Behavior Therapy vs Education for Persistent Headache After Mild TBI

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-Traumatic Headache
• Intervention / Treatment: Behavioral: Headache reprocessing; Behavioral: Headache education

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joel Fishbein; Phone Number: (858) 642-3870; Email: joel.fishbein2@va.gov

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161-0002
      • VA San Diego Healthcare System, San Diego, CA
      • Contact: Joel Fishbein; Phone Number: (858) 642-3870; Email: joel.fishbein2@va.gov
      • Principal Investigator: Joel Fishbein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Headache reprocessing; Behavior therapy focused on sensations and avoidance behaviors	Behavioral: Headache reprocessing; Behavior therapy focused on sensations and avoidance behaviors
Active Comparator: Headache education; Education about ways to limit and manage headaches	Behavioral: Headache education; Education about ways to limit and manage headaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	Number enrolled out of number approached	Typically up to 3 months, from initial referral to decision to enroll or not
Attrition	% of randomized who are lost to follow-up before week 12	12 weeks
Attendance	Percent of participants attending 80+% of sessions	During the 8-week intervention
Homework completion	Percent of participants completing 80+% of homework	During the 8-week intervention
Credibility/Expectancy Questionnaire	Scale measuring how credible the intervention seemed to participants	Week 12
Client Satisfaction Questionnaire	Scale measuring participant satisfaction with the intervention	Week 12
Adverse events rated to the intervention	Adverse events determined to be caused by the intervention	Full study period (28 weeks)
Change in Headache Impact Test-6 score	A widely-used scale measuring the impact that headaches have on daily life.	Week 0 through Week 12

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Joel Fishbein, VA San Diego Healthcare System, San Diego, CA

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: November 12, 2025
• First Submitted That Met QC Criteria: November 12, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Headache; Brain Injuries, Traumatic; Behavior therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Headache Disorders; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Headache Disorders, Secondary; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Brain Injuries, Traumatic; Headache; Post-Traumatic Headache
• Other Study ID Numbers: NURP-008-25S; 1IK2RD001566-01A1 (Other Grant/Funding Number: VA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Final datasets in machine-readable format will be shared via PubMed Central
• IPD Sharing Time Frame: Available upon study completion, indefinite
• IPD Sharing Access Criteria: Public access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No