A Cognitive Occupation-Based programme for people with Multiple Sclerosis: definitive trial (COB-MS)
Multiple sclerosis
An occupational therapy intervention aimed at improving daily life functioning for people with multiple sclerosis (MS) who are experiencing cognitive difficulties. Participants will be allocated to the three arms using an allocation ratio of 1.3 in favour of the intervention arms to allow for clustering of the intervention arm, using randomly permuted blocks. Participants, with a diagnosis of MS and experiencing cognitive difficulties, will be randomly allocated to one of three trial arms, using a partially clustered design: • In-person intervention arm- COB-MS delivered by an occupational therapist in a community setting. • Online intervention arm- COB-MS delivered by an occupational therapist fully online. • Control arm- TAU. Rationale, theory, or goal of the elements essential to the intervention The COB-MS is a patient-centred, holistic programme which consists of eight sessions- two individual and six group-based. It focuses on managing demands of employment and daily life through education, remediation and adaptation using compensatory strategies, routines and learning new techniques that can be integrated into daily contexts. It recognises the impact of emotion, motivation and other non-cognitive functions. The COB-MS looks at the context/environment within which the person lives to make strategies meaningful to the participant. The programme aims to help people meet their goals while managing their cognitive challenges. The group sessions focus on aspects of cognition and cognitive rehabilitation. There is an emphasis on group discussion and peer learning. Participants have a chance to practice strategies in the group and at home. Steps were taken in designing the COB-MS which addressed the maintenance of gains and continuation of strategies developed through the intervention – these include incorporating behaviour change principles into the COB-MS, integrating home activities into weekly routines, providing people with MS with handbooks which de
1. Aged 18 years of age or older 2. Have a diagnosis of multiple sclerosis, consistent with the 2024 McDonald Criteria for the Diagnosis of Multiple Sclerosis 3, Have cognitive difficulties 4. Not currently undergoing any other form of cognitive rehabilitation 5. Fluent in written and spoken English, 6. Not experiencing an active relapse- clinically stable for three months 7. Can provide informed consent 8. Are a resident of the Republic of Ireland
1. Significant cognitive impairment that would affect reliable participation or capacity to give informed consent 2. Significant diagnosed neurological condition or organic brain damage (unrelated to MS)