Testing two programs to protect thinking and work in multiple sclerosis
Compares two behavioral programs with usual care in adults with multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis
Key facts
- Where
- Amsterdam, NetherlandsSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 67 years old?
Source: NCT06068582, who can take part
Where in Netherlands
- Amsterdam University Medical Centers, location VUmcAmsterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam UMC, location VUmc
- Trial code
- NCT06068582
- Record updated
- 3 April 2025
- Original description
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:Read full original descriptionShow less
Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis
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.
Inclusion: 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: currently on sick leave for a period of 6 weeks or longer; 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 pregnant.