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).

Children with bilateral cerebral palsy (BCP) frequently develop progressive gait impairments driven in part by muscle weakness. Although power training, which involves high-velocity loaded movements, can enhance functional capacity, its substantial physical demands often limit feasibility in this population. Blood flow restriction (BFR) training has emerged as a promising alternative, capable of eliciting comparable physiological benefits while using low-intensity exercise. This study evaluates the feasibility, safety and clinical effects of integrating BFR with treadmill training in children with BCP, an innovative approach that may deliver the advantages of intensive strengthening while reducing physical burden.

This single-centre pilot study uses a double-baseline design with 13 participants with BCP (Gross Motor Function Classification System II-III), aged 8–18. The protocol consists of a 10-week usual care period followed by a 10-week Blood Flow Restriction Treadmill Training (BFR-TT) intervention, with three sessions per week. Feasibility targets were defined as completion of at least 80% of at least 80% of sessions. Safety is monitored through pain scales and adverse events. Outcomes assess body function (strength, GAITRite), activity (walking speed, walking endurance and motor function) and participation (daily activities), comparing changes between the usual care and BFR-TT periods.

This study was approved by the French Protection of Persons Committee (2024-A00791-46). Results will be published in peer-reviewed journals and presented at international conferences.

NCT06533956.

Chronic low back pain (CLBP) is a leading cause of disability worldwide, significantly affecting patients’ quality of life. Functional restoration programmes (FRPs) are recommended to improve functional abilities and alleviate kinesiophobia, but the integration of emerging technologies like immersive virtual reality (VR) remains underexplored. VR has shown potential in reducing pain and enhancing motor imagery (MI), but its application in group-based rehabilitation for CLBP is novel. This study protocol aims to assess the feasibility and acceptability of adding immersive VR to multicentre FRPs for CLBP.

This multicentric, prospective, single-arm exploratory pilot study assesses the acceptance of incorporating an immersive VR headset into FRP for patients with CLBP. Participants will include healthcare providers and patients from centres in the Lombaction network. Patients will engage in standard FRP alongside three weekly VR sessions targeting trunk mobility and pain reduction. The primary objective is to evaluate the acceptance of the VR device among healthcare providers and patients (Unified Theory of Acceptance and Use of Technology 2-based questionnaire). Secondary outcomes include acceptability, usability (System Usability Scale), adherence, safety and effects on kinesiophobia, MI, pain levels and functional capacities. Data collection includes baseline and post-intervention questionnaires, adherence monitoring and standardised scales (eg, Tampa Scale for Kinesiophobia, Dallas Pain Questionnaire).

Ethical approval was granted by Comité de Protection des Personnes Sud-Est VI on 10 January 2025; all participants will provide written informed consent. Results will be disseminated through peer-reviewed publications, conference presentations and summaries to participating centres.

NCT06724679.

Obesity disproportionately affects ethnic minority populations due to structural inequalities, such as limited access to healthy food, inadequate healthcare and systemic racism. Universal weight management programmes often fail to meet the unique needs of ethnic minority populations. These universal interventions may lead to lower engagement and poorer health outcomes compared with those observed in non-minoritised ethnic groups. This systematic review will examine the impact of culturally tailored interventions to treat and manage obesity in adult ethnic minority populations on weight- and health-related outcomes (meta-analysis) and patient experience (qualitative evidence synthesis).

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. Interventions of interest will include standalone or multicomponent behavioural interventions with culturally tailored elements of design or delivery. These will be compared against standard weight management interventions or usual care in adults from ethnic minority populations living with obesity. The primary outcome is the mean percentage weight (kg) change between pre–post interventions. A search of databases (Ovid MEDLINE, Embase, APA PsycINFO, Scopus and Web of Science) was conducted in February 2025. Eligible studies include randomised controlled trials (RCTs), quasi-experimental (non-randomised trials, pre–post interventions) and qualitative research. Risk of bias will be assessed with the Cochrane Risk of Bias 2 tool and the Mixed Methods Appraisal Tool. Narrative synthesis will be performed according to the synthesis without meta-analysis guidelines. For eligible RCTs, a random-effects meta-analysis will calculate pooled effect sizes between pre–post intervention using standardised mean differences, with additional sensitivity and subgroup analyses. Qualitative evidence synthesis will be performed using semi-automated text analytics (unsupervised machine learning) and inductive thematic analysis.

Ethical approval is not required. Findings will be disseminated through peer-reviewed journal publications, conference presentations, professional organisations and patient and public networks.

CRD42025636750.

Vaccination has been an effective public health intervention for immunising individuals against many common communicable and non-communicable diseases. However, there is limited information on the efficacy of vaccination among patients undergoing dialysis or patients with chronic kidney disease (CKD). The objective of this review is to assess the effectiveness of vaccination within dialysis and CKD patient populations.

This will be a systematic review of studies assessing the effectiveness of vaccination among CKD and dialysis patients. Relevant studies will be identified using MEDLINE, Embase, Scopus and Cochrane Library. All searches will be conducted from database inception to October 2025. Only observational studies such as cohort, prospective, retrospective and cross-sectional studies will be included. Data pertaining to patient outcomes and study design will be extracted. A narrative synthesis will be conducted as well as a meta-analysis if data permitting this analysis is extracted from included studies.

Since data collection will be conducted by examining existing studies, no ethical approval or consent will be required. The results of this review will be published in a peer-reviewed journal as well as presented at seminars, conferences and symposiums.

This review protocol has been registered in International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42025648534.

Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) is an intensive rehabilitation programme for children with cerebral palsy (CP) delivered in a day camp setting recognised to promote the acquisition of specific functional abilities and independence. Currently, during HABIT-ILE camps, families are minimally involved in their child’s motor learning processes. This explains the challenges reported by both families and therapists, including difficulties in reinforcing skills at home, limited transfer to other functional goals and a lack of confidence in parents’ adaptive competence (self-determination and empowerment). Increasing family involvement in intensive motor rehabilitation programmes and the child’s developmental process by reinforcing skills at home could help reduce the parental impact of the child’s disability, enhance family satisfaction and strengthen their resources to support their child’s daily learning during and after the camp.

To address this, we developed the PARTNER programme, which combines HABIT-ILE with a structured home component focused on parent coaching.

We designed a non-inferiority, mixed-methods, multicentre randomised controlled trial to compare the efficacy at 3 months of the PARTNER programme (35 hours HABIT-ILE+15 hours home programme) with the standard HABIT-ILE programme (50 hours) on the bimanual performance (Assisting Hand Assessment) of children with unilateral CP aged 3–5 years. The secondary aims are to compare the 3-month efficacy of the programmes on occupational performance, functional skills and upper limb activity levels, as well as families’ resources, the parent–child relationship, the quantity and quality of resources available in the home to stimulate the child’s motor development, and parental perceptions of their child’s disability and their child’s abilities (qualitative study). The tertiary aim is to conduct a cost-effectiveness analysis of care consumption in each group up to 6 months after the end of the programmes.

Target recruitment is 66 children (33 in each group) from 3 centres in France. Outcomes will be evaluated before the interventions, immediately after, at 3 months and up to 6 months for the cost-effectiveness analysis. Families in the PARTNER group will receive specific coaching and extensive support to perform the home programme. The coaching will focus on enhancing their resources.

The study protocol has been reviewed, and ethics approval obtained from the Protection of Persons Committee (PPC) (PPC number: 2024-A01051-46). The results from this study will be actively disseminated through manuscript publications and conference presentations.

NCT06963151.