RELAXaHEAD for Headache Patients (Phase I)
RELAXaHEAD for Headache Patients (Phase I)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- RELAXaHEAD app
Compared with
- Monitored Usual Care (MUC)
What it measured
Main measures
Number of days spent logging headache data as determined by entries into the RELAXaHEAD app
90 Days
FeasibilityNumber of days spent doing PMR as determined with the backend analytics in the RELAXaHEAD app backend analytics in the RELAXaHEAD app
90 Days
FeasibilityMinutes/day spent doing PMR as determined with the backend analytics in the RELAXaHEAD app
90 Days
FeasibilitySatisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality
Baseline
Quality of life (reported by participants)Feasibility
Who could take part
MS (type not specified) · 18 to 80
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Results
Smartphone based behavioral therapy for pain in multiple sclerosis (MS) patients: A feasibility acceptability randomized controlled study for the treatment of comorbid migraine and ms pain.Mult Scler Relat Disord · 2020
Results
Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial.Headache · 2020
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History
Started
Nov 2017
Main results due
May 2019
Finished
May 2019