Mindfulness During COVID-19

Anxiety Clinical Trial

Official title:

Mindfulness During COVID-19 - Remote Mindfulness Sessions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319445
• Other study ID #: IRB00064587
• Status: Completed
• Phase: N/A
• Start date: March 23, 2020
• Est. completion date: July 28, 2020

Study information

• Verified date: March 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• COVID-19
• Migraine Disorders
• Stress

Intervention

Behavioral:
• Mindfulness session(s)
The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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?"	Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
Primary	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?"	Post-Intervention (upon completion of session up to 15 minutes)
Primary	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?"	Post-Intervention (upon completion of session up to 15 minutes)
Secondary	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?"	Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
Secondary	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?"	Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
Secondary	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?"	Post-Intervention (upon completion of session up to 15 minutes)
Secondary	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?"	Post-Intervention (upon completion of session up to 15 minutes)
Secondary	Percentage of Participants That Showed Interest in a Future Session	Percentage of participants that showed interest in a future session	Post-Intervention (upon completion of session up to 15 minutes)
Secondary	Percentage of Participants That Would Recommend This Session to a Family Member	Percentage of participants that would recommend this session to a family member	Post-Intervention (upon completion of session up to 15 minutes)
Secondary	Percentage of Participants by Session Frequency Preference - Daily	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)
Secondary	Percentage of Participants by Session Frequency Preference - Weekly	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)
Secondary	Percentage of Participants by Session Frequency Preference - Monthly	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)