Carers of people with non-memory-led dementias such as posterior cortical atrophy (PCA), primary progressive aphasia (PPA) and behavioural variant frontotemporal dementia (bvFTD) face unique challenges. Yet, little evidence-based support and guidance are available for this population. To address this gap in services, we have developed a novel, web-based educational programme: the Better Living with Non-memory-led Dementia programme (BELIDE). BELIDE was co-designed with people with lived experience of non-memory-led dementia and a previous pilot study confirmed its feasibility as an online intervention. This protocol outlines the randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of BELIDE.

This is a parallel-group, single-blind, RCT of 238 unpaid caregivers of people diagnosed with PCA, PPA or bvFTD recruited internationally among members of the UK-based organisation Rare Dementia Support. The intervention (BELIDE programme) consists of six structured online educational modules tailored to each phenotype, a virtual onboarding session, real-life practice tasks and up to two follow-up facilitation sessions. The group receiving the intervention will be given access to the programme, while the control group will receive treatment as usual and be placed on a wait-list to receive access to the programme once they complete their participation in the trial. The allocation ratio will be 1:1 stratified by dementia diagnosis and gender. The primary outcome is reduction in caregiver depressive symptoms. Secondary outcomes include stress, anxiety, self-efficacy, quality of life and caregiver-patient relationship quality. Data will be collected online via Qualtrics surveys at baseline, 8 weeks and 6 months post-randomisation. A mixed-method process evaluation with a subgroup of intervention participants will explore barriers and facilitators for engagement. A health economics evaluation will also be conducted to assess cost-effectiveness. If effective, this programme could improve access to caregiver support for non-memory-led dementias by providing scalable, tailored education.

Ethical approval has been granted by University College London Research Ethics Committee (8545/007). The results will be disseminated via peer-reviewed publications, conferences, stakeholder events and open-access resources.

This trial has been registered prospectively on the Clinical Trials registry, first posted on 5 February 2024 under registration number NCT06241287.

Psychosis, characterised by chronic symptoms often emerging in youth, imposes a substantial burden on individuals and healthcare systems. While early detection and intervention can mitigate this burden, there is limited evidence on the cost-effectiveness of such approaches. To address this lack of evidence, this study protocol outlines the health economic implications of an artificial intelligence (AI)-based intervention, the Computer-Assisted Risk-Evaluation (CARE), designed to prevent psychosis. The intervention uses AI technologies to enhance the diagnosis and treatment quality for individuals at high risk of psychosis.

The health economic evaluation has been designed alongside a 12-month multicentre randomised controlled trial comparing CARE with treatment as usual from both payer and societal perspectives. An implementation cost analysis will complement the evaluation, and long-term consequences beyond the trial will be explored descriptively. Based on a literature review, an initial economic logic model will guide subsequent analyses by depicting CARE’s programme theory.

The cost-effectiveness assessment will include averted cases of manifest psychosis and quality-adjusted life-years using the EuroQol 5-Dimensions 3-Level instrument. Other effectiveness outcomes will also be incorporated into a cost–consequence analysis. Cost-effectiveness acceptability curves reflecting statistical uncertainty will be constructed, incorporating various payer and societal willingness-to-pay values. The implementation cost analysis will follow a mixed-methods approach to capture facility-specific costs.

A dark logic model, emphasising negative outcomes, will be developed to investigate long-term consequences. Further, the initial economic logic model will be refined using trial data and expert interviews. This comprehensive approach aims to provide decision-makers not only with evidence on the cost-effectiveness of CARE, but also with a broader understanding of the implications of the intervention.

The study has received ethical approval and plans to disseminate its findings through publication in a peer-reviewed journal and conference presentations.

NCT05813080.

Adverse events during paediatric anaesthesia are common, with hypoxaemia during the induction period being a leading cause, as infants and children are particularly vulnerable to hypoxaemia during periods of apnoea. The administration of supplementary oxygen, referred to as apnoeic oxygenation, has been shown to prolong safe apnoea times and increase first-pass intubation success rates. Despite these benefits, apnoeic oxygenation is not routinely used in paediatric anaesthesia. Low-flow apnoeic oxygenation, delivered via a standard nasal cannula, is a simple approach to provide supplementary oxygen during paediatric airway management without requiring additional equipment. However, its efficacy in airway management during elective surgeries has not been adequately studied.

The ApOx-Pedi-Trial is a single-centre, cluster randomised, controlled clinical trial comparing the use of low-flow apnoeic oxygenation during the induction of general anaesthesia in infants and children up to 6 years of age undergoing elective surgery at the Department of Pediatric Surgery at Heidelberg University Hospital to standard of care (no apnoeic oxygenation). Randomisation is conducted using a weekly cluster randomisation method, where all patients presenting for surgery in a given week either receive apnoeic oxygenation or standard of care during the induction of general anaesthesia, based on the week’s group allocation.

The study population will consist of two independent, age-stratified cohorts (24 months to 6 years), each including 100 patients. Statistical analysis of study endpoints will be conducted separately for each cohort to allow for age-specific assessment of outcomes.

The primary objective of this trial is to evaluate whether apnoeic oxygenation can prevent a decrease in transcutaneous haemoglobin saturation (SpO₂) during the induction of general anaesthesia in infants and children. The primary outcome measure will be the lowest recorded SpO₂ value throughout the apnoeic period.

The ApOx-Pedi-Trial received permission from the local ethics committee (Ethics Committee of the medical faculty at Heidelberg University, Heidelberg, Germany) under the registration number S-074–2024. The study is following institutional Guidelines and the Declaration of Helsinki of 1975 in its most recent version. Trial results will be submitted to peer-reviewed journals and presented at national and international conferences.

The trial is prospectively registered on ClinicalTrials.gov with the number NCT06576596.

Patients with mental disorders and a history of childhood trauma show an early onset of psychopathology and often a poor response to standard disorder-specific treatments. They represent a patient group which requires more personalised interventions targeting the transdiagnostic mechanisms related to early trauma and its functional consequences. The mechanism-based modular psychotherapy (MeMoPsy) approach is conceptualised as an innovative framework for psychotherapy development. It comprises independent, flexibly applicable interventions from various theoretical backgrounds and evidence-based programmes within a systematic treatment algorithm, thereby tailoring module selection to the specific needs of traumatised adolescents.

In a randomised controlled feasibility trial (RCT), N=80 outpatients between 15 and 25 years of age diagnosed with various mental disorders will receive 28 individual sessions with MeMoPsy or standard cognitive behavioural therapy. MeMoPsy includes a basic module that addresses trauma history and three additional modules focusing on functional impairments known to be associated with childhood trauma: rejection sensitivity, emotion regulation and relationship difficulties. These modules are selected based on a self-report algorithm. Techniques from mentalisation-based therapy, cognitive behavioural analysis system of psychotherapy, dialectical behaviour therapy and systemic therapy are integrated in this personalised modular procedure. This proof-of-concept study aims to provide initial evidence for acceptability, feasibility and changes in self-rated and diagnostician-rated psychopathology (post-treatment and 3 months follow-up) of MeMoPsy and elucidate the mechanisms of change using psychotherapy process research, Ecological Momentary Assessment and functional magnetic resonance imaging (fMRI).

This RCT obtained approval from independent ethics committees of participating centres and is accompanied by a data and safety monitoring board. Findings will be communicated within the research community as well as with patients and the public by the dissemination strategies of the German Center for Mental Health.

German Clinical Trials Register DRKS00034058.