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

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Muse S™ Headband system for Post-COVID Syndrome?

Research suggests that mindfulness meditation, a component of the Muse S™ Headband system, can help reduce symptoms like fatigue and improve mental health in people with Long COVID. Studies have shown that mindfulness practices can lower depression and anxiety, which are common in post-COVID conditions. ^{1 2 3 4 5}

Is mindfulness intervention safe for humans?

Mindfulness practices, including meditation, have been studied for their mental health benefits and are generally considered safe for humans. They have been shown to reduce anxiety and improve well-being without significant safety concerns. ^{1 2 5 6 7}

How does the Muse S™ Headband system treatment differ from other treatments for post-COVID syndrome?

The Muse S™ Headband system is unique because it uses mindfulness meditation, which has been shown to reduce stress, anxiety, and depression, as a non-drug approach to help manage post-COVID syndrome. Unlike traditional treatments that may focus on medication, this system emphasizes mental health improvement through mindfulness practices, potentially offering a low-cost and accessible option for patients. ^{1 2 5 8 9}

Research Team

Ivana Croghan, PhD

Principal Investigator

Mayo Clinic

Ryan Hurt, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mindfulness practice for protecting mental health during the COVID-19 pandemic. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based online intervention on mental health and quality of life among COVID-19 patients in China: an intervention design. [2021]

3. Netherlands 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. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Mindfulness Meditation Interventions for Long COVID: Biobehavioral Gene Expression and Neuroimmune Functioning. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of an amygdala and insula retraining program combined with mindfulness training to improve the quality of life in patients with long COVID: a randomized controlled trial protocol. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Mindfulness and COVID-19-Related Stress: Staying Present During Uncertain Times. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Daily Mindfulness Meditation App Usage to Reduce Anxiety and Improve Well-Being During the COVID-19 Pandemic: A Randomized Controlled Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Remote delivery of a Koru Mindfulness intervention for college students during the COVID-19 pandemic. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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