A cluster-randomised controlled feasibility trial evaluating the Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS)

Abstract

Abstract Introduction: There is a high prevalence of cognitive difficulties in MS, but despite this, there are few programmes targeting cognition that focus on the ability to function well in everyday life. The Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS), an occupation-focused cognitive intervention, was developed to address this. It focuses on both the functional difficulties and the wide-ranging symptoms that present in MS. Objective: Here we report on the results of a cluster-randomised controlled feasibility trial (ISRCTN11462710; registered 4th September 2019) evaluating the COB-MS in terms of feasibility and initial efficacy as a cognitive intervention for people with MS. Method: Data was collected from people with MS experiencing cognitive difficulties at baseline, post-intervention, 12-weeks, and 6-month follow-up. The primary outcome measure was the Goal Attainment Scaling at 12 weeks. Data was also collected in cognition, quality of life, and mood. Results: One hundred and eighteen people with MS and cognitive difficulties were randomised to either usual care (n=60) or COB-MS intervention (n=58). Ninety-four participants were retained at 6-month follow-up. Those allocated to the COB-MS group had a significant improvement in the primary outcome compared to the control condition. The COB-MS was found to be feasible, including trial procedures and protocol. Data indicates that the COB-MS is accepted by participants and had positive impacts on daily life. Progression criteria have been met. Conclusion: The results provide a strong basis for a pathway to a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy.