NCT07513662 Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
| NCT ID | NCT07513662 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2026-11-10 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2026-11-10 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Michelle A Clementi, Ph.D.
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT07513662 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07513662 currently recruiting?
Yes, NCT07513662 is actively recruiting participants. Contact the research team at michelle.clementi@childrenscolorado.org for enrollment information.
Where is the NCT07513662 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT07513662 clinical trial?
NCT07513662 is sponsored by University of Colorado, Denver. The principal investigator is Michelle A Clementi, Ph.D. at University of Colorado, Denver. The trial plans to enroll 72 participants.
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