Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
HEADS-UP
Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine
2 other identifiers
interventional
72
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2026
CompletedFirst Posted
Study publicly available on registry
April 7, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
Study Completion
Last participant's last visit for all outcomes
December 1, 2028
August 10, 2026
August 1, 2026
1.8 years
March 19, 2026
August 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recruitment Feasibility (Primary)
≥ 80% of adolescents screened eligible will agree to participate
24 months
Secondary Outcomes (6)
Recruitment Feasibility (Secondary)
24 months
Retention (Secondary)
Post-intervention (1 week after final intervention session); 12-week follow-up
Intervention Adherence (Secondary)
6 weeks
Acceptability (Secondary)
Post-intervention (1 week after final intervention session)
Protocol Feasibility (Secondary)
Baseline, post-intervention (1 week after final intervention session), 12-week follow-up
- +1 more secondary outcomes
Study Arms (2)
BREATHE with Headache (BREATHE-HA)
EXPERIMENTALMindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program
Enhanced Standard-of-Care: Headache Education
ACTIVE COMPARATORHeadache education, delivered as a telehealth group program
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Related Publications (1)
Broderick, P. C. (2021). Learning to breathe: A mindfulness curriculum for adolescents to cultivate emotion regulation, attention, and performance. New Harbinger Publications.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle A Clementi, Ph.D.
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2026
First Posted
April 7, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
August 10, 2026
Record last verified: 2026-08