Status:
COMPLETED
NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
Lead Sponsor:
NYU Langone Health
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators aim to determine the feasibility of a migraine self-management program.
Detailed Description
Patients with migraine seen by neurologists/headache specialists within or affiliated with the NYU Langone Health system will be identified via electronic medical record system, or in person. The inve...
Eligibility Criteria
Inclusion
- English speaking. (At this time, the validated app is only available in English.)
- 18-65 years of age
- Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on a headache specialist or neurologist
- Headaches for ≥1 year
- Has not begun a new migraine preventative medication in the last month
- Agreement to not make any preventive medication changes from the time of trial start until 3 months after beginning the study (Note - Acute medications may be changed if needed. Changes in preventive and acute medication and the time initiated will be recorded to evaluate the potential for medication confounds)
- 4-29 headache days a month (so the study includes those in whom the investigators typically offer preventive treatment \[\>4 headache days/month\] and those with more frequent migraines including chronic migraine \[15 days or more/month\] but exclude those with continuous headaches)
Exclusion
- Diagnosis of Medication Overuse Headache (MOH)
- Patients who have had Cognitive Behavioral Therapy, Biofeedback, or other Relaxation Therapy for migraine in the past year
- Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
- Current opioid or barbiturate use
- PHQ-8 scores greater than 15, indicating a conservative score of moderately severe depressive symptoms based on the PHQ-9 (in this group, more intense psychological intervention targeted to the depression may be needed, as depression is a significant predictor of migraine chronification and people with migraine and comorbid depression are more likely to be refractory to migraine treatments and to develop medication overuse headache)
- Unable or unwilling to follow a treatment program that relies on written and audio-taped materials
- Coronary heart disease, heart attack, stroke, diabetes mellitus Type 1 or II
- Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)
- Other physical limitations which would prevent participating in the standard protocol of biofeedback being studied
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06077812
Start Date
November 27 2023
End Date
December 10 2024
Last Update
December 16 2024
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016