Clinical trial NCT04319445: Mindfulness During COVID-19
Official title: Mindfulness During COVID-19 - Remote Mindfulness Sessions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders
Stress
Anxiety
Keywords: COVID-19
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: Helpfulness of the Session
timeFrame: Post-Intervention (upon completion of session up to 15 minutes)
measure: Platform Effectiveness
timeFrame: Post-Intervention (upon completion of session up to 15 minutes)
Secondary outcomes:
measure: Change in Anxiety Level
timeFrame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
measure: Change in Stress Level
timeFrame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
measure: Value of the Session
timeFrame: Post-Intervention (upon completion of session up to 15 minutes)
measure: Satisfaction With the Session
timeFrame: Post-Intervention (upon completion of session up to 15 minutes)
measure: Percentage of Participants That Showed Interest in a Future Session
timeFrame: Post-Intervention (upon completion of session up to 15 minutes)
measure: Percentage of Participants That Would Recommend This Session to a Family Member
timeFrame: Post-Intervention (upon completion of session up to 15 minutes)
measure: Percentage of Participants by Session Frequency Preference - Daily
timeFrame: Post-Intervention (upon completion of session up to 15 minutes)
measure: Percentage of Participants by Session Frequency Preference - Weekly
timeFrame: Post-Intervention (upon completion of session up to 15 minutes)
measure: Percentage of Participants by Session Frequency Preference - Monthly
timeFrame: Post-Intervention (upon completion of session up to 15 minutes)
Other outcomes:
measure: Decreased Concern Level About the COVID 19 Pandemic
timeFrame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rebecca E Wells, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: