NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study

NYU Langone Health

Status

Completed

Conditions

Migraine

Treatments

Behavioral: Virtual Training

Behavioral: RELAXaHEAD Smartphone App

Behavioral: In-Person Training

Study type

Interventional

Funder types

Other

Identifiers

NCT06077812

22-01149

Details and patient eligibility

About

The investigators aim to determine the feasibility of a migraine self-management program.

Full 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 investigators will randomize 50 participants to an in-person migraine self-management protocol, or a remote migraine self-management protocol. The investigators will examine benefits through follow-up at 2, 4, and 6 month time points.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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