Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Migraine Headaches, Hospital |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 12/26/2018 |
| Start Date: | March 2019 |
| End Date: | March 2019 |
| Contact: | Liliana Serrano |
| Email: | Liliana.Serrano2@nyumc.org |
| Phone: | 212 685 4070 |
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.
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.
Investigators will conduct a randomized trial to evaluate the impact of a comprehensive
migraine treatment program on the quality of life for migraineurs with frequent and disabling
headaches who present to the ED. The intervention (PM+PMR) will combine acute treatment,
migraine preventive medication-topiramate, and the APP with PMR. Data from patients in the
intervention group will be compared with data from an enhanced usual care (EUC) group to
examine the efficacy of the combined treatment effects.
migraine treatment program on the quality of life for migraineurs with frequent and disabling
headaches who present to the ED. The intervention (PM+PMR) will combine acute treatment,
migraine preventive medication-topiramate, and the APP with PMR. Data from patients in the
intervention group will be compared with data from an enhanced usual care (EUC) group to
examine the efficacy of the combined treatment effects.
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.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: mia Minen, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
Click here to add this to my saved trials
