Actively Recruiting
Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS?
Led by Universiteit Leiden · Updated on 2025-11-10
126
Participants Needed
3
Research Sites
165 weeks
Total Duration
On this page
Sponsors
U
Universiteit Leiden
Lead Sponsor
R
Reha Rheinfelden
Collaborating Sponsor
AI-Summary
What this Trial Is About
People with Multiple Sclerosis (MS) often experience cognitive difficulties such as memory problems, concentration issues, and reduced processing speed. These symptoms can have a negative impact on daily functioning and overall quality of life. Previous research on cognitive rehabilitation has shown that regular training focused on memory and concentration can have positive effects on cognitive functioning, including processing speed, memory, and executive functions that support daily activities. Moreover, fMRI studies (brain scans that measure brain activity) have revealed changes in brain activation following cognitive rehabilitation. Recently, the idea has emerged that a more personalized approach could improve treatment outcomes. Specifically, researchers have identified a link between personality traits and cognitive functioning. Since every individual is different, current cognitive rehabilitation programs often fail to take these personal differences into account. In this project, the investigators aim to enhance the effectiveness of cognitive rehabilitation by focusing more closely on individual characteristics through an app-based training program. Participants will complete a 12-week app training prior to a 6-week cognitive rehabilitation program. The first app focuses on mindset training, supported by a coach. Afterwards, all participants will use a second app designed to train processing speed and memory. In addition to cognitive functioning, the investigators will also examine psychological, (neuro)biological, and social changes using questionnaires and fMRI. This research may provide valuable insights into how cognitive functioning and quality of life in people with MS can be improved. This study is funded by the National MS Fund and is a collaboration between several institutions: the Department of Health, Medical and Neuropsychology at Leiden University (The Netherlands), the University at Buffalo (USA), and Reha Rheinfelden (Switzerland).
CONDITIONS
Official Title
Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of relapsing remitting or secondary progressive multiple sclerosis according to McDonald 2017 criteria
- Expanded Disability Status Scale (EDSS) score less than 7
- Relapse-free period of at least 3 months
- Unchanged disease modifying therapy for at least 2 months before inclusion
- Age between 18 and 65 years
- Able to speak Dutch, English, or German depending on study center location
You will not qualify if you...
- High conscientiousness with a T score of 65 or higher on the BFI-2 subscale for conscientiousness
- Current or prior brain trauma or neurological condition other than multiple sclerosis
- Psychiatric disorder significantly affecting cognitive or daily functioning
- Medication use or substance abuse affecting cognitive function
- For Dutch participants undergoing MRI: contraindications for MRI
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo
Buffalo, New York, United States, 14203
Not Yet Recruiting
2
Health, Medical and Neuropsychology, Institute of Psychology, Faculty of Behvavioural and Social Siences, Leiden University
Leiden, Netherlands, 2333AK
Actively Recruiting
3
Research Department, Reha Rheinfelden
Rheinfelden, Switzerland, 4310
Not Yet Recruiting
Research Team
C
Charlotte C Rouzee, MSc
CONTACT
M
Marit FL Ruitenberg, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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