NCT06077838

RELAXaHEAD for Headache Patients (Phase III)

A Single-Center Phase 3 Study of RELAXaHEAD: A Behavioral Approach to Remote Migraine Management in Primary Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 356 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients with migraine seen across diverse primary care practices (through three different affiliated hospitals and one of the largest family health center groups in the country) will be identified via an electronic medical record system. The investigators will randomize 356 participants and examine the potential benefits to two different smartphone based interventions between baseline and weeks 3-6. The investigators will also examine the persistence of effects up to 26 weeks post-treatment, mediators to explore mechanisms, and moderators to identify subgroups of patients for whom the intervention seems most effective.

Conditions

• Migraine

Interventions

Type	Name	Description
BEHAVIORAL	RELAXaHEAD Smartphone App Version 1	RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts.
BEHAVIORAL	RELAXaHEAD Smartphone App Version 2	RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts. This version also contains audio materials.

Timeline

• Start date: 2023-11-08
• Primary completion: 2028-08-31
• Completion: 2028-08-31
• First posted: 2023-10-11
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States