COVID-19 Clinical Trial
Official title:
The Benefit of Mindfulness-Based Intervention Using A Wearable Wellness Brain Sensing Device (Muse-S™) in the Treatment of Post-Covid Symptoms
Verified date | December 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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