ClinicalTrials.gg
Not yet recruitingNCT07229391Updated Dec 26, 2025

Behavior Therapy vs Education for Persistent Headache After Mild TBI

An interventional study of Headache reprocessing and Headache education in Post-Traumatic Headache, sponsored by VA Office of Research and Development. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Post-Traumatic Headache

Keywords

  • Headache
  • Behavior therapy
  • Brain Injuries, Traumatic
03

In context

Post-Traumatic Headache

192 studies on the registry are indexed under Post-Traumatic Headache; 54 are open to participants now.

This study's planned enrollment of 60 is above the median of 44 across 169 interventional studies indexed under Post-Traumatic Headache.

Browse Post-Traumatic Headache studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Headache reprocessing

    Behavior therapy focused on sensations and avoidance behaviors

    Behavioral: Headache reprocessing

  • Active comparator
    Headache education

    Education about ways to limit and manage headaches

    Behavioral: Headache education

Interventions

  • BehavioralHeadache reprocessing

    Behavior therapy focused on sensations and avoidance behaviors

  • BehavioralHeadache education

    Education about ways to limit and manage headaches

06

What researchers measure

Primary outcomes

  1. Enrollment rate

    Number enrolled out of number approached

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

  2. Attrition

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

    Time frame: 12 weeks

  3. Attendance

    Percent of participants attending 80+% of sessions

    Time frame: During the 8-week intervention

  4. Homework completion

    Percent of participants completing 80+% of homework

    Time frame: During the 8-week intervention

  5. Credibility/Expectancy Questionnaire

    Scale measuring how credible the intervention seemed to participants

    Time frame: Week 12

  6. Client Satisfaction Questionnaire

    Scale measuring participant satisfaction with the intervention

    Time frame: Week 12

  7. Adverse events rated to the intervention

    Adverse events determined to be caused by the intervention

    Time frame: Full study period (28 weeks)

  8. Change in Headache Impact Test-6 score

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

    Time frame: Week 0 through Week 12

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Final datasets in machine-readable format will be shared via PubMed Central

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Available upon study completion, indefinite

Access criteria: Public access

Data sharing details ↗ · pmc.ncbi.nlm.nih.gov

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07229391
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Oct 1, 2027 (estimated)
Primary completion
Jan 1, 2030 (estimated)
Completion
Apr 1, 2030 (estimated)
Last update
Dec 26, 2025

Study contacts

Joel Fishbein
Contact
joel.fishbein2@va.gov
(858) 642-3870
Joel Fishbein
principal investigator · VA San Diego Healthcare System, San Diego, CA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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