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Not yet recruiting NCT07513662

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

No phase Interventional Migraine Migraine in Adolescence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BREATHE with Headache (BREATHE-HA), Enhanced Standard-of-Care: Headache Education.
Who it may be relevant to
Registry conditions: Migraine, Migraine in Adolescence. Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

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 exam
  • 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.

Primary outcome measures

  • Recruitment Feasibility (Primary) [Time frame: 24 months]
Secondary outcome measures (6)
  • Recruitment Feasibility (Secondary) [Time frame: 24 months]
  • Retention (Secondary) [Time frame: Post-intervention (1 week after final intervention session); 12-week follow-up]
  • Intervention Adherence (Secondary) [Time frame: 6 weeks]
  • Acceptability (Secondary) [Time frame: 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]
  • Intervention Fidelity (Secondary) [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Children's Hospital Colorado — Aurora

Publications

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

Identifiers

NCT: NCT07513662 · 25-1999 · 1K23AT013838

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗