RELAXaHEAD for Headache Patients (Phase I)

NYU Langone Health

Status: Completed

Conditions: Multiple Sclerosis; Migraine; Headache

Treatments: Behavioral: RELAXaHEAD app; Behavioral: Monitored Usual Care (MUC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03183791

17-00525

Details and patient eligibility

About

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).

Enrollment: 402 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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402 participants in 2 patient groups

RELAX group

Experimental group

Treatment:

Behavioral: RELAXaHEAD app

Monitored Usual Care (MUC) group

Active Comparator group

Treatment:

Behavioral: Monitored Usual Care (MUC)