A real-world longitudinal study to implement digital assessment and treatment for psychological distress in multiple sclerosis (MS): The COMPASS-MS study protocol (Preprint)

BACKGROUND Comorbid anxiety and depression in Multiple Sclerosis (MS) are common, and confer greater risk of poorer outcomes and increased healthcare utilisation and costs. Currently, few MS services include scalable treatment pathways for psychological distress. This real-world longitudinal study evaluates the implementation of a new integrated pathway including digital screening for psychological distress and COMPASS-MS and a therapist-guided, digital cognitive behavioural therapy (CBT) tailored to challenges of living with MS. OBJECTIVE This protocol describes a mixed-methods, observational, real-world, longitudinal study in the UK (Trial registration: NCT06222359). METHODS This protocol describes a mixed-methods, observational, real-world, longitudinal study in the UK (Trial registration: NCT06222359). Routine mental health screening in the MS clinic will identify patients with distress (using pre-defined clinical cut-offs), who will be assessed for eligibility for psychological treatment, including the COMPASS-MS programme. Participants will receive COMPASS-MS online over approximately 12 weeks (including up to 6 × 30-min therapist sessions). The implementation, reach and adoption of the treatment pathway within a specialist MS service will be assessed using aggregate data on uptake of mental health screening, eligibility, and consent rates for COMPASS-MS, and the number of COMPASS-MS sessions completed. Interviews with patients and healthcare professionals will primarily assess the scalability and potential or actual barriers and facilitators of the new pathway. Potential effectiveness will be assessed using participant questionnaires at pre-intervention and 12 weeks (post-intervention). The primary effectiveness outcome will be pre-post changes in distress (PHQ-ADS scores). Quantitative data will be summarised using descriptive statistics and mixed effects models. Qualitative data will be analysed using reflexive thematic or framework analysis. RESULTS Patient recruitment was completed by September 2025, while recruitment of healthcare professionals is expected to be completed by August 2026. CONCLUSIONS Study findings will inform treatment pathways that can be incorporated into MS clinics, and highlight adaptations or implementation protocols required to increase future scalability and effectiveness. CLINICALTRIAL ClinicalTrials.gov Trial registration: NCT06222359