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

Trial Summary

What is the purpose of this trial?

This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.

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 data supports the effectiveness of the RELAXaHEAD App treatment for migraine?

Research shows that Progressive Muscle Relaxation (PMR), a key component of the RELAXaHEAD App, is an effective treatment for reducing migraine days. In a study, high users of PMR through the app experienced 4 fewer headache days in the second month compared to the first month, indicating its potential benefit in managing migraines. ^{1 2 3 4 5}

Is the RELAXaHEAD app safe for use in humans?

The RELAXaHEAD app, which uses Progressive Muscle Relaxation (PMR) therapy, has been studied in people with migraines and post-traumatic headaches. No safety concerns were reported in these studies, suggesting it is generally safe for use in humans. ^{1 2 3 5 6}

How is the RELAXaHEAD App treatment for migraines different from other treatments?

The RELAXaHEAD App is unique because it offers a smartphone-based approach to migraine management using Progressive Muscle Relaxation (PMR), a non-drug therapy that helps relax muscles to reduce stress and tension, which can trigger migraines. This app also includes a headache diary feature, allowing users to track their symptoms and treatment progress conveniently. ^{1 2 3 5 6}

Research Team

Mia T Minen, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

I speak English.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Smartphone-based migraine behavioral therapy: a single-arm study with assessment of mental health predictors. [2020]

2. England 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. [2020]

3. United States 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical applications of relaxation training. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Smartphone-Delivered Progressive Muscle Relaxation in Persistent Post-Traumatic Headache Patients. [2022]