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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07513662
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Sep 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Michelle A Clementi, Ph.D.
[email protected]
720-777-7487
Michelle T Harmon, B.S.
[email protected]
720-777-4904

Find similar trials in Aurora, CO

By condition
Migraine
By specialty
Neurology
By research site
Children's Hospital Colorado· Aurora, CO

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