Clinical trial NCT05466682: RELAXaHEAD for Headache Patients (Phase II)
Official title: RELAXaHEAD for Headache Patients (Phase II): RELAXaHEAD for Migraine and Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Headache
Multiple Sclerosis
Insomnia
Keywords: Progressive Muscle Relaxation Therapy
Migraine
Insomnia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Center for Advancing Point of Care Technologies
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-07-20
Enrollment: 48
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 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.

Primary outcomes:
measure: Number of Patients Enrolled in the Study
timeFrame: Baseline
measure: Daily Diary Satisfaction Scores
timeFrame: Baseline
measure: Daily Diary Satisfaction Scores
timeFrame: Week 1
measure: Daily Diary Satisfaction Scores
timeFrame: Month 1
measure: Daily Diary Satisfaction Scores
timeFrame: Month 2
measure: Daily Diary Satisfaction Scores
timeFrame: Month 3
measure: Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
timeFrame: Baseline
measure: Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
timeFrame: Week 1
measure: Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
timeFrame: Month 1
measure: Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
timeFrame: Month 2
measure: Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
timeFrame: Month 3
measure: Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day
timeFrame: Up to Month 3
measure: Number of Days Participants Used Diary
timeFrame: Up to Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Mia Minen, MD
role: PRINCIPAL_INVESTIGATOR
References: