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

November 6, 2025 updated by: Marit Ruitenberg, Universiteit Leiden

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale: Cognitive impairment displays a common and impacting symptom in people with multiple sclerosis (PwMS). It has been shown that PwMS benefit from cognitive rehabilitation (CR), but group-effects are mild-to-moderate and effect sizes vary between patients, highlighting the need for including individual factors in investigating CR. It has been shown that PwMS with high conscientiousness, a personality trait that is associated with being well-organised, schema driven, achievement-striving and goal-directed show higher improvement on cognitive functions. Very recent data shows that it is possible to enhance conscientiousness in PwMS and that this increase led to more goal-directed behaviour, decreased depressive symptoms and improvements in QoL.

Objective: To investigate if conscientiousness coaching (C-Coach) before CR will enhance the treatment effects of CR, in which treatment effect is operationalised as improvement from a full comprehensive perspective of well-being of PwMS Study design: This experimental multicentre study in the Netherlands, United States and Switzerland follows a longitudinal, parallel group, controlled design with three assessment sessions including behavioural testing for both study groups and brain imaging in a subsample. Additionally, both groups will undergo either 12-weeks of C-Coach or sham training before six weeks of CR.

Study population: The study population consists of 126 PwMS aged between 18 and 65 years, of which group 1 (N= 63) will undergo C-Coach before CR and group 2 (N= 63) will undergo a sham intervention before CR.

Intervention: All interventions will be performed on mobile devices and can thus be done at home. Group 1 will undergo 12 weeks of C-Coach, which consists of a pre-session and two booster sessions with a coach to explain goals, values and the training application as well as the self-use of the smartphone application C-Coach between sessions to track goals and values. Group 2 will undergo 12 weeks of sham intervention, consisting of a pre-session and two booster sessions with a coach to discuss early life memories and the self-use of the smartphone application Daily Notes to journal about early life memories. Both groups will undergo CR after C-Coach or sham intervention, where they are asked to perform two 60-minutes training sessions per week for the duration of 6 weeks using the CR training application BrainHQ.

Main study parameters/endpoints: Main endpoint will be subjective and objective cognitive changes between baseline and post-intervention on processing speed task and improved cognitive functioning in daily life in PwMS in the intervention group compared to PwMS in the control group. As secondary endpoints, changes between baseline and post-intervention on goal attainment, meaning of life, fatigue, depression, anxiety, cognitive functioning, functional brain networks and social support in PwMS in the intervention group (C-Coach prior to CR) compared to PwMS in the control group (sham intervention prior to CR) will be studied.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of proposed interventions and procedures including MRI scan is negligible, as both can be seen as safe and non-invasive. All participants in the subsample undergoing MRI scans will undergo a detailed screening for MRI contradictions to exclude any risks. The confined space inside the MRI device for the duration of 25 minutes of the scan as well as the time investment of the participant for travel to study location and participation involves some burden for the participants. This study will offer valuable insights in the development of effective cognitive rehabilitation strategies, which will in turn positively impact patients' QoL and their ability to participate in society as they see fit.

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2333AK
        • Recruiting
        • Health, Medical and Neuropsychology, Institute of Psychology, Faculty of Behvavioural and Social Siences, Leiden University
        • Contact:
        • Principal Investigator:
          • Hanneke E Hulst, Prof
        • Principal Investigator:
          • Marit FL Ruitenberg, PhD
        • Sub-Investigator:
          • Charlotte C Rouzee, MSc
  • Switzerland
      • Rheinfelden, Switzerland, 4310
        • Not yet recruiting
        • Research Department, Reha Rheinfelden
        • Contact:
        • Contact:
        • Principal Investigator:
          • Priska Zuber, PhD
        • Principal Investigator:
          • Corina Schuster-Amft, PD PhD
        • Sub-Investigator:
          • Katrin Parmar, Dr. med
  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Not yet recruiting
        • Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo
        • Contact:
        • Principal Investigator:
          • Ralph HB Benedict, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Intervention
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).
Experimental: Conscientiousness Coaching
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between baseline and week 18.
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.
Between baseline and week 18.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes between baseline and week 18 on meaning of life in the intervention compared to the sham intervention group.
Time Frame: Between baseline and week 18.
Changes on the Meaning of Life Questionnaire comparing the intervention (C-Coach prior to CR) group with 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.
Time Frame: Between baseline and week 18.
Changes on the Checklist of Individual Strength comparing the intervention (C-Coach prior to CR) group with 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.
Time Frame: Between baseline and week 18.
Changes on the 36-Item Short Form Survey comparing the intervention (C-Coach prior to CR) group with 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.
Time Frame: Between baseline and week 18.
Changes on the Hospital Anxiety and Depression Scale comparing the intervention (C-Coach prior to CR) group with 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.
Time Frame: Between week 12 and week 18.
Changes on the Goal Attainment Scale comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Between week 12 and week 18.
Changes between baseline and week 18 on multiple sclerosis specific cognitive functioning in the intervention compared to the sham intervention group.
Time Frame: Between baseline and week 18.
Changes on the Brief International Cognitive Assessment for Multiple Sclerosis comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Between baseline and week 18.
Changes between baseline and week 18 on cognitive flexibility in the intervention compared to the sham intervention group.
Time Frame: Between baseline and week 18.
Changes on the Trail Making Test A and B comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Between baseline and week 18.
Changes between baseline and week 18 on verbal fluency in the intervention compared to the sham intervention group.
Time Frame: Between baseline and week 18.
Changes on the Controlled Oral Word Association Test comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Between baseline and week 18.
Changes between baseline and week 18 executive functions in the intervention compared to the sham intervention group.
Time Frame: Between baseline and week 18.
Changes on the Stroop Test comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Between baseline and week 18.
Changes between baseline and week 18 on functional networks in the intervention compared to the sham intervention group.
Time Frame: Between baseline and week 18.
Changes on functional networks measured with resting state functional magnetic resonance imaging comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Between baseline and week 18.
Changes between baseline and week 18 on structural networks in the intervention compared to the sham intervention group.
Time Frame: Between baseline and week 18.
Changes on Structural networks measured with Diffusion Tensor Imaging comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Between baseline and week 18.
Changes between baseline and week 18 on social outcomes in the intervention compared to the sham intervention group.
Time Frame: Between baseline and week 18.
Changes on the Medical Outcomes Study Social Support Survey comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Between baseline and week 18.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of personality
Time Frame: Between baseline and week 18.
The effect of baseline trait conscientiousness, neuroticism and personality measured with the Big Five Inventory 2 on all outcomes.
Between baseline and week 18.
Effect of demographics
Time Frame: Between baseline and week 18.
The effect of baseline demographic variables, namely age, sex, nationality, and education will be studied on the described outcomes.
Between baseline and week 18.
Effect of C-Coach
Time Frame: Between baseline and week 12.
The main and secondary outcomes will be measured at week 12 after C-Coach or sham intervention and before the start of CR in order to replicate previous preliminary findings.
Between baseline and week 12.
Feedback on C-Coach or sham intervention
Time Frame: At week 18.
Participants' responses to a Feedback Questionnaire will be examined at week 18, which includes specific questions about the effectiveness and the experience of the intervention.
At week 18.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Leiden

Collaborators

University at Buffalo
Reha Rheinfelden

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 6, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL86331.058.24
  • OZ2023-017 (Other Grant/Funding Number: Dutch National MS Funds)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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