Clinical trial NCT03183791: RELAXaHEAD for Headache Patients (Phase I)
Official title: RELAXaHEAD for Headache Patients (Phase I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Migraine
Multiple Sclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2017-06-12
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of days spent logging headache data as determined by entries into the RELAXaHEAD app
timeFrame: 90 Days
measure: Number of days spent doing PMR as determined with the backend analytics in the RELAXaHEAD app backend analytics in the RELAXaHEAD app
timeFrame: 90 Days
measure: Minutes/day spent doing PMR as determined with the backend analytics in the RELAXaHEAD app
timeFrame: 90 Days
measure: Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York Langone Health
name: Mia Minen, MD
role: PRINCIPAL_INVESTIGATOR
References: