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Telehealth Interventions for Adolescent Migraine

This study is testing two different telehealth group programs for adolescents (ages 12-17) who experience frequent migraines (severe headaches). One program is called BREATHE with Headache (BREATHE-HA), which uses mindfulness strategies. The other program is Enhanced Standard-of-Care: Headache Education, which focuses on teaching about headaches. The main goal of this study is to see if it's practical and acceptable to run a virtual study comparing these two programs. You might be able to join if you are 12-17 years old, have been diagnosed with migraine by a doctor, have at least 6 headache days per month, and experience at least mild headache-related disability. The study is currently unclear on its recruitment status.

Study design
This is a pilot randomized controlled trial with 72 participants. You would be randomly assigned to one of two 6-week telehealth group programs.
What's involved
You would participate in one of two 6-week telehealth group programs. You (and your parent/guardian) would complete assessments at the start, right after the program, and 12 weeks later.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for 12 weeks after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07513662

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

Not Yet Recruiting
NAAges 12–17InterventionalTreatment
University of Colorado, Denver
~72 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:BREATHE with Headache (BREATHE-HA)Enhanced Standard-of-Care: Headache Education

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment Feasibility (Primary)
Measured over 24 months

Conditions

Migraine
Migraine in Adolescence

Explore related trials

Migraine

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Michelle A Clementi, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Michelle A Clementi, Ph.D.
[email protected]
720-777-7487
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Recruitment Feasibility (Primary)24 months

    ≥ 80% of adolescents screened eligible will agree to participate