Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS?

Part of paid clinical trials in Buffalo, New York.

Sponsor
Universiteit Leiden
Study ID
NCT07225868
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Conscientiousness Coaching Before Cognitive Rehabilitation — BEHAVIORAL
    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).
  • Sham Intervention Before Cognitive Rehabilitation — BEHAVIORAL
    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).

Study Details

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).

Key Dates

Start date
Nov 1, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Conscientiousness Coaching
  • Sham Comparator: Sham Intervention

Primary Outcome Measure

Objective cognitive changes between baseline and post-intervention [ Time Frame: Between baseline and week 18. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Jacobs School of Medicine and Biomedical Sciences, Neurology, University at BuffaloBuffaloNew York14203
Ralph HB Benedict, Prof
[email protected]
716-323-0556
Ralph HB Benedict, Prof (PRINCIPAL_INVESTIGATOR)

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By condition
Multiple sclerosis
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NeurologyBrain disordersAutoimmune disease
By research site
Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo· Buffalo, NY

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