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

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 addresses 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: The eight-session COB-MS intervention was delivered remotely by occupational therapists to participants with MS in the intervention group. Following the end of the trial the COB-MS was delivered to the wait-list control group. 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 the domains of 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. 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. Those allocated to the COB-MS group had a significant improvement in the primary outcome compared to the control condition. Progression criteria set for the feasibility trial have been met therefore further testing of the COB-MS at a definitive trial is supported by the results. 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. Trial Registration: ISRCTN11462710 Date of registration: 4th September 2019.