Skip to main content
OpenTrials
Completed

NCT Number: NCT05199233

Mindfulness Intervention for Post-Covid Symptoms

The purpose of this study is to assess the feasibility of using a wearable brain-sensing wellness device (Muse-S) to potentially reduce stress and anxiety during Post-Covid, which is characterized by increased stress and anxiety.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

This study will answer the following questions: 1) will patients experiencing Long-Covid Syndrome utilize a wearable brain-sensing wellness device to potentially reduce stress and anxiety 2) does using this wearable brain-sensing wellness device help decrease stress and anxiety in patients who are experiencing Long-Covid Syndrome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Muse S™ Headband system

Device

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).

Primary outcomes

  1. Change in Stress

    Time frame: 3 months post-baseline

    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. The outcome measure is change in stress from baseline at 3 months (end of treatment). Negative changes indicate decreased stress relative to baseline.

  2. Change in Anxiety

    Time frame: 3 months post-baseline

    PROMIS Emotional Distress-short form 7a (7 items). The PROMIS Anxiety item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. The raw scores were converted to t-scores using published guidelines (see PROMIS website). A T-score of 50 is the average for the general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured; thus, an increase in emotional distress T score corresponds to more anxiety - which is a worse outcome.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Benefit of Mindfulness-Based Intervention Using A Wearable Wellness Brain Sensing Device (Muse-S™) in the Treatment of Post-Covid Symptoms

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2022
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.