Mindfulness Intervention for Post-Covid Symptoms

Not Applicable

Active, not recruiting

• Conditions: COVID-19; Post Acute Sequelae of SARS-CoV-2
• Interventions: Device: Muse S™ Headband system

• Registration Number: NCT05199233
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

This study will answer the following question: does meditation help decrease stress and anxiety in patients who are experiencing long-haulers syndrome.

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-20
• Study Start: 2022-06-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Muse S™ Headband system for post-Covid Syndrome	Muse S™ Headband system	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).

Primary Outcome Measures

Name	Time	Method
Reducing Stress	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.
Reducing Anxiety	3 months post-baseline	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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States