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Mindfulness Intervention for Post-Covid Symptoms

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Muse S™ Headband system

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Covid-19, PASC, Pandemic, Meditation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Muse S™ Headband system for post-Covid Syndrome

Arm Description

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).

Outcomes

Primary Outcome Measures

Reducing 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.

Reducing Anxiety

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05199233

First Posted

January 18, 2022

Last Updated

June 2, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05199233

Brief Title

Mindfulness Intervention for Post-Covid Symptoms

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Covid-19, PASC, Pandemic, Meditation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Muse S™ Headband system for post-Covid Syndrome

Arm Type

Experimental

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

Muse S™ Headband system

Intervention Description

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 Outcome Measure Information:

Title

Reducing Stress

Description

Time Frame

3 months post-baseline

Title

Reducing Anxiety

Description

Time Frame

3 months post-baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shawn Fokken, CCRP

Phone

507-293-2740

gimresearchstudies@mayo.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Gillian Currie, MBA, CCRP

Phone

507-266-3223

gimresearchstudies@mayo.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ivana Croghan, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ryan Hurt, MD, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shawn Fokken, CCRP

Phone

507-293-2740

gimresearchstudies@mayo.edu

First Name & Middle Initial & Last Name & Degree

Gillian Currie, MBA, CCRP

Phone

507-266-3223

gimresearchstudies@mayo.edu

First Name & Middle Initial & Last Name & Degree

Ivana T Croghan, PhD

First Name & Middle Initial & Last Name & Degree

Ryan T Hurt, MD, PhD

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Mindfulness Intervention for Post-Covid Symptoms

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