Mindfulness vs Headache Education for Teens with Migraine
Official title: Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine
Run by University of Colorado, Denver · NCT07513662 · Data updated 2026-11-12
This study tests whether a teen-friendly mindfulness program delivered by telehealth helps adolescents with migraine as compared with a headache education program.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 17 Years |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | November 10, 2026 |
| Main results expected | August 2028 |
| Study ends | December 2028 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07513662 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adolescents aged 12-17 with diagnosed migraine, at least 6 headache days per month, and mild to moderate headache-related disability, fluent in English, with or without stable migraine prophylaxis.
✕Probably not a fit
Teens who do not respond to mindfulness or education components, or who have active psychiatric crises or other barriers to participation, may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized controlled trial compares two 6-week telehealth group interventions for adolescents with migraine: a mindfulness-based intervention adapted for teens (BREATHE-Headache) and an enhanced headache education program. The study aims to assess feasibility and acceptability for a future efficacy trial, with assessments at baseline, immediately after the program, and 12 weeks later. Participants are 12 to 17 years old with at least 6 headache days per month and mild to moderate headache-related disability, on stable migraine prophylaxis or not on prophylaxis. The trial is conducted virtually with parent/guardian involvement and analyzes outcomes to determine if this approach can be scaled for wider use.
Why it matters
Potential benefit: If successful, teens with migraine could have a readily accessible telehealth option to reduce headache impact and improve quality of life through mindfulness.
How similar studies have gone: Mindfulness-based approaches have shown promise in adults with migraine; pediatric data are limited, making this study relatively novel in the adolescent population.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Children's Hospital Colorado
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: Michelle A Clementi, Ph.D. — University of Colorado, Denver
- Study coordinator: Michelle A Clementi, Ph.D.
- Email: michelle.clementi@childrenscolorado.org
- Phone: 720-777-7487
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.