Recruiting

Mindfulness & Education

Sponsor:

University of Colorado, Denver

Code:

NCT07513662

Conditions

Migraine

Migraine in Adolescence

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

BREATHE with Headache (BREATHE-HA)

Enhanced Standard-of-Care: Headache Education

Study Details

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

Conditions

Migraine

Migraine in Adolescence

Study ID

NCT07513662

Start date

Nov 10, 2026

Status verified date

Nov, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BREATHE with Headache (BREATHE-HA)

Mindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program

active comparator: Enhanced Standard-of-Care: Headache Education

Headache education, delivered as a telehealth group program

Interventions

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.

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.

Primary outcome measure

  • Recruitment Feasibility (Primary) [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Michelle A Clementi, Ph.D.

720-777-7487michelle.clementi@childrenscolorado.org

Arlet Campuzano, B.S.

arlet.campuzano@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Michelle A Clementi, Ph.D.

720-777-7487michelle.clementi@childrenscolorado.org

Arlet Campuzano, B.S.

720-777-4904arlet.campuzano@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Keywords

  • Adolescent
  • Mindfulness
  • Mindfulness Intervention
  • Migraine
  • Headache
  • Headache Education
  • Randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.