Clinical trial NCT06077812: NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
Official title: NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migraine
Self-Management
Headache
Behavioral Intervention
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm
timeFrame: Up to Month 2
measure: Number of Days of At-Home Practice
timeFrame: Up to Month 2
measure: Satisfaction Scores
timeFrame: Month 2
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Mia T Minen, MD
role: PRINCIPAL_INVESTIGATOR
References: