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RECRUITINGINTERVENTIONAL

Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 mild cognitive deficits (at least one test with a Z-score of -1.0 to -1.99 below norm scores of healthy controls on the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery - being able to participate in an exercise intervention (i.e., EDSS \< 6.0) - fulfilling safety criteria for MRI (no metal inside body, not pregnant, no claustrophobia) Who Should NOT Join This Trial: - 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 - currently pregnant Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 mild cognitive deficits (at least one test with a Z-score of -1.0 to -1.99 below norm scores of healthy controls on the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery * being able to participate in an exercise intervention (i.e., EDSS \< 6.0) * fulfilling safety criteria for MRI (no metal inside body, not pregnant, no claustrophobia) Exclusion Criteria: * 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 * currently pregnant

Treatments Being Tested

BEHAVIORAL

Strenghtening the brain

Lifestyle 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.

BEHAVIORAL

Strengthening the mind

Work-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.

Locations (1)

Amsterdam University Medical Centers, location VUmc
Amsterdam, Netherlands