Trials / Completed
CompletedNCT06414109
Mindfulness-Based Intervention for Adolescents With Chronic Migraine
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 13 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | BREATHE-Migraine | 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. |
Timeline
- Start date
- 2024-06-04
- Primary completion
- 2025-05-23
- Completion
- 2025-05-23
- First posted
- 2024-05-16
- Last updated
- 2025-07-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06414109. Inclusion in this directory is not an endorsement.