference. Additionally, measures of parental psychological characteristics, programme acceptability and quality of life are collected. We will conduct qualitative interviews with parents who participated in the programme and therapists who delivered the intervention to explore potential cultural adaptations. We aim to recruit 54–170 families, depending on the results of sequential Bayesian analyses. GPD-CBT consists of seven weekly 20 min sessions and a 1-month follow-up session. Assessments will be conducted at baseline, 13 weeks post randomisation (primary endpoint for between-group comparison), with an additional 25 weeks post randomisation. The waitlist control group will receive GPD-CBT after the 13-week assessment.

This study has been approved by the Ethics Review Committees of Chiba University and the University of Tokyo. We will disseminate results through academic conference presentations and peer-reviewed journal publications. If the GPD-CBT intervention proves efficacious, we will promote wider implementation in Japan through the development of training programmes for mental health professionals and key stakeholders.

jRCT1032250421 (https://jrct.mhlw.go.jp/latest-detail/jRCT1032250421) and jRCT1030250422 (https://jrct.mhlw.go.jp/latest-detail/jRCT1030250422) registered on 9 October 2025.

Eisenmenger syndrome and pulmonary arterial hypertension (PAH) due to unrepaired congenital shunts, including atrial septal defect (ASD), ventricular septal defect (VSD) and patent ductus arteriosus (PDA), remain life-threatening conditions despite advances in congenital heart disease (CHD) care. In this population, vasodilator-based therapies effective in other forms of PAH have shown limited benefit, and no disease-modifying treatment has been established. Sotatercept, an activin-signalling inhibitor, improved exercise capacity and haemodynamics in phase 2/3 PAH trials; however, patients with unrepaired CHD, including Eisenmenger syndrome, were excluded. The efficacy and safety of sotatercept in this population remain unknown.

The SuMILE trial is a prospective, exploratory, multicentre, open-label, randomised, controlled trial conducted at 11 Japanese tertiary centres. 36 adults with vasodilator-resistant PAH due to unrepaired ASD, VSD or PDA, including Eisenmenger syndrome, will be randomised 2:1 to sotatercept add-on therapy plus vasodilator-based PAH therapy versus vasodilator-based PAH therapy alone. Sotatercept will be administered subcutaneously every 3 weeks in accordance with label-approved dose-modification rules for haemoglobin and platelet changes. The primary endpoint is the change in 6-min walk distance from baseline to week 24. Key clinical events will be independently adjudicated. Secondary endpoints include all-cause mortality or lung transplantation; pulmonary hypertension-related hospitalisation or initiation of parenteral prostacyclin and changes in WHO functional class, N-terminal pro-brain natriuretic peptide and emPHasis-10. Exploratory endpoints include genotype, right heart catheterisation and cardiac MRI parameters. The primary analysis will use ANCOVA, adjusting for baseline 6-min walk distance and randomisation stratum in the intention-to-treat population.

The protocol has been reviewed and approved by the certified central review board (Kyushu University Hospital Clinical Ethics Review Board) and participating institutions. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, scientific conferences and trial registries.

Japan Registry of Clinical Trials no. 1071250069; ClinicalTrials.gov NCT07356778. Protocol version and date: V.1.3; 23 October 2025

To evaluate the impact of Japan’s COVID-19 state of emergency declarations on percutaneous coronary intervention (PCI) volumes using Seasonal AutoRegressive Integrated Moving Average with eXogenous variables (SARIMAX) modelling. This model offers methodological advantages by: (1) accounting for trends, seasonal variations and autocorrelation; (2) allowing the introduction of policy intervention periods as binary exogenous variables; and (3) enabling an accurate assessment of healthcare impacts during intermittent declaration phases while accounting for periods of subsidence.

Retrospective observational study using a SARIMAX model.

1377 acute care hospitals participated in Japan’s Diagnosis Procedure Combination (DPC) system between April 2018 and December 2021.

All patients who underwent emergency PCI (n=176 878) or elective PCI (n=272 811) during the study period, identified from a nationwide administrative database.

This study analysed the impact of Japan’s COVID-19 state of emergency declarations as policy intervention periods, which were implemented during four waves (April to May 2020, January to March 2021, May to June 2021 and July to September 2021). Months where more than half of the days fell within a state of emergency declaration were defined as intervention periods.

Primary outcome measures were nationwide changes in both emergency and elective PCI volumes during state of emergency periods compared with non-emergency periods, analysed through SARIMAX modelling. Secondary outcomes included regional analyses of changes in both types of PCI volumes across eight geographical regions of Japan and the distribution analysis of medical resources (DPC hospitals, hospital beds, physicians and board-certified cardiologists per million population) in each region.

Nationwide, emergency PCI volumes totalled 176 878 and elective PCI volumes 272 811 over the 45-month study period. SARIMAX modelling indicated that the state of emergency declarations were associated with significant reductions in both emergency PCI volumes (–211.4 cases/month, 95% CI –326.9 to –95.9; –5.4%) and elective PCI volumes (–632.4 cases/month, 95% CI –1045.9 to –219.0; –10.4%). Regional analyses showed varied effects, with some areas (eg, Hokkaido, Shikoku, Kyushu) experiencing non-significant volume decreases, potentially reflecting differences in medical resource distribution and capacity.

The COVID-19 state of emergency declarations in Japan were associated with decreased PCI volumes. Applying SARIMAX models to real-world data could allow us to examine the effects of various events on healthcare considering trends, seasonal variation and autocorrelation by incorporating events as exogenous variables.

Accidental hypothermia (AH) can occur in mild-to-severe cases; however, its management is crucial in severe cases as it can cause ventricular fibrillation and lead to death. Among various rewarming therapies for AH, endovascular catheter rewarming has been the focus of recent studies as a minimally invasive alternative to invasive internal rewarming, such as extracorporeal membrane oxygenation (ECMO). However, no study has demonstrated the efficacy and safety of endovascular catheter rewarming therapy. This study aimed to validate the efficacy and safety of endovascular catheter rewarming for patients with AH.

The intensive care with endovascular catheter rewarming in accidental severe hypothermia (ICE-CRASH II) study is a multicentre, randomised study of patients with AH. This study will include patients with AH (age ≥65 years, core temperature

This study was approved by the Hokkaido University Certified Review Board (approval number: 024-00013). Written informed consent will be obtained from all the participants or their legally acceptable representatives. The results will be disseminated through publications and presentations.

Japan Registry of Clinical Trials (jRCT1012240051).

With an ageing population, prevention of frailty among older adults has become a critical public health issue. Dietary habits are one of the essential components in frailty prevention, which involves promoting changes in dietary behaviours, such as including dietary variety. However, community-level health promotion interventions face significant challenges, including limited spatial access to food, which is important as it is not easy to change the behaviour of older adults. The dissemination of community-level health promotion interventions targeting dietary behavioural changes among older adults remains unclear. Therefore, this study aimed to evaluate the effects of supermarket-based health promotion interventions on dietary variety among older Japanese adults.

This study is a cluster non-randomised parallel-group comparative trial involving 15 supermarkets in the Yamanashi and Nagano Prefectures, Japan. Seven supermarkets will be assigned to the intervention group and eight to the control group. The intervention group will receive a health promotion programme consisting of three components to enhance dietary diversity: information, education and support delivery. The intervention design incorporates social marketing strategies, and programme evaluation will be conducted concurrently. Data, including the Dietary Variety Score (DVS) for the primary outcome, will be collected through postal and electronic surveys at baseline and at 1, 2 and 3 years, with the 3-year follow-up serving as the primary endpoint for effectiveness evaluation. Statistical analyses will use a generalised linear mixed model, focusing on changes in the DVS as the primary outcome. Sensitivity and subgroup analyses will be performed to assess the generalisability of the findings.

The Tokyo Metropolitan Institute for Geriatrics and Gerontology Research Ethics Committee has approved the research protocol (approval number: R23-116). The results will be disseminated through conference presentations and publication in peer-reviewed international journals.

UMIN000056023.