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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Strenghtening the brain
- Strengthening the mind
Treatment groups
Sponsors and collaborators
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