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

NCT07513662 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-04-07

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Michelle A Clementi, Ph.D. · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-06-30
Completion
2028-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07513662 on ClinicalTrials.gov