Strengthening Mental Abilities with Relational Training (SMART) in Multiple Sclerosis (MS): Study Protocol for a Feasibility Randomised Controlled Trial

Abstract Background Multiple Sclerosis (MS) is a chronic condition of the central nervous system, affecting around 1 in every 600 people in the UK, with 130 new diagnoses every week. Cognitive difficulties are common amongst people with MS, with up to 70% experiencing deficits in higher-level brain functions – such as planning and problem-solving, attention, and memory. Cognitive deficits make it difficult for people with MS to complete everyday tasks and limit their abilities to work, socialise, and live independently. There is a clear need – and recognised research priority – for treatments that can improve cognitive functioning in people with MS. The absence of effective cognitive interventions exacerbates burdens on the services accessed by people with MS – requiring these services to manage sequelae of untreated cognitive deficits, including reduced quality of life, greater disability and dependence, and poorer adherence to disease-modifying treatments. Our planned research will fill the evidence gap through developing – and examining the feasibility of trialling – a novel online cognitive rehabilitation programme for people with MS (SMART). Methods The primary objective of this study aims to conduct a feasibility study to inform development of a definitive trial of SMART for improving cognitive functioning in people with MS. Secondary objectives include accessing the acceptability to participants of the intervention, delivery format, inclusion/exclusion criteria, baselines and outcome measures, randomisation protocol, and the study procedures. It will further assess the framework for a cost-effectiveness analysis alongside a definitive trial; participant recruitment and retention rates, sample-size needed for a fully powered trial, and signal of efficacy. Discussion As a feasibility trial, outcomes are unlikely to immediately effect changes to NHS practice. However, this is a necessary step towards developing a definitive trial – and will give us a signal of efficacy, a prerequisite for progression to a definitive trial. If found to be clinically- and cost-effective, the latter trial could create a step-change in MS cognitive rehabilitation – improving service-delivery and optimising support with limited additional resources. Trial Registration: Registration ID: ClnicalTrials.gov: NCT04975685 – registered on July 23rd, 2021 Protocol version: 2.0, 25 November 2021