Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07513662

Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine in Adolescence Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BREATHE with Headache (BREATHE-HA)

Behavioral

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: Headache Education

Behavioral

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.

Primary outcomes

  1. Recruitment Feasibility (Primary)

    Time frame: 24 months

    ≥ 80% of adolescents screened eligible will agree to participate

Secondary outcomes

  1. Recruitment Feasibility (Secondary)

    Time frame: 24 months

    Recruit N=72; mean n=6 enrolled per month

  2. 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

  3. Intervention Adherence (Secondary)

    Time frame: 6 weeks

    >80% of adolescents will attend 5 out of 6 (80% dose) of the intervention sessions

  4. 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

  5. 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

  6. Intervention Fidelity (Secondary)

    Time frame: 6 weeks

    >95% interventionist adherence to content delivery based on fidelity checklists

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle A Clementi, Ph.D.

CONTACT

[email protected]

720-777-7487

Michelle T Harmon, B.S.

CONTACT

[email protected]

720-777-4904

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HEADS-UP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.