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Breast screening uptake remains low in parts of the UK, partly due to barriers including limited transport access. Offering free transport to screening appointments may help address this and improve uptake. This general practitioner (GP) cluster-randomised feasibility trial will assess whether offering free door-to-door transport alongside routine screening invitations increases attendance.
Eight general practices in Yorkshire will be randomised to either the intervention (routine invitation plus information about booking free door-to-door transport) or control (routine invitation only) group. Around 8000 women due for routine breast screening will be included. Primary feasibility outcomes include GP recruitment and randomisation, intervention fidelity, proportion of women from the 10% most deprived areas, acceptability and data transfer processes. Secondary outcomes include understanding travel behaviour, cost-effectiveness and screening uptake. Data will be collected from routine National Health Service (NHS) screening records, data linkage with NHS England, travel surveys and qualitative interviews exploring experiences and acceptability. Patient and public involvement is embedded throughout with members contributing to advisory and oversight roles.
The trial has received ethical approval from the London–Harrow Research Ethics Committee, Section 251 approval from the Confidentiality Advisory Group and other relevant regulatory bodies. The University of Hull is the study sponsor. Results will be disseminated through peer-reviewed journal publications, conference presentations and plain English summaries for participants and the public. Findings will inform the feasibility and design of a potential larger trial to improve breast screening uptake via transport support.
by Thea Lynne Hedemann, Yun Lu, Sofia Campitelli, Lisa D. Hawke, Nelson Shen, Sarah Saperia, Brett D. M. Jones, Gillian Strudwick, Chelsey R. Wilks, Wei Wang, Marco Solmi, Michael Grossman, Muhammad Ishrat Husain, Nicole Kozloff, George Foussias, Muhammad Omair Husain
BackgroundYouth at clinical high risk (CHR) for psychosis often experience emotional dysregulation, psychiatric symptoms, substance use, suicidality, and functional impairment. Dialectical behaviour therapy (DBT) is an evidence-based intervention that improves emotion regulation, clinical outcomes, and functioning across psychiatric populations. Digital adaptations (d-DBT) may enhance accessibility and engagement for CHR youth, but acceptability and potential benefits in this group are unknown.
ObjectiveTo adapt d-DBT for CHR youth and evaluate the acceptability of delivering it to this population, as well as the feasibility of a larger-scale clinical trial.
MethodsThis mixed-methods clinical trial has two phases. In Phase 1, d-DBT will be adapted for CHR youth in collaboration with a lived-experience youth advisory group. In Phase 2, an assessor-masked randomized controlled trial will compare d-DBT (n = 30) with treatment as usual (n = 30). The intervention consists of eight weekly modules, with primary outcomes assessing acceptability, usability, and trial feasibility. Secondary outcomes include changes in emotional dysregulation, psychiatric symptoms, substance use, suicidality, and functioning.
ConclusionsWe anticipate that d-DBT will be acceptable to CHR youth and that conducting a larger trial will be feasible. Preliminary findings may demonstrate improvements in emotion regulation, psychiatric symptoms, suicidality, and functioning. Results will guide further refinement of the intervention and inform the design of a confirmatory clinical trial.
Trial registrationClinicalTrials.gov #NCT06928935
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