Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain

Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine

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

Mindfulness-based intervention (MBI) shows promise in adults with migraine, but research is limited in adolescents. The current study aims to advance behavioral treatments for adolescents with frequent migraine by examining an MBI that was adapted specifically for adolescents with migraine. This a pilot randomized controlled trial is designed to test feasibility and acceptability in preparation for a future efficacy trial. Adolescents with migraine will be randomized to one of two 6-week telehealth group programs: a mindfulness-based intervention (BREATHE-Headache) or Enhanced Standard-of-Care (a headache education program). Participants (and their parent/guardian) will complete assessments at baseline, immediately post-intervention, and 12-week follow up.

Inclusion Criteria:

• 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
• Stable dose (≥4 weeks) of prophylactic migraine medication or no current prophylactic medication at enrollment
• Adolescent participant fluent in English for the intervention content

Exclusion Criteria:

• 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