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Behavior Therapy vs Education for Persistent Headache After Mild TBI

NCT ID: NCT07229391

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2027-10-01

Study Completion Date

2030-04-01

Brief Summary

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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

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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

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Post-Traumatic Headache

Keywords

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Headache Behavior therapy Brain Injuries, Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Headache reprocessing

Behavior therapy focused on sensations and avoidance behaviors

Group Type EXPERIMENTAL

Headache reprocessing

Intervention Type BEHAVIORAL

Behavior therapy focused on sensations and avoidance behaviors

Headache education

Education about ways to limit and manage headaches

Group Type ACTIVE_COMPARATOR

Headache education

Intervention Type BEHAVIORAL

Education about ways to limit and manage headaches

Interventions

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Headache reprocessing

Behavior therapy focused on sensations and avoidance behaviors

Intervention Type BEHAVIORAL

Headache education

Education about ways to limit and manage headaches

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel Fishbein

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

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VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Site Status

Countries

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United States

Central Contacts

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Joel Fishbein

Role: CONTACT

Phone: (858) 642-3870

Email: [email protected]

Facility Contacts

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Joel Fishbein

Role: primary

Other Identifiers

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1IK2RD001566-01A1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NURP-008-25S

Identifier Type: -

Identifier Source: org_study_id