Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain (HEADS-UP)

March 30, 2026 updated by: University of Colorado, Denver

Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BREATHE with Headache (BREATHE-HA)
Mindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program
Behavioral: BREATHE 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.
Active Comparator: Enhanced Standard-of-Care: Headache Education
Headache education, delivered as a telehealth group program
Behavioral: Enhanced 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Feasibility (Primary)
Time Frame: 24 months
≥ 80% of adolescents screened eligible will agree to participate
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Feasibility (Secondary)
Time Frame: 24 months
Recruit N=72; mean n=6 enrolled per month
24 months
Retention (Secondary)
Time Frame: Post-intervention (1 week after final intervention session); 12-week follow-up
≥ 80% retained at post-intervention follow-up and 12-week follow-up
Post-intervention (1 week after final intervention session); 12-week follow-up
Intervention Adherence (Secondary)
Time Frame: 6 weeks
>80% of adolescents will attend 5 out of 6 (80% dose) of the intervention sessions
6 weeks
Acceptability (Secondary)
Time Frame: 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
Post-intervention (1 week after final intervention session)
Protocol Feasibility (Secondary)
Time Frame: 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
Baseline, post-intervention (1 week after final intervention session), 12-week follow-up
Intervention Fidelity (Secondary)
Time Frame: 6 weeks
>95% interventionist adherence to content delivery based on fidelity checklists
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Michelle A Clementi, Ph.D., University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Broderick, P. C. (2021). Learning to breathe: A mindfulness curriculum for adolescents to cultivate emotion regulation, attention, and performance. New Harbinger Publications.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-1999
  • 1K23AT013838 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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