Mindfulness intervention for teens with chronic migraine
Mindfulness-Based Intervention for Adolescents With Chronic Migraine
This study is testing a mindfulness program for teenagers with chronic migraines to see if it helps them feel better and is easy for them to use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06414109 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and acceptability of a mindfulness-based intervention specifically designed for adolescents suffering from chronic migraine. The intervention, adapted from an existing program called Learning to BREATHE, will be tailored to address the unique challenges faced by this age group. In the first phase, feedback will be gathered from interviews with adolescents, their parents, and healthcare providers to refine the intervention. The second phase will involve piloting the adapted program in a single-arm trial to assess its feasibility and preliminary clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 13 to 18 years who experience frequent migraines, defined as at least 8 headache days per month.
Not a fit: Patients who are currently receiving weekly or bi-weekly therapy with a licensed behavioral health provider may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide adolescents with effective coping strategies to manage their chronic migraine symptoms.
How similar studies have performed: While mindfulness-based interventions have shown promise in adults with migraine, this specific adaptation for adolescents is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Michelle A Clementi, PhD — University of Colorado, Denver
- Study coordinator: Michelle A Clementi, PhD
- Email: michelle.clementi@childrenscolorado.org
- Phone: 720-777-7487
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.