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Mindfulness During COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319445
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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

Condition or disease Intervention/treatment Phase
Migraine Disorders Stress Anxiety Behavioral: Mindfulness session(s) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mindfulness During COVID-19 - Remote Mindfulness Sessions
Actual Study Start Date : March 22, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Helpfulness of the session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
    Total scale 1-5. Higher scores denotes better outcomes.

  2. Platform effectiveness [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
    Total scale 1-5. Higher scores denotes better outcomes.


Secondary Outcome Measures :
  1. Change in Anxiety Level [ Time Frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) ]
    Total scale 1-5. Higher scores denotes worse outcomes.

  2. Change in Stress Level [ Time Frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) ]
    Total scale 1-5. Higher scores denotes worse outcomes.

  3. Value of the session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
    Total scale 1-5. Higher scores denotes better outcomes.

  4. Satisfaction with the session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
    Total scale 1-5. Higher scores denotes better outcomes.

  5. Percentage of participants that showed interest in a future session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
  6. Percentage of participants that would recommend this session to a family member [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
  7. Percentage of participants by session frequency preference [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
    Percentage of participants that would prefer to participate in daily, weekly or monthly similar sessions again if offered


Other Outcome Measures:
  1. Concern level about the COVID 19 pandemic [ Time Frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) ]
    Total scale 1-5. Higher scores denotes worse outcomes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319445


Contacts
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Contact: Rebecca E Wells, MD, MPH 336-716-2357 WFBH_Mindfulness@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Rebecca Wells, MD       WFBH_Mindfulness@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Rebecca E Wells, MD, MPH Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04319445    
Other Study ID Numbers: IRB00064587
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
COVID-19
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases