RELAXaHEAD for Headache Patients (Phase II)

NYU Langone Health

Status: Completed

Conditions: Multiple Sclerosis; Insomnia; Migraine; Headache

Treatments: Behavioral: Smartphone-Based Progressive Muscle Relaxation Therapy (PMR); Behavioral: Monitored Usual Care (MUC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05466682

17-00525-2

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 migraine and sleep. 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. The app has been studied and findings have been reported in multiple peer reviewed publications. Also, the app has been updated based on prior feedback from the studies. Now, this 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAXaHEAD for use with patients with migraine and comorbid insomnia. . 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 migraine and insomnia (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache and sleep related outcome measures (Aim 2).

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80 years (age 18-65 in urgent care);
• Meets migraine criteria based on the International Classification of Headache Disorders (ICHD) criteria;
• Migraine Disability Assessment (MIDAS) score >5. 4+ headache days a month OR; meets chronic post- traumatic headache (PTH) criteria based on International Classification of Headache Disorders (ICHD) criteria, is 3-12 months post-injury, and there are 4+ headache days a month.
• Scoring > or = 15 on the ISI.

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;
• Unable or unwilling to follow a treatment program that relies on written and audio file materials;
• Not having a smartphone.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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48 participants in 2 patient groups

RELAX

Experimental group

Description:

Patients will receive Progressive Muscle Relaxation Therapy (PMR) via the RELAXaHEAD smart-phone app. Patients will be asked to do the following: * Week 1: 5 min deep breathing at least 5/7 days of the week * Week 2: 5 min PMR session at least 5/7 days of the week * Week 3: 15 min PMR session at least 5/7 days of the week * Week 4: PMR at least 4 days a week * Week 5: PMR at least 3 days a week * Weeks 6-8: Use PMR when it is most helpful Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the app. They will also receive written educational material about migraine.

Treatment:

Behavioral: Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)

Monitored Usual Care (MUC)

Active Comparator group

Description:

Patients will be given a general education session consisting of basic migraine information. They will receive the RELAXaHEAD app but the Progressive Muscle Relaxation Therapy (PMR) function will be blocked. Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the RELAXaHEAD app. They will also receive written educational material about migraine.

Treatment:

Behavioral: Monitored Usual Care (MUC)