N/A N=48 Randomized Single-blind Treatment

RELAXaHEAD for Headache Patients (Phase II)

Migraine · Headache · Multiple Sclerosis · Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT05466682 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Number of Patients Enrolled in the Study — 24; 24 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) (Behavioral); Monitored Usual Care (MUC) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Enrolled in the Study	24; 24	—
PRIMARY Daily Diary Satisfaction Scores	3.6; 3.4	—
PRIMARY Daily Diary Satisfaction Scores	3.6; 3.4	—
PRIMARY Daily Diary Satisfaction Scores	3.6; 3.4	—
PRIMARY Daily Diary Satisfaction Scores	3.6; 3.4	—
PRIMARY Daily Diary Satisfaction Scores	3.6; 3.4	—
PRIMARY Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants	3.9	—
PRIMARY Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants	3.9	—
PRIMARY Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants	3.9	—
PRIMARY Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants	3.9	—
PRIMARY Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants	3.9	—
PRIMARY Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day	22.1	—
PRIMARY Number of Days Participants Used Diary	54.58; 62.08	—

Summary

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).

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05466682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.