Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Joel Fishbein (ucsd)

Description

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.

Official Title

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

Details

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.

Keywords

Persistent Posttraumatic Headache, Headache, Behavior therapy, Brain Injuries, Traumatic, Traumatic Brain Injuries, Headache reprocessing, Headache education

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Enrolled in healthcare at VA San Diego Healthcare System;
  2. History of mild TBI (mTBI), or head injury that is below the diagnostic threshold for mTBI
  3. Headache that had its lifetime onset or significantly worsened within 90 days of a concussive event
  4. Headache has persisted for at least 90 days since its onset or worsening
  5. No changes in past 3 months to medical management of headache or comorbid psychiatric symptoms, and no anticipated changes during the study interval
  6. No current participation in psychological intervention for pain or headache

You CAN'T join if...

  1. History of moderate or severe traumatic brain injury
  2. Uncontrolled bipolar, psychotic, or substance use disorder
  3. Acute suicidality as determined by screening as "high risk" or has a history of suicide attempt within the past 1 year;
  4. Other factors that would preclude participation in the study

Location

  • VA San Diego Healthcare System, San Diego, CA
    San Diego 5391811 California 5332921 92161-0002 United States

Lead Scientist at University of California Health

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT07229391
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated