Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07225868

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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