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NCT Number: NCT07229391

Behavior Therapy vs Education for Persistent Headache After Mild TBI

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.

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Key information

Conditions

Post-Traumatic Headache Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Headache Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location contact

Joel Fishbein

CONTACT

[email protected]

(858) 642-3870

Joel Fishbein

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Headache reprocessing

Behavioral

Behavior therapy focused on sensations and avoidance behaviors

Headache Education

Behavioral

Education about ways to limit and manage headaches

Primary outcomes

  1. Enrollment rate

    Time frame: Typically up to 3 months, from initial referral to decision to enroll or not

    Number enrolled out of number approached

  2. Attrition

    Time frame: 12 weeks

    % of randomized who are lost to follow-up before week 12

  3. Attendance

    Time frame: During the 8-week intervention

    Percent of participants attending 80+% of sessions

  4. Homework completion

    Time frame: During the 8-week intervention

    Percent of participants completing 80+% of homework

  5. Credibility/Expectancy Questionnaire

    Time frame: Week 12

    Scale measuring how credible the intervention seemed to participants

  6. Client Satisfaction Questionnaire

    Time frame: Week 12

    Scale measuring participant satisfaction with the intervention

  7. Adverse events rated to the intervention

    Time frame: Full study period (28 weeks)

    Adverse events determined to be caused by the intervention

  8. Change in Headache Impact Test-6 score

    Time frame: Week 0 through Week 12

    A widely-used scale measuring the impact that headaches have on daily life.

Study contacts

Contact information is provided by the study sponsor or research team.

Joel Fishbein

CONTACT

[email protected]

(858) 642-3870

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Nov 17, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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