RECRUITING

BE WELL With Migraine: Brain Education and WELLness With Migraine

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. Both interventions involve 8 weekly sessions and an online platform with additional content and learning. Participants can stay on all their medications during this study. Information from this study may help determine how to better treat migraine.

Official Title

BE WELL With Migraine: Brain Education and WELLness With Migraine

Quick Facts

Study Start:2024-07-31
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05987592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of migraine with or without aura by with headache frequency of 4-20 days/month
  2. * At least 1 year of migraine
  3. * At least 18 years old
  4. * Able to participate in 8 weekly online classes
  5. * Willingness to complete baseline headache logs
  6. * Headache-related disability (Headache Impact Test (HIT)-6) score \>50
  7. * Fluent in English
  8. * Completion of technology onboarding with the online platform
  9. * Pregnant women who are less than or equal to 16 weeks gestation at enrollment are allowed to participate
  1. * Major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment.
  2. * Medication overuse headache, with migraine treatment
  3. * Pregnant women who are more than 16 weeks gestation at enrollment
  4. * Unstable migraine treatment at enrollment: any preventive treatment (oral or injectable medication or neuromodulatory device) started within 12 weeks OR acute treatment within 4 weeks to ensure stability
  5. * Unwillingness to maintain stable current medication dosages for study duration
  6. * Failure to complete baseline headache logs
  7. * Heavy alcohol and illicit drug use
  8. * Participation in another intervention clinical trial or one that would interfere in this study
  9. * Experience with stress reduction training (daily meditation practice, regular use of a mindfulness app, or prior experience with MBSR)
  10. * Any, and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study participant: COVID-positive test within 30 days of enrollment

Contacts and Locations

Study Contact

Junelyn Floyd
CONTACT
336-713-5776
jgfloyd@wakehealth.edu

Principal Investigator

Rebecca E Wells, MD, MPH
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Cambridge Health Alliance - Center for Mindfulness and Compassion
Cambridge, Massachusetts, 02141
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Rebecca E Wells, MD, MPH, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-31
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-07-31
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Migraine
  • Migraine without aura
  • Migraine with aura
  • behavioral
  • mind-body
  • integrative
  • virtual
  • online

Additional Relevant MeSH Terms

  • Migraine