Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine
University of Colorado, Denver
Summary
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. Telehealth group headache education
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 examining an MBI that was adapted specifically for adolescents with migraine. This a pilot randomized controlled trial is designed to test feasibility and acceptability in preparation for a future efficacy trial. Adolescents with migraine will be randomized to one of two 6-week telehealth group programs: a mindfulness-based intervention (BREATHE-Headache) or Enhanced Standard-of-Care…
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Currently engaged in, or previously received 4 or more sessions of behavi…
Interventions
- BehavioralBREATHE with Headache (BREATHE-HA)
BREATHE-HA is a 6-session group mindfulness-based intervention delivered via telehealth for adolescents with migraine. The intervention was adapted from an empirically-supported mindfulness-based intervention for adolescents (Learning to BREATHE; Broderick, 2021). Example activities include breath awareness, body scanning, mindful eating, loving-kindness practice, and mindful movement, as well as activities and discussion focused on improving distress tolerance and enhancing self-care, with examples related to living with migraine.
- BehavioralEnhanced Standard-of-Care: Headache Education
Enhanced Standard-of-Care is a 6-session group headache education program delivered via telehealth. It will be derived from a manual with fidelity as an attention-matched control in a behavioral trial for pediatric migraine. Headache education will include didactics and discussion on headache symptoms, medication, lifestyle factors for pain management, communication with providers, education on mood/stress, and impact of headaches on school and family.
Location
- Children's Hospital ColoradoAurora, Colorado