COMBAT-MS (COgnitive reMediation and Behavioural Approaches to Treatment in Multiple Sclerosis)

Randomised, controlled, single-blinded, prospective, longitudinal study to assess psychosocial adjustment, learning and memory in patients with multiple sclerosis treated with a novel therapy combining CBT and Cognitive Remediation. Participants will be randomly assigned to receive either the study intervention for 10 weeks or assigned to receive treatment as usual (usual clinical care by their treating neurologist). Participants across both groups will receive assessments at baseline (prior to study intervention), immediate and long-term follow up. Assessors blinded to participant randomisation will conduct the immediate (3 month) and long-term (12 month) follow up assessments. The study intervention will combine elements of an evidence-based CBT program targeting adjustment in MS (saMS) with evidence-based cognitive-training techniques involving both strategy training and computer-based cognitive training. The cognitive remediation component will be informed by the Neuropsychological Educational Approach to Remediation (NEAR). The delivery of the study intervention will be lead by a Clinical Neuropsychologist with 8+ years of experience in neuropsychological and psychological assessment and the delivery of CBT and cognitive remediation. The intervention will be delivered in a group-based therapy format for two hours a week over one session for 10 weeks. The intervention will be delivered in a university research centre. The therapy will be delivered in small groups of 6-10 people. The content will be shown on slides and presented by the trial psychologists. The format of the sessions will generally follow the following sequence: 1) presentation of psychoeducational content relating to MS, mood, anxiety, stress, and cognition; 2) discussion of how the content relates to the individuals in the group; 3) teaching of strategies to assist with difficulties with mood, anxiety, stress, and cognition; 3) practicing those strategies with a partner from the group. For participants located >40km from the study centre, they will be offered the opportunity to participate in the group intervention remotely via video conferencing. Patients enrolled in the study will receive a participant information statement. They will be asked to complete self-report questionnaires assessing factors associated with psychosocial adjustment. During the intervention, they will receive psychoeducational content in the form of print out of slides. They will be able to refer to this content whenever they wish.The trial psychologists will use a battery of neuropsychological measures from the MACFIMS battery to assess patients. Trial neurologists will utilise the Expanded Disability Status Scale to assess disability in trial participants. We aim to determine whether this program has an impact on psychological factors (i.e. depression, anxiety, stress, coping, self-efficacy, health related quality of life and productivity) and aspects of cognitive functioning (i.e. memory, attention, speed of information processing, executive functions, visuospatial skills) contributing to adjustment. In a randomized controlled design, this will be achieved by administering standardised psychological and neuropsychological assessments pre and post intervention that have been shown to be sensitive in persons with MS. Sustainability of effects will be monitored by repeating these assessments at a 12-month follow-up visit. We also aim to determine whether the program is associated with secondary benefits to pharmacological treatment adherence and disease course (e.g. number of relapses; severity of physical symptoms). A register of attendance at each session will be used to monitor adherence.