Coaching goal-directed behaviour to improve cognitive rehabilitation for people with MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• Health, Medical and Neuropsychology, Institute of Psychology, Faculty of Behvavioural and Social Siences, Leiden University
  Leiden, Netherlands Recruiting
• Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo
  Buffalo, New York, United States Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treadmill-based virtual reality walking training for MS patients

  This study tests whether a treadmill with virtual reality and smart socks can help people with multiple sclerosis walk better and feel safer in daily life.

  Recruiting Shepherd Center, Atlanta GA · Atlanta, Georgia · NCT07927439

• Virtual Reality and Mental Practice to Improve Balance and Walking in Relapsing MS

  This study tests whether virtual reality training or mental practice can improve balance and walking in people with relapsing–remitting multiple sclerosis.

  Recruiting Cairo University · Giza, Giza Governorate · NCT07918339

• REAL-MS: A Look at Autologous Stem Cell Transplant vs High-Efficacy MS Therapies in Real-World Care

  This study tests how AHSCT compares to high-efficacy MS medicines in adults treated in routine clinical care.

  Recruiting Imperial College London · London and 2 other locations · NCT07899502

• Tolebrutinib in real-world MS care for patients treated by clinicians

  This real-world study sees how tolebrutinib is used for multiple sclerosis patients and what outcomes look like in everyday practice.

  Recruiting Sanofi · Marina, Abu Dhabi Emirate · NCT07898371

• Pilates via live video vs. prerecorded videos for people with multiple sclerosis

  This study tests whether live, coach-led Pilates sessions through video calls are more beneficial than prerecorded Pilates videos for adults with MS.

  Recruiting Yuzuncu Yil University · Van · NCT07893925

• Cooling During Inpatient Rehab for People with MS

  This trial tests whether wearing a cooling vest during intensive training can reduce fatigue and improve walking, strength, balance, and cognition in people with multiple sclerosis during a 3-week inpatient rehab stay.

  Recruiting Klinik Valens · Valens, Canton of St. Gallen · NCT07852156

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.