Coaching goal-directed behaviour to improve cognitive rehabilitation for people with MS
Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS?
It will test whether 12 weeks of conscientiousness coaching before six weeks of cognitive rehabilitation helps adults with multiple sclerosis improve thinking skills and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universiteit Leiden Academic / other |
| Locations | 3 sites (Buffalo, New York and 2 other locations) |
| Trial ID | NCT07225868 on ClinicalTrials.gov |
What this trial studies
This multicentre, parallel-group trial will randomize 126 adults with relapsing-remitting or secondary progressive MS to receive either a 12-week conscientiousness coaching program or a sham training, followed by six weeks of the same cognitive rehabilitation for both groups. Outcomes include behavioral measures of cognition and well-being across three assessment sessions, with a brain-imaging subsample undergoing fMRI to track neural change. The intervention targets personality-driven, goal-directed behaviour to see if enhancing conscientiousness increases engagement with and benefit from cognitive training. Sites are in the Netherlands, the United States, and Switzerland and testing is done in the local language (Dutch, English, or German).
Who should consider this trial
Good fit: Adults 18–65 with relapsing-remitting or secondary progressive MS, EDSS under 7, relapse-free for at least 3 months, on stable disease-modifying therapy for ≥2 months, and able to complete assessments in the site's language are ideal candidates.
Not a fit: People with very high baseline conscientiousness, recent relapse or unstable treatment, other neurological or severe psychiatric conditions, substance use affecting cognition, or who cannot attend the participating sites or speak the required language may not benefit or be eligible.
Why it matters
Potential benefit: If successful, adding conscientiousness coaching could increase the effectiveness of cognitive rehabilitation and improve daily functioning and quality of life for people with MS.
How similar studies have performed: Previous cognitive rehabilitation studies have shown mild-to-moderate group benefits and early work indicates conscientiousness can be increased and linked to better outcomes, but using conscientiousness coaching before cognitive rehab is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Buffalo, New York and 2 other locations
- Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo — Buffalo, New York, United States (Not_yet_recruiting)
- Health, Medical and Neuropsychology, Institute of Psychology, Faculty of Behvavioural and Social Siences, Leiden University — Leiden, Netherlands (Recruiting)
- Research Department, Reha Rheinfelden — Rheinfelden, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Hanneke E Hulst, Prof — Leiden University
- Study coordinator: Charlotte C Rouzee, MSc
- Email: c.c.rouzee@fsw.leidenuniv.nl
- Phone: 062 831 93 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.