Phase
Condition
Headaches
Chronic Pain
Migraine (Adult)
Treatment
In-Person Training
Virtual Training
RELAXaHEAD Smartphone App
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 criteriabased 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 startuntil 3 months after beginning the study (Note - Acute medications may be changed ifneeded. Changes in preventive and acute medication and the time initiated will berecorded to evaluate the potential for medication confounds)
4-29 headache days a month (so the study includes those in whom the investigatorstypically offer preventive treatment [>4 headache days/month] and those with morefrequent migraines including chronic migraine [15 days or more/month] but excludethose with continuous headaches)
Exclusion
Exclusion Criteria:
Diagnosis of Medication Overuse Headache (MOH)
Patients who have had Cognitive Behavioral Therapy, Biofeedback, or other RelaxationTherapy for migraine in the past year
Alcohol or other substance abuse as determined by self-report or prior documentationin the medical record
Current opioid or barbiturate use
PHQ-8 scores greater than 15, indicating a conservative score of moderately severedepressive symptoms based on the PHQ-9 (in this group, more intense psychologicalintervention targeted to the depression may be needed, as depression is asignificant predictor of migraine chronification and people with migraine andcomorbid depression are more likely to be refractory to migraine treatments and todevelop medication overuse headache)
Unable or unwilling to follow a treatment program that relies on written andaudio-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 standardprotocol of biofeedback being studied
Study Design
Study Description
Connect with a study center
NYU Langone Health
New York, New York 10016
United StatesSite Not Available
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