Migraine Clinical Trial
Official title:
NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
The investigators aim to determine the feasibility of a migraine self-management program.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm | Up to Month 2 | ||
Primary | Number of Days of At-Home Practice | Up to Month 2 | ||
Primary | Satisfaction Scores | Assessment of satisfaction with the intervention using a Likert scale from 1 to 5 with 1 being strongly disagree, and 5 being strongly agree; the total score is the response; higher scores indicate greater satisfaction with the intervention. | Month 2 |
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