NCT07225868 · Universiteit Leiden
Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS?
What this study 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.
View original scientific description
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).
Interventions
BEHAVIORAL
Conscientiousness Coaching Before Cognitive Rehabilitation
In this arm, participants complete the conscientiousness coaching before the cognitive rehabilitation. All participants (both arms) will receive 6 weeks of cognitive rehabilitation using BrainHQ (2 times per week, 1 hour each).
BEHAVIORAL
Sham Intervention Before Cognitive Rehabilitation
In this arm, participants complete the sham intervention before the cognitive rehabilitation. All participants (both arms) will receive 6 weeks of cognitive rehabilitation using BrainHQ (2 times per week, 1 hour each).
Primary outcome measures
Objective cognitive changes between baseline and post-intervention
Time frame: Between baseline and week 18.
Objective cognitive changes between baseline and post intervention will be assessed using the Symbol Digit Modalities Test assessing information processing speed.
Subjective cognitive changes between baseline and post-intervention
Time frame: Between baseline and week 18.
Subjective cognitive changes between baseline and post intervention will be assessed using the Multiple Sclerosis Instrumental Activities of Daily Living Questionnaire.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Confirmed relapsing remitting or secondary progressive MS diagnosis according to the McDonald 2017 criteria
- Expanded Disability Status Scale (EDSS) score \< 7
- Relapse free period ≥ 3 months
- Unchanged disease modifying therapy for ≥ 2 months at time of inclusion
- Age 18-65 years
- Language Dutch, English or German for each centre respectively
Exclusion criteria
- High conscientiousness, measured with a T score 65 or higher on the BFI-2 subscale for conscientiousness
- Current or prior brain trauma or neurological condition (other than MS)
- Psychiatric disorder that heavily impacts cognitive and/or daily functioning
- Medication intake and/or substance abuse that has an influence on cognitive functioning
- For Dutch subsample undergoing MRI: Contradiction for MRI
Where
- Buffalo, New York
Collaborators
Reha Rheinfelden, University at Buffalo
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations