Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

• Status: Withdrawn
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Collectively, evidence shows that a combination of medication and behavioral therapy is most effective for migraine care. The ED is a critical point of contact with the health care system for many migraine patients; in current practice, it is a missed opportunity to initiate and establish a comprehensive migraine management paradigm. Behavioral headache treatments (e.g., progressive muscle relaxation (PMR), biofeedback, cognitive-behavioral therapy (CBT)) are effective migraine treatment options that are essentially free of side effects. PMR has also been successful as a technique that patients can do independently. Studies have shown that combination pharmacological-behavioral therapy is most effective for migraine treatment.

Several aspects of this study are innovative, including: 1. Initiation of preventive medication in a timely manner for migraineurs who present to the ED. 2. Introduction of PM+PMR in the ED at a time that can serve as a teachable moment. 3. Introduction of a smartphone application-based product (a minimal contact based behavioral therapy) in the ED setting to reduce headache disability, frequency, and intensity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Naproxen; Topiramate

Criteria

Inclusion Criteria:

• Meets migraine criteria based on Information in Study Manual or based on Headache expert opinion -4+ migraines a month

• Migraine Disability Assessment (MIDAS) score >5.

Exclusion Criteria:

• Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy in the past year;

• Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy; Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record;

• Opioid or barbiturate use 10+ days a month;

• PHQ9 score of severe depression;

• Unable or unwilling to follow a treatment program that relies on written and audio recorded materials;

• Not having a smartphone.