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.

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.

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.

jRCTs042240162 (hospital-based, on-site trial) and jRCT1050250074 (nationwide online trial).

This research paper presents a study protocol for an exploratory clinical trial evaluating the safety and potential efficacy of autologous peripheral blood mononuclear cell (PBMNC)-loaded injectable cell scaffold (ICS-001) for angiogenic therapy in chronic limb-threatening ischaemia (CLTI). CLTI, the advanced stage of peripheral artery disease, presents significant therapeutic challenges.

Angiogenic therapy using ICS-001 with PBMNCs—a novel approach designed to enhance local cell retention and promote neovascularisation—will be explored. The study will address the pathophysiology of CLTI, the limitations of current treatments and the rationale for cell-based therapies, alongside the clinical trial design for evaluating the safety and efficacy of ICS-001. We hypothesise that ICS-001 will improve ulcer healing and reduce ischaemic rest pain in patients with CLTI. This paper outlines the methodology, including patient selection, CD34⁺ cell mobilisation, scaffold preparation, injection protocols, clinical assessments, data collection and safety monitoring. The anticipated results, discussion and conclusion will offer insight into the clinical significance and potential impact of ICS-001 as a pioneering angiogenic therapy for CLTI.

The institutional review boards of all participating hospitals approved this study protocol (latest version V.6.0, 5 June 2025). Final data will be made publicly available. A report detailing the study results will be submitted for publication in an appropriate peer-reviewed journal.

Data are available on reasonable request. Technical appendix, statistical code is available by contacting the corresponding author. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) licence, which permits others to distribute, remix, adapt, build on this work non-commercially, and licence their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

jRCT2052230115, Japan Registry of Clinical Trials.

Major depressive disorder (MDD) is among the most common psychiatric disorders in children and adolescents. While previous meta-analyses have synthesised evidence on the efficacy and acceptability of newer-generation antidepressants in this population, specific adverse events (AEs) remain poorly characterised. This is of high clinical importance, as AEs are burdensome for patients, can reduce treatment adherence and lead to discontinuation. Here, we present a protocol for a network meta-analysis designed to evaluate the specific AE profile and comparative tolerability of newer-generation antidepressants in children and adolescents with MDD.

The planned study will include double-blind randomised controlled trials that compared one active drug with another and/or placebo for the acute treatment of MDD in children and adolescents. The following antidepressants will be considered: agomelatine, alaproclate, bupropion, citalopram, desvenlafaxine, duloxetine, edivoxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, vilazodone and vortioxetine. The primary outcomes will include the number of patients experiencing at least one AE, specific non-serious AEs, serious AEs (eg, suicidal ideation) and AEs leading to treatment discontinuation. Published and unpublished studies will be retrieved through a systematic search in the following databases: PubMed, Embase, Cochrane Library (including the Cochrane Central Register of Controlled Trials), Web of Science Core Collection, PsycInfo and regulatory agencies’ registries. Study selection and data extraction will be performed independently by two reviewers. For each outcome, a network meta-analysis will be performed to synthesise all evidence. Consistency will be assessed through local and global methods, and the confidence in the evidence will be evaluated using the Confidence in Network Meta-Analysis web application. All analyses will be conducted in the R software.

The planned review does not require ethical approval. The findings will be published in a peer-reviewed journal and may be presented at international conferences.

CRD420251011399.

The necessity of enhancing resuscitation training has been encouraged by The International Liaison Committee on Resuscitation and the American Heart Association to reduce mortality, disability and healthcare costs. Resuscitation training is a complicated approach that encompasses various components and their mixture. It is essential to identify the most effective of these components and their combinations, to measure the corresponding effect size and to understand which participant groups may enjoy the greatest advantage.

We will systematically search 12 databases and two clinical trial registries for randomised controlled trials (RCTs) that examine different resuscitation training methods from inception to April 2025. The analysis will be carried out using the standard network meta-analysis and component network meta-analysis models. Resuscitation skills of staff will be the primary outcome of this analysis. Paired reviewers will independently screen and extract data. A consensus will be sought with the principal investigators to resolve any disagreements that cannot be achieved through regular meetings. Each intervention in each RCT will be decomposed according to its constituent components, such as delivery method, interactivity, teamwork, digitalisation and type of simulator. The analysis will be conducted using the frequentist and bayesian approach in the R environment. RoB V.2.0 and Confidence in Network Meta-Analysis will, respectively, be used to assess the risk of bias and the certainty of the evidence.

As we will use only aggregated secondary data without individual identities, ethical approval is not required. Results of this review will be shared through a peer-reviewed publication and presentation of papers at any relevant conferences.

CRD42024532878