Mindfulness During COVID-19

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04319445
Collaborator
(none)
144
1
1
4.2
34.5

Study Details

Study Description

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
  • Behavioral: Mindfulness session(s)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
144 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 :
Mar 23, 2020
Actual Primary Completion Date :
Jul 28, 2020
Actual Study Completion Date :
Jul 28, 2020

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Helpfulness of the Session [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?"

  2. Platform Effectiveness [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?"

Secondary Outcome Measures

  1. Change in Anxiety Level [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?"

  2. Change in Stress Level [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?"

  3. Value of the Session [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?"

  4. Satisfaction With the Session [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?"

  5. Percentage of Participants That Showed Interest in a Future Session [Post-Intervention (upon completion of session up to 15 minutes)]

    Percentage of participants that showed interest in a future session

  6. 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 that would recommend this session to a family member

  7. Percentage of Participants by Session Frequency Preference - Daily [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

  8. Percentage of Participants by Session Frequency Preference - Weekly [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

  9. Percentage of Participants by Session Frequency Preference - Monthly [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

Other Outcome Measures

  1. Decreased Concern Level About the COVID 19 Pandemic [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?"

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest Health Sciences Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Rebecca E Wells, MD, MPH, Wake Forest University Health Sciences

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT04319445
Other Study ID Numbers:
  • IRB00064587
First Posted:
Mar 24, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Period Title: Overall Study
STARTED 144
COMPLETED 144
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Overall Participants 144
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
48.6
(15.6)
Sex: Female, Male (Count of Participants)
Female
117
81.3%
Male
27
18.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
4
2.8%
Asian
16
11.1%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
11
7.6%
White
108
75%
More than one race
0
0%
Unknown or Not Reported
5
3.5%
Region of Enrollment (participants) [Number]
United States
144
100%

Outcome Measures

1. Primary Outcome
Title Helpfulness of the Session
Description 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?"
Time Frame Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Number [percentage of participants]
89
61.8%
2. Primary Outcome
Title Platform Effectiveness
Description 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?"
Time Frame Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Number [percentage of participants]
89
61.8%
3. Secondary Outcome
Title Change in Anxiety Level
Description 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?"
Time Frame Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Number [percentage of participants]
76
52.8%
4. Secondary Outcome
Title Change in Stress Level
Description 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?"
Time Frame Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Number [percentage of participants]
80
55.6%
5. Secondary Outcome
Title Value of the Session
Description 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?"
Time Frame Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Number [percentage of participants]
87
60.4%
6. Secondary Outcome
Title Satisfaction With the Session
Description 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?"
Time Frame Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Number [percentage of participants]
92
63.9%
7. Secondary Outcome
Title Percentage of Participants That Showed Interest in a Future Session
Description Percentage of participants that showed interest in a future session
Time Frame Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Count of Participants [Participants]
131
91%
8. Secondary Outcome
Title Percentage of Participants That Would Recommend This Session to a Family Member
Description Percentage of participants that would recommend this session to a family member
Time Frame Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Count of Participants [Participants]
137
95.1%
9. Secondary Outcome
Title Percentage of Participants by Session Frequency Preference - Daily
Description Percentage of participants that would prefer to participate in daily similar sessions again if offered
Time Frame Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Count of Participants [Participants]
51
35.4%
10. Other Pre-specified Outcome
Title Decreased Concern Level About the COVID 19 Pandemic
Description 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?"
Time Frame Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Count of Participants [Participants]
79
54.9%
11. Secondary Outcome
Title Percentage of Participants by Session Frequency Preference - Weekly
Description Percentage of participants that would prefer to participate in weekly similar sessions again if offered
Time Frame Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Count of Participants [Participants]
69
47.9%
12. Secondary Outcome
Title Percentage of Participants by Session Frequency Preference - Monthly
Description Percentage of participants that would prefer to participate in monthly similar sessions again if offered
Time Frame Post-Intervention (upon completion of session up to 15 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Measure Participants 144
Count of Participants [Participants]
24
16.7%

Adverse Events

Time Frame 15 minutes
Adverse Event Reporting Description
Arm/Group Title Migraine Patients/Providers/Faculty/Staff/Other
Arm/Group Description Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
All Cause Mortality
Migraine Patients/Providers/Faculty/Staff/Other
Affected / at Risk (%) # Events
Total 0/144 (0%)
Serious Adverse Events
Migraine Patients/Providers/Faculty/Staff/Other
Affected / at Risk (%) # Events
Total 0/144 (0%)
Other (Not Including Serious) Adverse Events
Migraine Patients/Providers/Faculty/Staff/Other
Affected / at Risk (%) # Events
Total 0/144 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Rebecca E Wells, MD, MPH
Organization Wake Forest University Health Sciences
Phone 336-716-2357
Email rewells@wakehealth.edu
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT04319445
Other Study ID Numbers:
  • IRB00064587
First Posted:
Mar 24, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Mar 1, 2021