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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-67
SponsorAmsterdam UMC, location VUmc

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

270 Participants
are divided into 3 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