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Completed

NCT Number: NCT06414109

Mindfulness-Based Intervention for Adolescents With Chronic Migraine

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine in Adolescence Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 13 to 18 years
  • Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition
  • Patient report of >= 8 headache days per month
  • PedMIDAS Score of > 10 (at least mild headache-related disability)

Exclusion criteria

  • Major comorbid medical condition (e.g., cancer, epilepsy)
  • Active psychosis or suicidal ideation
  • Inability to provide consent/assent

Treatment and study plan

BREATHE-Migraine

Behavioral

The BREATHE-Migraine intervention was adapted from the research-supported curriculum, "Learning to BREATHE" (Broderick, 2021), based on qualitative feedback from adolescents with migraine, their parents, and pediatric headache providers. BREATHE-Migraine includes experiential and didactic exercises designed to address emotion regulation and the stress of living with frequent migraine.

Primary outcomes

  1. Intervention feasibility

    Time frame: Up to 6 weeks

    Percent of sessions attended; Qualitative data generated via focus group interviews (questions will include barriers and facilitators to completing the intervention)

  2. Intervention acceptability

    Time frame: 7 weeks

    Ratings on program acceptability questionnaire (higher scores indicate higher acceptability); Qualitative data generated via focus group interviews (questions will include positive and negative perceptions of the intervention)

Secondary outcomes

  1. Change in headache-related disability

    Time frame: Baseline, 6 weeks

    The Pediatric Migraine Disability Assessment (PedMIDAS) is a 6-item self-report questionnaire measuring the extent to which headaches interfered with school attendance and functioning, home functioning, and social attendance and functioning. Adolescents will be asked to indicate the number of days in the past 3 months in which they were unable to attend or fully participate in a range of activities. Lower scores indicate less disability.

  2. Change in emotion regulation

    Time frame: Baseline, 6 weeks

    The Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) is an 18-item self-report measure of various dimensions of emotion dysregulation. Items are rated on a 6-point Likert scale ranging from 1 (almost never) to 5 (almost always). The DERS-SF provides a total score and 6 subscale scores. Lower scores indicate better emotion regulation.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Children's Hospital Colorado

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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