RELAXaHEAD for Headache Patients (Phase II)

NCT ID: NCT05466682

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2023-06-19

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).

Conditions

Migraine; Headache; Multiple Sclerosis; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RELAX

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.

Group Type: EXPERIMENTAL

Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)

Intervention Type: BEHAVIORAL

Relaxation technique delivered via RELAXaHEAD app.

Monitored Usual Care (MUC)

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.

Group Type: ACTIVE_COMPARATOR

Monitored Usual Care (MUC)

Intervention Type: BEHAVIORAL

Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary.

Interventions

Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)

Relaxation technique delivered via RELAXaHEAD app.

Intervention Type: BEHAVIORAL

Monitored Usual Care (MUC)

Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Advancing Point of Care Technologies

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mia Minen, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-00525-2

Identifier Type: -

Identifier Source: org_study_id