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Behavioral Intervention

RELAXaHEAD App for Migraine

N/A

Recruiting

Led By Mia T Minen, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥16 years of age

Must not have

Diagnosis of medication overuse headache and/or opioid or barbiturate use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 6

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new app that may help people with migraine. It uses remote control and can be done from home.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves using an app rather than medication, traditional side effects are not expected. However, participants may experience frustration or lack satisfaction if they find the technology difficult to use or ineffective.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 16 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) Score

Secondary study objectives

Change in Migraine Specific Quality of Life (MSQ) Version 2 Scores

Change in Monthly Headache Days (MHDs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: RELAX Group 1Active Control1 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 2Active Control1 Intervention

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

0 / 2Eligibility criteria met