Migraine DisordersNCT04319445
Mindfulness During COVID-19
A study testing Mindfulness session(s) in people with Migraine Disorders and Stress, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders, Stress, Anxiety
- What is being tested?
- Mindfulness session(s)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2020to 28 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any person interested in participating in the mindfulness session will be eligible to complete the pre/post surveys and participate in the mindfulness session.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
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.
- Conditions
- Migraine Disorders, Stress, Anxiety
- Being tested
- Mindfulness session(s)
- Keywords
- COVID-19
- Medical subject headings
- Migraine Disorders, Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness session(s)Behavioural
The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
| Study group | Role | What they receive |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Experimental | Not described Receives: Behavioral: Mindfulness session(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: Post-Intervention (upon completion of session up to 15 minutes)
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?"
Measured: Post-Intervention (upon completion of session up to 15 minutes)
Secondary outcomes (9)
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?"
Measured: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
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?"
Measured: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
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?"
Measured: Post-Intervention (upon completion of session up to 15 minutes)
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?"
Measured: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants That Showed Interest in a Future Session
Percentage of participants that showed interest in a future session
Measured: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants That Would Recommend This Session to a Family Member
Percentage of participants that would recommend this session to a family member
Measured: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants by Session Frequency Preference - Daily
Percentage of participants that would prefer to participate in daily similar sessions again if offered
Measured: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants by Session Frequency Preference - Weekly
Percentage of participants that would prefer to participate in weekly similar sessions again if offered
Measured: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants by Session Frequency Preference - Monthly
Percentage of participants that would prefer to participate in monthly similar sessions again if offered
Measured: Post-Intervention (upon completion of session up to 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start23 Mar 2020
- Primary completion28 Jul 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca E Wells, MD, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319445
- Sponsor's protocol ID
- IRB00064587
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2020
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness During COVID-19 - Remote Mindfulness Sessions
- ClinicalTrials.gov ID
- NCT04319445
- Acronym / sponsor ID
- IRB00064587
- Conditions
- Migraine Disorders, Stress, Anxiety
- Keywords
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Experimental | Behavioral: Mindfulness session(s) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any person interested in participating in the mindfulness session will be eligible to complete the pre/post surveys and participate in the mindfulness session.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness session(s)The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). | Behavioural | Migraine Patients/Providers/Faculty/Staff/Other |
Primary outcome
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?"
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?"
9 secondary outcomes
Change in Anxiety Level
Time frame: 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)
Value of the Session
Time frame: 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 That Showed Interest in a Future Session
Time frame: 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 by Session Frequency Preference - Daily
Time frame: 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 by Session Frequency Preference - Monthly
Time frame: Post-Intervention (upon completion of session up to 15 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca E Wells, MD, MPH principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness session(s) in people with Migraine Disorders and Stress, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helpfulness of the Session (time frame: Post-Intervention (upon completion of session up to 15 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.