About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Conscientiousness Coaching Before Cognitive Rehabilitation
BehavioralIn 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
BehavioralIn 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).
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Changes between baseline and week 18 on meaning of life in the intervention compared to the sham intervention group.
Changes on the Meaning of Life Questionnaire comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Changes between baseline and week 18 on fatigue in the intervention compared to the sham intervention group.
Changes on the Checklist of Individual Strength comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Changes between baseline and week 18 on quality of life in the intervention compared to the sham intervention group.
Changes on the 36-Item Short Form Survey comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Changes between baseline and week 18 on psychological outcomes in the intervention compared to the sham intervention group.
Changes on the Hospital Anxiety and Depression Scale comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Other outcomes
Effect of personality
The effect of baseline trait conscientiousness, neuroticism and personality measured with the Big Five Inventory 2 on all outcomes.
Effect of demographics
The effect of baseline demographic variables, namely age, sex, nationality, and education will be studied on the described outcomes.
Effect of C-Coach
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.
Feedback on C-Coach or sham intervention
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.
Sponsors and contacts
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