Mindfulness Intervention for Post-COVID Syndrome

Overseen By Gillian Currie, MBA, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Investigational drugs

Disqualifiers: Unstable health, Mindfulness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Muse S™ Headband, a brain-sensing wellness device, can reduce stress and anxiety in individuals with Post-COVID Syndrome. Participants will use the device at least four times a week for 10 minutes per session over three months. It suits those diagnosed with Post-COVID Syndrome at Mayo Clinic Rochester who have regular access to a smartphone or tablet and are not currently practicing mindfulness or enrolled in stress-related programs.

As an unphased trial, it provides a unique opportunity to explore innovative stress-reduction methods.

Will I have to stop taking my current medications?

The trial requires that participants be on a stable dose of medication for anxiety, depression, or sleep. If your medication is not stable, you may need to adjust it before joining the trial.

What prior data suggests that the Muse S™ Headband system is safe for reducing stress and anxiety in post-COVID syndrome?

Research has shown that the Muse S™ Headband is generally safe and well-tolerated. In studies where participants used the headband regularly, no major safety issues emerged. The device, worn on the head, senses brain activity and aids in meditation.

Users experienced no serious side effects. It is important to note that the device was safely used by individuals without health conditions that could affect its use. This suggests that for most people, the Muse S™ Headband is a safe option for managing stress and anxiety after COVID. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for post-COVID syndrome, which often include medications to manage symptoms, the Muse S™ Headband system uses a unique method that focuses on mindfulness and biofeedback. This device guides users through meditation sessions by monitoring brain activity and providing real-time feedback, which can help reduce stress and promote mental clarity. Researchers are excited about this approach because it is non-invasive, easy to use, and empowers patients to actively participate in their recovery process by improving mental well-being, potentially leading to broader physical health benefits.

What evidence suggests that the Muse S™ Headband system is effective for reducing stress and anxiety in Post-COVID Syndrome?

Research has shown that the Muse S™ Headband system, which participants in this trial will use, might help reduce symptoms related to post-COVID syndrome, such as stress and anxiety. In a 180-day study, participants using the Muse S experienced noticeable improvements in these symptoms. The headband employs neurofeedback, a method that trains the brain to handle stress better. Another study found that devices like the Muse S, used for neuro-meditation, can help with cognitive issues and mental fatigue. This suggests that the Muse S headband could be a useful tool for managing stress and anxiety after COVID. ^{1 3 6 7 8}

Who Is on the Research Team?

Ivana Croghan, PhD

Principal Investigator

Mayo Clinic

Ryan Hurt, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who have had COVID-19 and are now experiencing long-term symptoms. Participants must not be pregnant, should have access to a smartphone or tablet, and be able to fully participate in the study. They should not have any health conditions that would affect using the Muse S™ headband and not be on unstable medication doses.

Inclusion Criteria

I have been diagnosed with a specific type of long COVID at Mayo Clinic Rochester.

Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-SÔ system, as determined by the clinical investigators.

Have the ability to provide informed consent.

Exclusion Criteria

Currently (within 3 weeks) has been enrolled in another clinical or research program which intervenes on the patients' QOL, or stress.

An unstable medical or mental health condition as determined by the physician investigator.

I have been practicing mindfulness regularly for the past 3 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants utilize the Muse S™ Headband system at least 4 times per week for a minimum of 10 minutes each time over a period of 3 months

12 weeks

Follow-up

Participants are monitored for changes in stress and anxiety after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Muse S™ Headband system

Trial Overview The trial is testing whether a wearable brain sensing device called Muse S™ can help reduce stress and anxiety in people with lingering post-Covid symptoms by teaching them meditation practices.

How Is the Trial Designed?

Group I: Muse S™ Headband system for post-Covid Syndrome Experimental Treatment 1 Intervention

Subjects will utilize the Muse S™ Headband system at least 4 times per week for a minimum of 10 minutes each time over a period of 3 months (12 weeks).

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A systematic review of six randomized controlled trials (RCTs) found that online-based mindfulness programs can effectively reduce psychological issues like anxiety, depression, and stress during the COVID-19 pandemic.

These mindfulness interventions are suggested as complementary treatments for various groups, including clinical populations, healthy individuals, and healthcare workers facing psychological challenges due to the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological Effects of Online-Based Mindfulness Programs during the COVID-19 Pandemic: A Systematic Review of Randomized Controlled Trials. Yeun, YR., Kim, SD.[2022]

Mindfulness practitioners experienced significantly lower levels of pandemic-related distress, depression, anxiety, and stress compared to non-practitioners during the COVID-19 outbreak, based on assessments from 673 mindfulness practitioners and 1550 non-practitioners.

Increased frequency of mindfulness practice was linked to greater improvements in mental health, suggesting that mindfulness meditation could serve as an effective and low-cost intervention to alleviate psychological distress during pandemics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness practice for protecting mental health during the COVID-19 pandemic. Zhu, JL., Schülke, R., Vatansever, D., et al.[2021]

A community-based Long Covid support service combining psycho-educational and mind-body approaches showed positive outcomes, with participants reporting improvements in mental, physical, emotional, and spiritual wellbeing as measured by the Warwick Holistic Health Questionnaire.

Out of 25 participants, 16 showed significant improvement in their wellbeing scores after engaging with the service, indicating that this complementary approach is beneficial for individuals experiencing health challenges from Long Covid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A service evaluation of a community project combining psychoeducation and mind-body complementary approaches to support those with long covid in the UK. Brough, DN., Abel, S., Priddle, L.[2023]

Citations

1. choosemuse.com choosemuse.com/blogs/news/can-muse-s-help-long-covid-symptoms-a-180-day-study-reveals-the-data?srsltid=AfmBOop5G3toZ2afa2Sa6h4ghWfknretuye6ryZf-I0Ud-Ju5ruTc4yC

Can Muse S help long COVID symptoms? A 180-day study ... In short: The results showed measurable improvements across key symptoms. Could this simple, at-home neurofeedback practice support recovery ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11905036/

Using a Wearable Brain Activity Sensing Device in the ... Muse-S™ is a wearable brain S-EEG device which is a clinical-grade, headband-style wireless EEG system with 7 sensor and 4 channels of EEG data.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/33/NCT05199233/Prot_SAP_000.pdf

The Benefit of Mindfulness-Based Intervention Using A ... Primary Hypothesis: a) Post Covid patients enrolled in this study will find the Muse-S™ Headband system easy to use and will use it per protocol ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9858974/

Positive Impacts of a Four-Week Neuro-Meditation Program ... Initial evidence suggests that neuro-meditation reduces cognitive impairment and improves physical and mental fatigue, muscle and joint pain, symptoms of ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/21501319251325639

Using a Wearable Brain Activity Sensing Device in the ... This study evaluated the feasibility and satisfaction of using a wearable brain activity sensing device for stress reduction among patients experiencing Long ...

6. choosemuse.com choosemuse.com/blogs/news/can-muse-s-help-long-covid-symptoms-a-180-day-study-reveals-the-data?srsltid=AfmBOoqTvimJ_Tc9npgnvYXgEDSOJLBsbVlMXmaQjnzLfQ_Rs8hX04i8

Can Muse S help long COVID symptoms? A 180-day study ... Researchers tested whether the Muse S headband, combined with daily meditation, could help ease symptoms of long COVID.

7. mayo.edu mayo.edu/research/clinical-trials/cls-20582690

EEG sensing headband for improving long Covid sleep ... Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S™ system, as determined by the clinical investigators.

8. withpower.com withpower.com/trial/phase-covid-19-1-2022-f4154

Mindfulness Intervention for Post-COVID Syndrome This trial studies if using the Muse-S headband to practice meditation can help post-Covid patients with long-term symptoms feel less stressed and anxious. Show ...