RELAXaHEAD App for Migraine

Overseen By Erin Waire

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Opioids, Barbiturates

Disqualifiers: Substance abuse, Depression, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

356 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two versions of a smartphone app called RELAXaHEAD, designed to help people manage migraines. The study will evaluate the app's effectiveness in reducing headaches and improving quality of life. Individuals who have experienced migraines for at least a year and have between 4 to 29 headache days a month may qualify. Participants will use one version of the app, which includes self-management tools with written and audio materials. As an unphased trial, participants contribute to innovative research that may enhance migraine management for many.

Will I have to stop taking my current medications?

The trial requires that you do not change your preventive medications for 3 months before starting and during the 6 weeks of the study. This means you should continue taking your current preventive medications without changes.

What prior data suggests that the RELAXaHEAD app is safe for migraine management?

Research has shown that the RELAXaHEAD Smartphone App, designed for managing migraines, is generally safe for use. Studies have found that the app's progressive muscle relaxation (PMR) feature is well-tolerated, with most users not experiencing negative effects.

One study found that the app reduced the impact of migraines, helping users manage their symptoms more effectively. Reports of serious side effects have not emerged, indicating the app's safety for migraine management. Both versions of the app focus on PMR, which has already been proven safe and effective in preventing migraines.

Overall, users can expect a safe experience with the app and may find relief from their migraines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RELAXaHEAD app because it offers a fresh approach to migraine self-management through technology. Unlike traditional migraine treatments that often involve medications like triptans or preventative drugs, the RELAXaHEAD app empowers users with digital tools to manage their migraines. Version 1 provides written materials for self-management, while Version 2 enhances this with audio resources, which can make the self-care process more engaging and personalized. This innovative use of smartphone technology could make migraine management more accessible and convenient for many people, potentially reducing reliance on medication alone.

What evidence suggests that the RELAXaHEAD app is effective for migraine?

Research has shown that the RELAXaHEAD app, which uses progressive muscle relaxation (PMR), may help people with migraines. Studies have found that this app can noticeably reduce migraine-related difficulties, leading to small to moderate improvement. Users might find it easier to manage daily tasks even during migraines. Designed for smartphones, the app offers a convenient way to manage migraines independently. In this trial, participants will receive either version 1 or version 2 of the app, both designed to provide tools to lessen the impact of migraines. ^{1 2 3 4 6}

Who Is on the Research Team?

Mia T Minen, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 16 or older who have been experiencing migraines for at least a year and have had a stable pattern of headaches ranging from 4-29 days per month. They must not plan to change their preventive medication during the study and should have a reduced quality of life due to migraines. People with recent relaxation therapy, substance abuse issues, severe depression, medication overuse headache, or those without access to a smartphone cannot participate.

Inclusion Criteria

I have had headaches for more than a year with a consistent pattern in the last 3 months.

My quality of life is significantly impacted by my condition.

You have been diagnosed with migraine according to specific guidelines mentioned in the study manual.

Exclusion Criteria

Unable or unwilling to follow a treatment program that relies on written and audio-taped materials

I have undergone CBT, Biofeedback, or Relaxation Therapy for migraine in the last year.

I have been diagnosed with headaches due to overusing medication, opioids, or barbiturates.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RELAXaHEAD app intervention for migraine self-management between baseline and weeks 3-6

6 weeks

Remote monitoring

Follow-up

Participants are monitored for persistence of effects up to 26 weeks post-treatment

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RELAXaHEAD Smartphone App Version 1
• RELAXaHEAD Smartphone App Version 2

Trial Overview The RELAXaHEAD trial is testing two versions of a smartphone app designed to help people manage their migraine symptoms. Participants will be randomly assigned one version of the app and will use it as part of their treatment routine in this remote-controlled study.

How Is the Trial Designed?

Group I: RELAX Group 1 Active Control 1 Intervention

Participants will receive access to the RELAXaHEAD app version 1 which contains certain features for migraine self-management with written materials.

Group II: RELAX Group 2 Active Control 1 Intervention

Participants will receive access to the RELAXaHEAD app version 2 which contains certain features for migraine self-management with written and audio materials.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A study involving 288 migraine patients using the RELAXaHEAD app revealed that users value the ability to track a wide range of headache-related information, including characteristics, medications, and sleep patterns, beyond standard input options.

Patients also expressed a desire to monitor coexisting conditions, adherence to behavioral therapy, and patterns of migraine triggers and relief, indicating that comprehensive tracking features can enhance user engagement and potentially improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding What People With Migraine Consider to be Important Features of Migraine Tracking: An Analysis of the Utilization of Smartphone-Based Migraine Tracking With a Free-Text Feature. Minen, MT., Jaran, J., Boyers, T., et al.[2021]

A study involving 49 participants with persistent post-traumatic headache (PPTH) showed that using a smartphone app for progressive muscle relaxation (PMR) is feasible, with 42.5% of participants continuing the practice after three months.

Despite challenges like time constraints and forgetfulness, the study suggests that smartphone-delivered PMR could be a low-cost behavioral therapy option for managing PPTH, warranting further research on its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Smartphone-Delivered Progressive Muscle Relaxation in Persistent Post-Traumatic Headache Patients. Usmani, S., Balcer, L., Galetta, S., et al.[2022]

In a pilot study of 51 adults with migraines, smartphone app-based progressive muscle relaxation (PMR) was found to be feasible and acceptable, with about half of participants using the app regularly, leading to a reduction in headache days for those who used it more frequently.

Participants who reported higher levels of depression were less likely to engage with the PMR app and diary, while those with higher anxiety levels were more likely to use them, suggesting that mental health factors can influence the effectiveness of PMR for migraine prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based migraine behavioral therapy: a single-arm study with assessment of mental health predictors. T Minen, M., Adhikari, S., K Seng, E., et al.[2020]

Progressive muscle relaxation is an effective therapeutic option for treating common conditions like tension headaches, migraines, and insomnia.

The paper provides evidence and clinical guidelines supporting the use of progressive muscle relaxation as a rational treatment alternative for these functional syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of relaxation training. Carney, RM.[2019]

The RELAXaHEAD app, designed for migraine sufferers, was found to be user-friendly and practical, with 92% of participants expressing willingness to use it again after testing its features, including a headache diary and progressive muscle relaxation (PMR).

Participants reported that the PMR feature helped improve their stress and mood, indicating its potential as a beneficial nonpharmacologic treatment option for managing chronic pain conditions like migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Design and Experience Preferences in a Novel Smartphone Application for Migraine Management: A Think Aloud Study of the RELAXaHEAD Application. Minen, MT., Jalloh, A., Ortega, E., et al.[2020]

A pilot study involving 139 adults with migraines found that a smartphone app delivering progressive muscle relaxation (PMR) was well-accepted, with participants rating its usability and willingness to engage in the intervention positively.

While the PMR group showed a greater decline in migraine-related disability scores compared to the control group, the results were not statistically significant, indicating potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial. Minen, MT., Adhikari, S., Padikkala, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8721526/

Smartphone-Delivered Progressive Muscle Relaxation for ... Smartphone-delivered PMR may be an acceptable, accessible form of therapy for migraine. Mean effects show a small-moderate mean effect size in disability ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840280

Smartphone-Based Muscle Relaxation for Migraine in the ... This randomized clinical trial evaluates whether progressive muscle relaxation smartphone-based migraine self-management improved patient ...

3. nyulangone.org nyulangone.org/news/smartphone-based-relaxation-program-reduces-disability-emergency-department-migraine-patients

Smartphone-Based Relaxation Program Reduces ... A smartphone app for muscle relaxation significantly reduced migraine-related disability in patients visiting the emergency department, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6374137/

A Think Aloud Study of the RELAXaHEAD Application Thirty percent of the participants reported doing behavioral therapy/MBI for migraine (20% Cognitive Behavioral Therapy and 10% PMR). Among the 11 participants ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03183791

RELAXaHEAD for Headache Patients (Phase I) 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 ...

6. apps.apple.com apps.apple.com/us/app/relaxahead/id1236439909

RELAXaHead on the App Store This is an app for Migraine, co-developed by Dr. Mia Minen, MD, MPH, Director of Headache Services at New-York University Langone Medical Center.