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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two online groups for teens ages 12 to 17 with migraines. One group teaches mindfulness, or paying attention to the present moment, and the other teaches about headaches. The study asks whether this fully online approach can work and is acceptable to teens.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 12 to 17.
  • Diagnosed with migraines by a medical provider using standard headache guidelines.
  • Report having headaches on at least 6 days each month.
  • Headaches affect daily life at least mildly, with a score above 10 on the PedMIDAS headache impact survey.
  • Take the same dose of medicine to prevent migraines for at least 4 weeks, or take no migraine prevention medicine when joining.
  • Speak and understand English fluently for the group sessions.

Who can't join

  • Currently in therapy to manage pain, such as mindfulness or therapy that teaches thinking and coping skills, or had at least 4 such sessions in the past 6 months.
  • Have a current mental health crisis, such as active thoughts of suicide.
  • Have problems with thinking or delays in development that make it hard to take part.
  • Cannot give the required permission or agreement to join the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CO