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

NCT07225868 | Recruiting

• 2 other identifiers: NL86331.058.24OZ2023-017
• Study Type: interventional
• Target: 126
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Multiple Sclerosis

Keywords

Multiple Sclerosis; Conscientiousness; Cognitive Rehabilitation; Brain Imaging; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Objective cognitive changes between baseline and post-intervention

  Objective cognitive changes between baseline and post intervention will be assessed using the Symbol Digit Modalities Test assessing information processing speed.

  Between baseline and week 18.

• Subjective cognitive changes between baseline and post-intervention

  Subjective cognitive changes between baseline and post intervention will be assessed using the Multiple Sclerosis Instrumental Activities of Daily Living Questionnaire.

  Between baseline and week 18.

Secondary Outcomes (12)

• Changes between baseline and week 18 on meaning of life in the intervention compared to the sham intervention group.

  Between baseline and week 18.

• Changes between baseline and week 18 on fatigue in the intervention compared to the sham intervention group.

  Between baseline and week 18.

• Changes between baseline and week 18 on quality of life in the intervention compared to the sham intervention group.

  Between baseline and week 18.

• Changes between baseline and week 18 on psychological outcomes in the intervention compared to the sham intervention group.

  Between baseline and week 18.

• Changes between week 12 and week 18 on goal attainment in the intervention compared to the sham intervention group.

  Between week 12 and week 18.

Other Outcomes (4)

• Effect of personality

  Between baseline and week 18.

• Effect of demographics

  Between baseline and week 18.

• Effect of C-Coach

  Between baseline and week 12.

Study Arms (2)

Conscientiousness Coaching

EXPERIMENTAL

Behavioral: Conscientiousness Coaching Before Cognitive Rehabilitation

Sham Intervention

SHAM COMPARATOR

Behavioral: Sham Intervention Before Cognitive Rehabilitation

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).

Conscientiousness Coaching

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).

Sham Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age 18-65 years
• Language Dutch, English or German for each centre respectively

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Leiden: lead
• Reha Rheinfelden: collaborator
• University at Buffalo: collaborator

Study Sites (3)

Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo

Buffalo, New York, 14203, United States

NOT YET RECRUITING

Health, Medical and Neuropsychology, Institute of Psychology, Faculty of Behvavioural and Social Siences, Leiden University

Leiden, 2333AK, Netherlands

RECRUITING

Research Department, Reha Rheinfelden

Rheinfelden, 4310, Switzerland

NOT YET RECRUITING

Related Links

• Information about study and recruitment

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hanneke E Hulst, Prof

  Leiden University

  PRINCIPAL INVESTIGATOR

• Priska Zuber, PhD

  Reha Rheinfelden

  PRINCIPAL INVESTIGATOR

• Ralph HB Benedict, Prof

  Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo

  PRINCIPAL INVESTIGATOR

• Marit FL Ruitenberg, PhD

  Leiden University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte C Rouzee, MSc

CONTACT

062 831 93 32; c.c.rouzee@fsw.leidenuniv.nl

Marit FL Ruitenberg, PhD

CONTACT

071 527 2727; m.f.l.ruitenberg@fsw.leidenuniv.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 10, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); US (1); NL (1)