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

NCT06077812 | Completed

• 1 other identifier: 22-01149
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine

Keywords

Migraine; Self-Management; Headache; Behavioral Intervention

Outcome Measures

Primary Outcomes (3)

• Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm

  Up to Month 2

• Number of Days of At-Home Practice

  Up to Month 2

• 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

Study Arms (2)

In-Person Migraine Self-Management

ACTIVE COMPARATOR

Behavioral: RELAXaHEAD Smartphone App; Behavioral: In-Person Training

Remote Migraine Self-Management

ACTIVE COMPARATOR

Behavioral: RELAXaHEAD Smartphone App; Behavioral: Virtual Training

Interventions

RELAXaHEAD Smartphone App BEHAVIORAL

Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.

In-Person Migraine Self-Management; Remote Migraine Self-Management

In-Person Training BEHAVIORAL

Participants will receive in-person training in migraine self-management techniques.

In-Person Migraine Self-Management

Virtual Training BEHAVIORAL

Participants will receive virtual training in migraine self-management techniques.

Remote Migraine Self-Management

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking. (At this time, the validated app is only available in English.)
• 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)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mia T Minen, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: November 27, 2023
• Primary Completion: August 6, 2024
• Study Completion: December 10, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Dr. Mia Minen (Mia.Minen@nyulangone.org). To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)