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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversiteit Leiden

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Conscientiousness CoachingExperimental treatment 1 intervention
Group B: Sham InterventionSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Between baseline and week 18.
2

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.

Time frame
Between baseline and week 18.

Secondary outcomes

1

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.

Time frame
Between baseline and week 18.
2

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.

Time frame
Between baseline and week 18.
3

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.

Time frame
Between baseline and week 18.
4

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.

Time frame
Between baseline and week 18.

Other outcomes

1

Effect of personality

The effect of baseline trait conscientiousness, neuroticism and personality measured with the Big Five Inventory 2 on all outcomes.

Time frame
Between baseline and week 18.
2

Effect of demographics

The effect of baseline demographic variables, namely age, sex, nationality, and education will be studied on the described outcomes.

Time frame
Between baseline and week 18.
3

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.

Time frame
Between baseline and week 12.
4

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.

Time frame
At week 18.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiteit Leiden

Lead sponsor

Reha Rheinfelden

Collaborator

University at Buffalo

Collaborator