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

Withdrawn before enrolling · Phase 4

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT02945839

Run by

NYU Langone Health

People needed

0

Starts

2016-12-28

Expected to finish

2019-12-01

Last updated by the study team

2019-11-29

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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