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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
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.
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.
Children's Hospital Colorado
Aurora, Colorado, United States
Recruitment Feasibility (Primary)
≥ 80% of adolescents screened eligible will agree to participate
Time frame: 24 months
Recruitment Feasibility (Secondary)
Recruit N=72; mean n=6 enrolled per month
Time frame: 24 months
Retention (Secondary)
≥ 80% retained at post-intervention follow-up and 12-week follow-up
Time frame: Post-intervention (1 week after final intervention session); 12-week follow-up
Intervention Adherence (Secondary)
\>80% of adolescents will attend 5 out of 6 (80% dose) of the intervention sessions
Time frame: 6 weeks
Acceptability (Secondary)
≥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
Time frame: Post-intervention (1 week after final intervention session)
Protocol Feasibility (Secondary)
≤10% missing daily log data and 0% missing entire questionnaires at all time points
Time frame: Baseline, post-intervention (1 week after final intervention session), 12-week follow-up
Intervention Fidelity (Secondary)
\>95% interventionist adherence to content delivery based on fidelity checklists
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.