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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: BREATHE with Headache (BREATHE-HA) for 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.

Official registry: https://clinicaltrials.gov/study/NCT07513662 · University of Colorado, Denver · enrollment listed as 72

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are BREATHE with Headache (BREATHE-HA), or Enhanced Standard-of-Care: Headache Education. The registry lists allocation as randomized. 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.

They plan to enroll about 72 people at Aurora. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

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

Interventions: BREATHE with Headache (BREATHE-HA), Enhanced Standard-of-Care: Headache Education

Primary outcome (registry wording): Recruitment Feasibility (Primary)

Who it is for (from inclusion criteria)

  • Ages 12 Years to 17 Years
  • 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

Public study contact (from the registry)

Michelle A Clementi, Ph.D.

720-777-7487

michelle.clementi@childrenscolorado.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT07513662 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07513662?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07513662?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary