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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

3 months post-baseline

Results posted on

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

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).
Overall Study
STARTED
45
Overall Study
COMPLETED
44
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

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).
Overall Study
Lack of Efficacy
1

Baseline Characteristics

Mindfulness Intervention for Post-Covid Symptoms

Baseline characteristics by cohort

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).
Age, Continuous
47.6 years
STANDARD_DEVIATION 12.5 • n=99 Participants
Sex: Female, Male
Female
37 Participants
n=99 Participants
Sex: Female, Male
Male
8 Participants
n=99 Participants
Race/Ethnicity, Customized
race/ethnicity · White, Non-Hispanic
43 Participants
n=99 Participants
Race/Ethnicity, Customized
race/ethnicity · other
2 Participants
n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

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).
Change in Stress
-5.0 units on a scale
Standard Deviation 5.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

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).
Change in Anxiety
-4.5 units on a scale
Standard Deviation 5.5

Adverse Events

Muse S™ Headband System for Post-Covid Syndrome

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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).
Nervous system disorders
migraine headache
2.2%
1/45 • Number of events 1 • 90 days

Additional Information

Dr. Ivana T. Croghan

Mayo Clinic Rochester

Phone: 507 284-2511

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place