Migraine, Migraine in Adolescence
Conditions
Keywords
Adolescent, Mindfulness, Mindfulness Intervention, Migraine, Headache, Headache Education, Randomized controlled trial
Brief 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
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 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 (a headache education program). Participants (and their parent/guardian) will complete assessments at baseline, immediately post-intervention, and 12-week follow up.
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.
Sponsors
University of Colorado, Denver
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
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 behavioral interventions for pain management (e.g., mindfulness or cognitive-behavioral therapy) in the past 6 months * Current psychiatric crisis (e.g., active suicidal ideation) * Cognitive impairments or developmental delays that interfere with their ability to participate in the study * Inability to provide consent/assent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility (Primary) | 24 months | ≥ 80% of adolescents screened eligible will agree to participate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility (Secondary) | 24 months | Recruit N=72; mean n=6 enrolled per month |
| Retention (Secondary) | Post-intervention (1 week after final intervention session); 12-week follow-up | ≥ 80% retained at post-intervention follow-up and 12-week follow-up |
| Intervention Adherence (Secondary) | 6 weeks | \>80% of adolescents will attend 5 out of 6 (80% dose) of the intervention sessions |
| Acceptability (Secondary) | Post-intervention (1 week after final intervention session) | ≥80% adolescent liking/credibility ratings ≥4 (1=not at all to 5=extremely) on the adapted Program Acceptability Questionnaire; qualitative themes indicative of liking/credibility, as derived from grounded theory/qualitative analysis of adolescent focus groups at post-intervention |
| Protocol Feasibility (Secondary) | Baseline, post-intervention (1 week after final intervention session), 12-week follow-up | ≤10% missing daily log data and 0% missing entire questionnaires at all time points |
| Intervention Fidelity (Secondary) | 6 weeks | \>95% interventionist adherence to content delivery based on fidelity checklists |
Countries
United States
Contacts
CONTACTMichelle A Clementi, Ph.D.
CONTACTArlet Campuzano, B.S.
PRINCIPAL_INVESTIGATORMichelle A Clementi, Ph.D.
University of Colorado, Denver
Outcome results
None listed