An interventional study of BREATHE with Headache (BREATHE-HA) and Enhanced Standard-of-Care: Headache Education in Migraine and Migraine in Adolescence, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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:
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 72 is close to the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Mindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program
Behavioral: BREATHE with Headache (BREATHE-HA)
Headache education, delivered as a telehealth group program
Behavioral: Enhanced Standard-of-Care: Headache Education
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.
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
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for Aug 2028, 21 months later.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 21 months is above that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 5, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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