Mindfulness During COVID-19

February 24, 2022 updated by: Wake Forest University Health Sciences

Mindfulness During COVID-19 - Remote Mindfulness Sessions

The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic.The investigators are interested in targeting patients with migraine, providers, faculty and staff. The investigators are hopeful that this will positively impact overall well-being at this stressful time. The investigators are interested in assessing feasibility, accessibility, and overall interest of an online mindfulness intervention in these populations at this time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any person interested in participating in the mindfulness session will be eligible to complete the pre/post surveys and participate in the mindfulness session.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Migraine Patients/Providers/Faculty/Staff/Other
Behavioral: Mindfulness session(s)
The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Helpfulness of the Session
Time Frame: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants who Felt the Mindfulness Session was Helpful - After the mindfulness session, participants used a Likert scale rating to respond to the question "How helpful was this session for you?"
Post-Intervention (upon completion of session up to 15 minutes)
Platform Effectiveness
Time Frame: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants who Perceived the Electronic Platform to be Effective for Practicing Mindfulness - After the mindfulness session, participants used a Likert scale rating to respond to the question "Did you find this electronic platform effective for practicing mindfulness?"
Post-Intervention (upon completion of session up to 15 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Anxiety Level
Time Frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants With Reduction in Anxiety After Mindfulness Session - Before and after the mindfulness session, participants responded to the question, "At this moment, how anxious do you feel?"
Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
Change in Stress Level
Time Frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants With Reduction in Stress After Mindfulness Session - Before and after the mindfulness session, participants responded to the question, "At this moment, how much stress do you feel?"
Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
Value of the Session
Time Frame: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants who Felt the Mindfulness Session was Valuable - After the mindfulness session, participants used a Likert scale rating to respond to the question "How much was the session of value to you?"
Post-Intervention (upon completion of session up to 15 minutes)
Satisfaction With the Session
Time Frame: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants who were Satisfied with the Mindfulness Session - After the mindfulness session, participants used a Likert scale rating to respond to the question "How satisfied are you with this experience?"
Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants That Showed Interest in a Future Session
Time Frame: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of participants that showed interest in a future session
Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants That Would Recommend This Session to a Family Member
Time Frame: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of participants that would recommend this session to a family member
Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants by Session Frequency Preference - Daily
Time Frame: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of participants that would prefer to participate in daily similar sessions again if offered
Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants by Session Frequency Preference - Weekly
Time Frame: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of participants that would prefer to participate in weekly similar sessions again if offered
Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants by Session Frequency Preference - Monthly
Time Frame: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of participants that would prefer to participate in monthly similar sessions again if offered
Post-Intervention (upon completion of session up to 15 minutes)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Decreased Concern Level About the COVID 19 Pandemic
Time Frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
Percent of Participants With Reduction in Concern over COVID-19 After Mindfulness Session - Before and after the mindfulness session, participants responded to the question, "At this moment, how concerned are you about the Coronavirus pandemic?"
Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00064587

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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