Trial Outcomes & Findings for Mindfulness Intervention for Post-Covid Symptoms (NCT NCT05199233)
NCT ID: NCT05199233
Last Updated: 2025-04-09
Results Overview
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.
COMPLETED
NA
45 participants
3 months post-baseline
2025-04-09
Participant Flow
Patients with Post-Covid Syndrome were recruited from the Long Covid Clinic at the Mayo Clinic Rochester Site.
Participant milestones
| Measure |
Muse S™ Headband System for Post-Covid Syndrome
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).
Muse S™ Headband system: 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).
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|---|---|
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Overall Study
STARTED
|
45
|
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Overall Study
COMPLETED
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44
|
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Muse S™ Headband System for Post-Covid Syndrome
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).
Muse S™ Headband system: 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).
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|---|---|
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Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Mindfulness Intervention for Post-Covid Symptoms
Baseline characteristics by cohort
| Measure |
Muse S™ Headband System for Post-Covid Syndrome
n=45 Participants
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).
Muse S™ Headband system: 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).
|
|---|---|
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Age, Continuous
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47.6 years
STANDARD_DEVIATION 12.5 • n=99 Participants
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|
Sex: Female, Male
Female
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37 Participants
n=99 Participants
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Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
race/ethnicity · White, Non-Hispanic
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43 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
race/ethnicity · other
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 months post-baselineStress 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.
Outcome measures
| Measure |
Muse S™ Headband System for Post-Covid Syndrome
n=45 Participants
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).
Muse S™ Headband system: 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).
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|---|---|
|
Change in Stress
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-5.0 units on a scale
Standard Deviation 5.3
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PRIMARY outcome
Timeframe: 3 months post-baselinePROMIS 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.
Outcome measures
| Measure |
Muse S™ Headband System for Post-Covid Syndrome
n=45 Participants
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).
Muse S™ Headband system: 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).
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|---|---|
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Change in Anxiety
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-4.5 units on a scale
Standard Deviation 5.5
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Adverse Events
Muse S™ Headband System for Post-Covid Syndrome
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Muse S™ Headband System for Post-Covid Syndrome
n=45 participants at risk
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).
Muse S™ Headband system: 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).
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Nervous system disorders
migraine headache
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2.2%
1/45 • Number of events 1 • 90 days
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place