Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUniversity of Colorado, Denver
About 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
Eligibility criteria
Qualifiers
Age 12 to 17 years old
Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition
Patient report of at least 6 headache days per month
At least mild headache-related disability, as assessed by PedMIDAS score > 10
Disqualifiers
Currently engaged in, or previously received 4 or more sessions of behavioral interventions for pain management (e.g., mindfulness or cognitive-behavioral therapy) in the past 6 months
Current psychiatric crisis (e.g., active suicidal ideation)
Cognitive impairments or developmental delays that interfere with their ability to participate in the study
Inability to provide consent/assent
Trial design
Treatments tested in this trial
- BREATHE with Headache (BREATHE-HA)
- Enhanced Standard-of-Care: Headache Education
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov