Mindset Training for MS

Recruiting at 2 trial locations

Overseen By Charlotte C Rouzee, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Universiteit Leiden

Disqualifiers: High conscientiousness, Brain trauma, Psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with Multiple Sclerosis (MS) improve cognitive skills such as memory and focus, which often present challenges for those living with the condition. The study uses a personalized app-based training program to enhance brain function and overall quality of life. Participants will first engage in mindset training with a coach (Conscientiousness Coaching), followed by exercises to boost memory and processing speed. Suitable candidates include those with a confirmed diagnosis of relapsing-remitting or secondary progressive MS who have been stable in their condition and treatment for a few months. As an unphased trial, this study provides a unique opportunity to explore innovative methods to improve cognitive function and quality of life for MS patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it excludes those whose medication affects cognitive functioning. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Conscientiousness Coaching, a smartphone-based program, is safe for people with multiple sclerosis (MS). Studies involving MS patients and older healthy adults have examined this type of coaching. These studies found it easy to handle, with no major side effects reported. The coaching aims to boost conscientiousness, which is linked to better management of chronic conditions like MS. Overall, evidence suggests that this coaching method safely helps improve thinking skills in people with MS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindset Training for MS trial because it explores a novel approach to managing multiple sclerosis (MS) through behavioral modifications rather than traditional medication. Unlike most MS treatments that focus on slowing disease progression with drugs like interferons or monoclonal antibodies, Conscientiousness Coaching aims to enhance patients' mental resilience and self-discipline. This could potentially empower individuals to better manage their symptoms and improve their quality of life. Additionally, the trial includes a Sham Intervention to effectively measure the true impact of the coaching, ensuring that any positive outcomes are directly attributed to the mindset training.

What evidence suggests that this trial's treatments could be effective for improving cognitive functioning in people with MS?

Research has shown that conscientiousness, characterized by being careful and diligent, can lead to better outcomes for individuals with neurological conditions like multiple sclerosis (MS). In this trial, participants may receive Conscientiousness Coaching through a smartphone app designed to enhance conscientiousness in people with MS, potentially aiding the brain in developing new problem-solving strategies. One study found that using an app to boost conscientiousness improved work performance over three months in individuals at risk. These findings suggest that coaching to increase conscientiousness, especially through digital tools, could enhance thinking skills and quality of life for those with MS. ^{1 3 4 6 7}

Who Is on the Research Team?

Hanneke E Hulst, Prof

Principal Investigator

Leiden University

Priska Zuber, PhD

Principal Investigator

Reha Rheinfelden

Ralph HB Benedict, Prof

Principal Investigator

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

Marit FL Ruitenberg, PhD

Principal Investigator

Leiden University

Are You a Good Fit for This Trial?

This trial is for people with Multiple Sclerosis who experience cognitive issues. Participants should be willing to undergo app-based training and fMRI scans. Specific eligibility criteria are not provided, but typically include being diagnosed with MS and meeting certain health conditions.

Inclusion Criteria

Language Dutch, English or German for each centre respectively

I am between 18 and 65 years old.

My disability score is less than 7, meaning I can walk.

Exclusion Criteria

Psychiatric disorder that heavily impacts cognitive and/or daily functioning

High conscientiousness, measured with a T score 65 or higher on the BFI-2 subscale for conscientiousness

Medication intake and/or substance abuse that has an influence on cognitive functioning

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conscientiousness Coaching or Sham Intervention

Participants undergo 12 weeks of either C-Coach or sham intervention, including pre-session and booster sessions with a coach, and self-use of a smartphone application.

12 weeks

3 visits (in-person or virtual)

Cognitive Rehabilitation

Participants perform two 60-minute training sessions per week using the CR training application BrainHQ.

6 weeks

12 sessions (self-administered)

Follow-up

Participants are monitored for cognitive changes and other outcomes using questionnaires and fMRI.

4 weeks

1 visit (in-person for fMRI)

What Are the Treatments Tested in This Trial?

Interventions

• Conscientiousness Coaching
• Sham Intervention

Trial Overview The study tests if coaching on goal-directed behavior before cognitive rehabilitation can improve outcomes in MS patients. It compares conscientiousness coaching followed by memory and concentration training against a sham intervention plus the same cognitive exercises.

How Is the Trial Designed?

Group I: Conscientiousness Coaching Experimental Treatment 1 Intervention

Group II: Sham Intervention Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Universiteit Leiden

Lead Sponsor

Trials

19

Recruited

2,700+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

Reha Rheinfelden

Collaborator

Trials

11

Recruited

420+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12356716/

insights from multiple sclerosis and healthy aging samples This study evaluated a smartphone-based intervention to enhance Conscientiousness in people with multiple sclerosis (PwMS) and healthy aging (HA) ...

2. buffalo.edu buffalo.edu/ubnow/stories/2022/10/benedict-conscientiousness-app.html

App may help MS patients fight cognitive decline “Research suggests that a high level of conscientiousness is predictive of better outcomes in neurological illness, and as such may be linked to ...

3. ijmsc.org ijmsc.org/view/preliminary-support-of-a-behavioral-intervention-for-trait-conscientiousness-in-multiple-sclerosis

Preliminary Support of a Behavioral Intervention for Trait ... A newly developed application-facilitated intervention for low conscientiousness improved work outcomes over 3 months in at-risk individuals ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40817184/

insights from multiple sclerosis and healthy aging samples This study evaluated a smartphone-based intervention to enhance Conscientiousness in people with multiple sclerosis (PwMS) and healthy aging (HA) ...

5. buffalo.edu buffalo.edu/news/releases/2022/10/010.html

For MS patients, an app to boost conscientiousness may ... UB pilot study on the app is based on preliminary findings that conscientiousness improves patients' cognitive reserve and might even help them stay employed.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034825003013

Personality traits and disease worsening in multiple sclerosis High Conscientiousness was significantly associated with a decreased hazard of course change (HR = 0.97 per T score point of Conscientiousness, 95 % CI [0.95 to ...

7. neurologylive.com neurologylive.com/view/reviewing-power-health-wellness-coaching-ms-care

Reviewing the Power of Health and Wellness Coaching in ... Health coaching could be an effective patient education method for the management of chronic diseases such as multiple sclerosis (MS).