Mindfulness Intervention for Post-Covid Symptoms

Study Overview
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Brief Summary
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The purpose of this research is to study if post-Covid patients using a wearable brain sensing wellness device (Muse-S) to learn meditation practice during a time where they are experiencing lengthy Covid symptoms will help in decreasing stress and anxiety.

Detailed Description
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This study will answer the following question: does meditation help decrease stress and anxiety in patients who are experiencing long-haulers syndrome.

Official Title
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The Benefit of Mindfulness-Based Intervention Using A Wearable Wellness Brain Sensing Device (Muse-S&#8482;) in the Treatment of Post-Covid Symptoms

Conditions
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COVID-19, Post Acute Sequelae of SARS-CoV-2

Intervention / Treatment
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* Device: Muse S™ Headband system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identified with one of 3 Post-Covid Syndrome (PASC) phenotypes at Mayo Clinic Rochester. Not pregnant by subject self-report at time of consent. Have the ability to provide informed consent. Have the ability to complete all aspects of this trial. Have access to an iPhone, iPad, or Android device. Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-SÔ system, as determined by the clinical investigators. Exclusion Criteria: Used an investigational drug within the past 30 days. Anyone that is not on a stable dose of medication for anxiety, depression or sleep. Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will receive and use the Muse S™ Headband system
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muse S™ Headband system for post-Covid Syndrome<br>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). | Device: Muse S™ Headband system<br>* Clinical grade, headband style, wireless EEG (electroencephalogram is a test used to evaluate the electrical activity in the brain) system and designed to interact with a mobile device (smartphone or tablet).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing Stress | Stress is evaluated through the Perceived Stress Scale (PSS). This is a 10-item Likert scale that measures global life stress by assessing the degree to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. | 3 months post-baseline | 
| Reducing Anxiety | State-Trait Anxiety Inventory (STAI-Y1) will be used for measure anxiety. This 20 item self-report measure indicates the intensity of feelings of anxiety; it distinguishes between state anxiety (a temporary condition experienced in specific situations) and trait anxiety (a general tendency to perceive situations as threatening). This uses a 4-point visual analog scale and the participant indicates how they feel in the moment (1=not at all to 4=very much so). | 3 months post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, PASC, Pandemic, Meditation