Mindfulness-Based Intervention for Adolescents With Chronic Migraine

Last updated: July 1, 2025
Sponsor: University of Colorado, Denver
Overall Status: Completed

Phase

N/A

Condition

Migraine (Adult)

Pain (Pediatric)

Oral Facial Pain

Treatment

BREATHE-Migraine

Clinical Study ID

NCT06414109
22-2359
  • Ages 13-18
  • All Genders

Study Summary

The goal of this study is to assess feasibility and acceptability of a mindfulness-based intervention adapted for adolescents with migraine to inform a future randomized trial assessing effects of the intervention on headache-related outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 13 to 18 years

  • Diagnosed with migraine by medical provider using criteria from the InternationalClassification of Headache Disorders, Third Edition

  • Patient report of >= 8 headache days per month

  • PedMIDAS Score of > 10 (at least mild headache-related disability)

Exclusion

Exclusion Criteria:

  • Major comorbid medical condition (e.g., cancer, epilepsy)

  • Active psychosis or suicidal ideation

  • Inability to provide consent/assent

Study Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: BREATHE-Migraine
Phase:
Study Start date:
June 04, 2024
Estimated Completion Date:
May 23, 2025

Study Description

Mindfulness-based intervention (MBI) shows promise in adults with migraine, but research is limited in adolescents. The current study aims to advance behavioral treatments for adolescents with frequent migraine by adapting an existing empirically-supported MBI for adolescents (Learning to BREATHE) to meet the unique needs of adolescents with chronic migraine. In Phase I of the study, we will use feedback solicited from interviews with teens with chronic migraine, their parents, and healthcare providers documenting the experience of living with chronic migraine and on the content and delivery of the MBI to create an adapted telehealth group intervention specifically tailored for adolescents with frequent migraine. In Phase II of the study, the adapted MBI will be piloted in a single-arm trial with adolescents with frequent migraine to assess feasibility, acceptability, and preliminary clinical signals.

Connect with a study center

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

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