Mindfulness-Based Intervention for Adolescents With Chronic Migraine

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Migraine in Adolescence; Migraine

Treatments: Behavioral: BREATHE-Migraine

Study type: Interventional

Funder types: Other

Identifiers

NCT06414109

22-2359

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

• Weekly or bi-weekly therapy with a licensed behavioral health provider
• Major comorbid medical condition (e.g., cancer, epilepsy)
• Active psychosis or suicidal ideation
• Inability to provide consent/assent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

BREATHE-Migraine

Experimental group

Description:

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

Treatment:

Behavioral: BREATHE-Migraine