RELAXaHEAD for Headache Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Migraine Headaches, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/30/2019 |
| Start Date: | November 1, 2017 |
| End Date: | November 1, 2019 |
| Contact: | Binu Joseph |
| Email: | Binu.Joseph@nyumc.org |
| Phone: | 929.455.5625 |
The goal of this research is to assess the utility of smartphone-based progressive muscle
relaxation (PMR) for the treatment of headaches. While there are many commercially available
electronic diary and mind-body intervention apps for headache, there is little data showing
their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in
an earlier epilepsy study and beta tested with headache specialist and migraine patient
input. It also is an electric headache diary. This 2-arm randomized controlled study will
evaluate the feasibility and acceptability of RELAX for use with headache patients. One arm
will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care
(MUC) group (this group receives standard of care and uses the electronic daily symptom
reporting diary). The goals are to assess the feasibility and adherence of the RELAX
intervention in persons with headache (Aim 1) and to gather exploratory data on the effects
of the RELAX intervention on headache related outcome measures (Aim 2).
relaxation (PMR) for the treatment of headaches. While there are many commercially available
electronic diary and mind-body intervention apps for headache, there is little data showing
their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in
an earlier epilepsy study and beta tested with headache specialist and migraine patient
input. It also is an electric headache diary. This 2-arm randomized controlled study will
evaluate the feasibility and acceptability of RELAX for use with headache patients. One arm
will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care
(MUC) group (this group receives standard of care and uses the electronic daily symptom
reporting diary). The goals are to assess the feasibility and adherence of the RELAX
intervention in persons with headache (Aim 1) and to gather exploratory data on the effects
of the RELAX intervention on headache related outcome measures (Aim 2).
Inclusion Criteria:
- Meets migraine criteria based on International Classification of Headache Disorders
(ICHD) 3 beta (based on questions in RedCap
- 4 or more headache days per month
Exclusion Criteria:
- Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation
Therapy for Migraine 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
- 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
Phone: 929-455-5625
New York University School of Medicine NYU School of Medicine has a proud history that...
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