Mindfulness vs Education for Migraine
(HEADS-UP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this study (supported by and included in the NIH HEAL Initiative: https://heal.nih.gov/) is to learn if a fully virtual study comparing two telehealth group interventions for adolescents with migraine is feasible and acceptable:
1. Telehealth group mindfulness-based intervention
2. Telehealth group headache education
Who Is on the Research Team?
Michelle A Clementi, Ph.D.
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to a 6-week telehealth group program: either a mindfulness-based intervention or headache education
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BREATHE with Headache (BREATHE-HA)
- Enhanced Standard-of-Care: Headache Education
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Mindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program
Headache education, delivered as a telehealth group program
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
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