Optimising the prevention, detection and management of diabetes distress in adults with type 1 diabetes: Feasibility study protocol (D-stress feasibility study).

Introduction Diabetes distress describes the psychological and emotional burden of living with diabetes and is associated with reduced self-management and adverse diabetes outcomes. Clinical guidelines recommend routine assessment and management of diabetes distress, but this is not always implemented. Therefore, there is a need to develop approaches to deliver emotional health support in routine clinical care more effectively. We describe here the protocol for a study to I) assess the feasibility of implementation of the D-stress Pathway, comprising Enhanced Usual Care (EUC) and an online, group-based, psychological diabetes distress reduction intervention called REDUCE, ii) evaluate the feasibility of the study protocol iii) detect an effect signal of diabetes distress score and Interstitial Glucose Time in Range and iv) refine initial programme theories of how both interventions (EUC and REDUCE) work, for whom, and under what circumstances. Methods This feasibility study includes a multicentre trial within a cohort design (TWICs) where sites have a staggered exposure to the interventions alongside a realist process evaluation. Four UK NHS diabetes services will recruit 80 adults with type 1 diabetes ([≥]1 year) using continuous glucose monitoring (CGM) ([≥]3 months). All participants will receive EUC and provide monthly data over 7 months on diabetes distress (measured by the Type 1 Diabetes Distress Assessment System (T1DDAS) and interstitial glucose measured by using continuous glucose monitoring. Participants with elevated diabetes distress, will be offered the six-week, group-based, online REDUCE intervention plus EUC, compared to EUC alone. Up to twenty participants with type 1 diabetes, ten family members/friends, sixteen healthcare professionals delivering EUC and five REDUCE facilitators will be interviewed to explore their experience of receiving training and delivering the D-stress Pathway. Up to 20 EUC consultations and REDUCE sessions will be observed. Analysis Feasibility will be assessed against pre-specified progression criteria and analysed descriptively using summary statistics. Primary outcomes include baseline level of diabetes distress, recruitment rate, intervention uptake, and data completeness, which will be analysed descriptively. Qualitative data will be analysed using framework analysis guided by realist programme theories developed for this study. Ethics Ethics approval has been granted by NHS Research Ethics Committee (REC) (Bromley REC: 25/LO/0469) and Health Research Authority obtained. All participants will provide informed consent. Trial registration no: Registered at ClinicalTrials.gov number NCT07193446 on 26/11/2025. Protocol and statistical analysis plan: The trial protocol and statistical analysis plan can be accessed at ClinicalTrials.gov.