NCT07229391

Behavior Therapy vs Education for Persistent Headache After Mild TBI

Examining a Novel Treatment for Persistent Headache After Mild Traumatic Brain Injury

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test a new treatment, called Headache reprocessing, for persistent post-traumatic headache. The new treatment will be compared to a headache education intervention. The main objectives of the study are to examine the feasibility, safety, and clinical appropriateness of the new treatment.

Detailed description

Persistent post-traumatic headache (PPTH) is a common, debilitating health condition affecting Veterans and civilians. Relative to other headache disorders, PPTH is especially severe and impairing. PPTH has no established first-line treatments at this time. This research seeks to develop a new behavioral treatment, called headache reprocessing, to target fear and avoidance behaviors and cognitions, and associated neural changes, that drive PPTH. This trial will test the feasibility, safety, and clinical appropriateness of Headache Reprocessing Therapy by comparing it to a headache education control condition in a randomized controlled trial. We will randomize 60 Veterans with PPTH to take part in this study. Headache reprocessing and the educational control intervention will be delivered in group format over eight sessions (one per week for eight weeks). This intervention has the potential to improve available treatment options for PPTH.

Conditions

• Post-Traumatic Headache

Interventions

Type	Name	Description
BEHAVIORAL	Headache reprocessing	Behavior therapy focused on sensations and avoidance behaviors
BEHAVIORAL	Headache education	Education about ways to limit and manage headaches

Timeline

• Start date: 2027-10-01
• Primary completion: 2030-01-01
• Completion: 2030-04-01
• First posted: 2025-11-17
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States