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Behavioral Intervention
Mindfulness Program for Migraines
N/A
Recruiting
Led By Michelle A Clementi, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 13 to 18 years
PedMIDAS Score of > 10 (at least mild headache-related disability)
Must not have
Major comorbid medical condition (e.g., cancer, epilepsy)
Inability to provide consent/assent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if a mindfulness program for teenagers with migraines is practical and well-liked. The results will help plan a larger study to see if this program can help reduce headaches in these
Who is the study for?
This trial is for adolescents aged 13 to 18 who suffer from chronic migraines, experiencing at least 8 headache days per month and have a mild headache-related disability. They must be diagnosed with migraine by a medical provider but cannot have major health issues like cancer or epilepsy, active psychosis, suicidal thoughts, or be in frequent therapy sessions.
What is being tested?
The study is testing 'BREATHE-Migraine,' a mindfulness-based intervention tailored for teenagers with chronic migraines. The aim is to see if this approach is practical and well-received as groundwork for future trials focused on how it affects headache symptoms.
What are the potential side effects?
Since the intervention involves mindfulness practices rather than medication, there are no typical drug side effects. However, participants may experience emotional discomfort or increased awareness of pain during mindfulness exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 13 and 18 years old.
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My headaches cause some level of disability.
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I have been diagnosed with migraine by a doctor.
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I experience 8 or more headache days each month.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a major health condition like cancer or epilepsy.
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I am unable to give consent for medical procedures.
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I do not have active psychosis or thoughts of harming myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intervention acceptability
Intervention feasibility
Secondary study objectives
Change in emotion regulation
Change in headache-related disability
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BREATHE-MigraineExperimental Treatment1 Intervention
Participants will receive 6 weekly 1-hour sessions of a remotely-delivered mindfulness-based intervention in a group setting.
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,920,075 Total Patients Enrolled
1 Trials studying Migraine
48 Patients Enrolled for Migraine
Children's Hospital ColoradoOTHER
120 Previous Clinical Trials
5,133,166 Total Patients Enrolled
Michelle A Clementi, PhDPrincipal InvestigatorUniversity of Colorado, Denver