Mindfulness-Based Intervention for Adolescents With Chronic Migraine

NCT06414109 | Completed

• 1 other identifier: 22-2359
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine; Migraine in Adolescence

Keywords

Adolescent; Mindfulness; Mindfulness Intervention; Migraine; Headache

Outcome Measures

Primary Outcomes (2)

• Intervention feasibility

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

  Up to 6 weeks

• Intervention acceptability

  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)

  7 weeks

Secondary Outcomes (2)

• Change in headache-related disability

  Baseline, 6 weeks

• Change in emotion regulation

  Baseline, 6 weeks

Study Arms (1)

BREATHE-Migraine

EXPERIMENTAL

Participants will receive 6 weekly 1-hour sessions of a remotely-delivered mindfulness-based intervention in a group setting.

Behavioral: BREATHE-Migraine

Interventions

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.

BREATHE-Migraine

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

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

Study Officials

• Michelle A Clementi, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: June 4, 2024
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

US (1)