The goal of this randomized controlled trial is to compare the effectiveness of two innovative interventions aimed at preventing cognitive decline and work-related problems to enhanced usual care in improving quality of life in people with multiple sclerosis. Secondary objectives are:
* to compare the effectiveness of the investigated interventions in improving cognitive, psychological, and work functioning, and in enhancing the brain's functional network * to examine which factors (i.e., baseline cognitive, psychological, work, and brain MRI-parameters) are predictive of the response to the investigated interventions * aim to qualitatively reflect on the process and outcome of the investigated interventions considering the perspectives of relevant stakeholders to allow for smooth and successful implementation in clinical practice
Participants will follow the intervention for four months, with follow-up measurements at six months after intervention and 12 months after intervention.
Confirmed MS diagnosis according to the McDonald 2017 criteria
Age between 18 and 67
No changes in disease modifying therapy prior to inclusion (i.e., no changes in last 3 months) - this criterion only applies at inclusion to ensure participants are in a stable situation at the start of the study and for follow-up measures, changes in treatment will be registered but will not result in exclusion from the study
no current relapse or steroid treatment in the six weeks prior to study visits
presence of neurological (other than MS) and psychiatric disorders
a current or history of drug or alcohol abuse
being unable to speak or read Dutch
currently on sick leave for a period of 6 weeks or longer
Parallel
Strenghtening the brain
BehavioralLifestyle intervention containing physical exercise, lifestyle coaching, and cognitive training. The programme contains weekly 30 minutes 1-on-1 fitness and lifestyle coaching with two moments of exercise at home for 20 minutes. Online computerized cognitive training will be done for 60 minutes per week.
Strengthening the mind
BehavioralWork-focused intervention combining the capability approach and the participatory approach. Together with a work-coach who has been diagnosed with MS themselves, participants will assess important work values, discover challenges participants are facing, think of solutions for these challenges, develop a plan of action and implement these solutions.
Quality of Life
Quality of life assessed using the 36-item Short Form. Item-scores are summed and transformed into a total score that ranges 0-100. Higher score corresponds with better quality of life.
Information processing speed
Information processing speed is assessed using the Symbol Digit Modalities Test (SMDT). The total responses made in 90 seconds is administered. Higher amount of correct responses equals better information processing speed.
Information processing speed
Information processing speed is assessed using the Paced Auditory Serial Addition Test (PASAT). The total correct answers given, out of 60, is administered. Higher amount of correct responses equals better information processing speed.
Verbal fluency
Verbal fluency is assessed using the Dutch adaptation of the Controlled Oral Word Association Test; Dutch Letter Fluency Test. Total number of correct words will be administered. Higher score corresponds with better verbal fluency.
Spatial Processing
Spatial Processing is assessed using the Judgement of Line Orientation. Total correct responses, with maximum 30, will be administered. Higher score corresponds with better spatial processing.
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Amsterdam UMC, location VUmc
Lead sponsor
Universiteit Leiden
Sponsor institution
Universiteit Leiden
Collaborator
Personal Fitness Nederland
Collaborator
MS Vereniging Nederland
Collaborator
Merck B.V., Netherlands
Collaborator
Genzyme, a Sanofi Company
Collaborator
MS Sherpa
Collaborator
