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NCT07513662
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
Conditions: Migraine, Migraine in Adolescence
Sex: All
Ages: 12 Years – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 72
Sponsor: University of Colorado, Denver
Location: Children's Hospital Colorado Aurora Colorado
Summary
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
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
Source: ClinicalTrials.gov (NCT07513662). StuddyBuddy aggregates publicly available trial information.