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CompletedNCT04319445Updated Mar 2, 2022Results posted

Mindfulness During COVID-19

An interventional study of Mindfulness session(s) in Migraine Disorders, Stress and Anxiety, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Not applicable
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Migraine Disorders
  • Stress
  • Anxiety

Keywords

  • COVID-19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 144 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
144 participants (actual)

Study arms

  • Experimental
    Migraine Patients/Providers/Faculty/Staff/Other

    Behavioral: Mindfulness session(s)

Interventions

  • BehavioralMindfulness session(s)

    The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).

06

What researchers measure

Primary outcomes

  1. Helpfulness of the Session

    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)

  2. Platform Effectiveness

    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)

Secondary outcomes

  1. Change in Anxiety Level

    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)

  2. Change in Stress Level

    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)

  3. Value of the Session

    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)

  4. Satisfaction With the Session

    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)

  5. Percentage of Participants That Showed Interest in a Future Session

    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

    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 - Daily

    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)

  8. Percentage of Participants by Session Frequency Preference - Weekly

    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)

  9. Percentage of Participants by Session Frequency Preference - Monthly

    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)

Other outcomes

  1. Decreased Concern Level About the COVID 19 Pandemic

    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)

07

Results

Posted Mar 2, 2022

Participant flow

Participant flow — Overall Study
MilestoneMigraine Patients/Providers/Faculty/Staff/Other
Started144
Completed144
Not completed0

Outcome measures

PrimaryHelpfulness of the Session

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)
Reported as:
Number · percentage of participants
Helpfulness of the Session
percentage of participantsMigraine Patients/Providers/Faculty/Staff/Other
Helpfulness of the Session89
PrimaryPlatform Effectiveness

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)
Reported as:
Number · percentage of participants
Platform Effectiveness
percentage of participantsMigraine Patients/Providers/Faculty/Staff/Other
Platform Effectiveness89
SecondaryChange in Anxiety Level

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)
Reported as:
Number · percentage of participants
Change in Anxiety Level
percentage of participantsMigraine Patients/Providers/Faculty/Staff/Other
Change in Anxiety Level76
SecondaryChange in Stress Level

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)
Reported as:
Number · percentage of participants
Change in Stress Level
percentage of participantsMigraine Patients/Providers/Faculty/Staff/Other
Change in Stress Level80
SecondaryValue of the Session

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)
Reported as:
Number · percentage of participants
Value of the Session
percentage of participantsMigraine Patients/Providers/Faculty/Staff/Other
Value of the Session87
SecondarySatisfaction With the Session

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)
Reported as:
Number · percentage of participants
Satisfaction With the Session
percentage of participantsMigraine Patients/Providers/Faculty/Staff/Other
Satisfaction With the Session92
SecondaryPercentage of Participants That Showed Interest in a Future Session

Percentage of participants that showed interest in a future session

Time frame:
Post-Intervention (upon completion of session up to 15 minutes)
Reported as:
Count of participants · Participants
Percentage of Participants That Showed Interest in a Future Session
ParticipantsMigraine Patients/Providers/Faculty/Staff/Other
Percentage of Participants That Showed Interest in a Future Session131
SecondaryPercentage of Participants That Would Recommend This Session to a Family Member

Percentage of participants that would recommend this session to a family member

Time frame:
Post-Intervention (upon completion of session up to 15 minutes)
Reported as:
Count of participants · Participants
Percentage of Participants That Would Recommend This Session to a Family Member
ParticipantsMigraine Patients/Providers/Faculty/Staff/Other
Percentage of Participants That Would Recommend This Session to a Family Member137
SecondaryPercentage of Participants by Session Frequency Preference - Daily

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)
Reported as:
Count of participants · Participants
Percentage of Participants by Session Frequency Preference - Daily
ParticipantsMigraine Patients/Providers/Faculty/Staff/Other
Percentage of Participants by Session Frequency Preference - Daily51
Other pre-specifiedDecreased Concern Level About the COVID 19 Pandemic

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)
Reported as:
Count of participants · Participants
Decreased Concern Level About the COVID 19 Pandemic
ParticipantsMigraine Patients/Providers/Faculty/Staff/Other
Decreased Concern Level About the COVID 19 Pandemic79
SecondaryPercentage of Participants by Session Frequency Preference - Weekly

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)
Reported as:
Count of participants · Participants
Percentage of Participants by Session Frequency Preference - Weekly
ParticipantsMigraine Patients/Providers/Faculty/Staff/Other
Percentage of Participants by Session Frequency Preference - Weekly69
SecondaryPercentage of Participants by Session Frequency Preference - Monthly

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)
Reported as:
Count of participants · Participants
Percentage of Participants by Session Frequency Preference - Monthly
ParticipantsMigraine Patients/Providers/Faculty/Staff/Other
Percentage of Participants by Session Frequency Preference - Monthly24

Adverse events

Collected over 15 minutes. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Migraine Patients/Providers/Faculty/Staff/Other0/144 (0%)0/144 (0%)0/144 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Migraine Patients/Providers/Faculty/Staff/Other
Mean48.6 ± 15.6
Sex: Female, Male
Sex: Female, Male(Participants)Migraine Patients/Providers/Faculty/Staff/Other
Female117
Male27
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Migraine Patients/Providers/Faculty/Staff/Other
American Indian or Alaska Native4
Asian16
Native Hawaiian or Other Pacific Islander0
Black or African American11
White108
More than one race0
Unknown or Not Reported5
Region of Enrollment
Region of Enrollment(participants)Migraine Patients/Providers/Faculty/Staff/Other
United States144
08

Study locations

1 site
  • Wake Forest Health Sciences
    Winston-Salem, North Carolina 27157, United States
09

References and documents

Study documents

  • Study protocol · Aug 12, 2020
  • Informed consent form · Apr 22, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04319445
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Mar 24, 2020
Start date
Mar 23, 2020
Primary completion
Jul 28, 2020
Completion
Jul 28, 2020
Results posted
Mar 2, 2022
Last update
Mar 2, 2022

Study contacts

Rebecca E Wells, MD, MPH
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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