Mindfulness Intervention for Post-Covid Symptoms

NCT05199233 | Completed Results FDA Device

• 1 other identifier: 21-009820
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Post Acute Sequelae of SARS-CoV-2

Keywords

Covid-19; PASC; Pandemic; Meditation

Outcome Measures

Primary Outcomes (2)

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

  3 months post-baseline

• Change in Anxiety

  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.

  3 months post-baseline

Study Arms (1)

Muse S™ Headband system for post-Covid Syndrome

EXPERIMENTAL

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

Interventions

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).

Muse S™ Headband system for post-Covid Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Hurt RT, Ganesh R, Schroeder DR, Hanson JL, Fokken SC, Overgaard JD, Bauer BA, Thilagar BP, Aakre CA, Pruthi S, Croghan IT. Using a Wearable Brain Activity Sensing Device in the Treatment of Long COVID Symptoms in an Open-Label Clinical Trial. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251325639. doi: 10.1177/21501319251325639. Epub 2025 Mar 12.

  PMID: 40071827 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Ivana T. Croghan
• Organization: Mayo Clinic Rochester

gimresearchstudies@mayo.edu

507 284-2511

Study Officials

• Ivana Croghan, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Ryan Hurt, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All subjects will receive and use the Muse S™ Headband system

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 20, 2022
• Study Start: June 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-03

Locations

US (1)