Behavior Therapy vs Education for Persistent Headache After Mild TBI

Official title

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

Overview

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.

Interventions

• Behavioral Headache reprocessing
  Behavior therapy focused on sensations and avoidance behaviors
• Behavioral Headache education
  Education about ways to limit and manage headaches

Primary outcome measures

• Enrollment rate [Time frame: Typically up to 3 months, from initial referral to decision to enroll or not]
• Attrition [Time frame: 12 weeks]
• Attendance [Time frame: During the 8-week intervention]
• Homework completion [Time frame: During the 8-week intervention]
• Credibility/Expectancy Questionnaire [Time frame: Week 12]
• Client Satisfaction Questionnaire [Time frame: Week 12]
• Adverse events rated to the intervention [Time frame: Full study period (28 weeks)]
• Change in Headache Impact Test-6 score [Time frame: Week 0 through Week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• VA San Diego Healthcare System, San Diego, CA — San Diego

Identifiers

NCT: NCT07229391 · NURP-008-25S · 1IK2RD001566-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗