Post-Traumatic HeadacheNCT07229391
Behavior Therapy vs Education for Persistent Headache After Mild TBI
A study testing Headache reprocessing and Headache education in people with Post-Traumatic Headache, run by VA Office of Research and Development at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Headache
- What is being tested?
- Headache reprocessing and Headache education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2027to 1 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Joel Fishbein, (858) 642-3870, joel.fishbein2@va.gov
Joel Fishbein
About this study
Official title: 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.
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.
- Conditions
- Post-Traumatic Headache
- Being tested
- Headache reprocessing, Headache education
- Keywords
- Headache, Behavior therapy, Brain Injuries, Traumatic
- Medical subject headings
- Post-Traumatic Headache, Headache, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headache reprocessingBehavioural
Behavior therapy focused on sensations and avoidance behaviors
Headache educationBehavioural
Education about ways to limit and manage headaches
| Study group | Role | What they receive |
|---|---|---|
| Headache reprocessing | Experimental | Behavior therapy focused on sensations and avoidance behaviors Receives: Behavioral: Headache reprocessing |
| Headache education | Active comparator | Education about ways to limit and manage headaches Receives: Behavioral: Headache education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Number enrolled out of number approached
Measured: 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
Measured: 12 weeks
Attendance
Percent of participants attending 80+% of sessions
Measured: During the 8-week intervention
Homework completion
Percent of participants completing 80+% of homework
Measured: During the 8-week intervention
Credibility/Expectancy Questionnaire
Scale measuring how credible the intervention seemed to participants
Measured: Week 12
Client Satisfaction Questionnaire
Scale measuring participant satisfaction with the intervention
Measured: Week 12
Adverse events rated to the intervention
Adverse events determined to be caused by the intervention
Measured: 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.
Measured: Week 0 through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Oct 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joel Fishbein, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229391
- Sponsor's protocol ID
- NURP-008-25S
- Other IDs
- 1IK2RD001566-01A1
- Status last verified
- Dec 2025
- First submitted
- 12 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final datasets in machine-readable format will be shared via PubMed Central
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining a Novel Treatment for Persistent Headache After Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07229391
- Acronym / sponsor ID
- NURP-008-25S
- Conditions
- Post-Traumatic Headache
- Keywords
- Headache, Behavior therapy, Brain Injuries, Traumatic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Headache reprocessing | Experimental | Behavioral: Headache reprocessingBehavior therapy focused on sensations and avoidance behaviors |
| Headache education | Active comparator | Behavioral: Headache educationEducation about ways to limit and manage headaches |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Headache reprocessingBehavior therapy focused on sensations and avoidance behaviors | Behavioural | Headache reprocessing |
| Headache educationEducation about ways to limit and manage headaches | Behavioural | Headache education |
Primary outcome
Enrollment rate
Time frame: Typically up to 3 months, from initial referral to decision to enroll or not
Number enrolled out of number approached
Attrition
Time frame: 12 weeks
% of randomized who are lost to follow-up before week 12
Attendance
Time frame: During the 8-week intervention
Percent of participants attending 80+% of sessions
Homework completion
Time frame: During the 8-week intervention
Percent of participants completing 80+% of homework
Credibility/Expectancy Questionnaire
Time frame: Week 12
Scale measuring how credible the intervention seemed to participants
Client Satisfaction Questionnaire
Time frame: Week 12
Scale measuring participant satisfaction with the intervention
Adverse events rated to the intervention
Time frame: Full study period (28 weeks)
Adverse events determined to be caused by the intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Yes. Final datasets in machine-readable format will be shared via PubMed Central
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joel Fishbein principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headache reprocessing and Headache education in people with Post-Traumatic Headache, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joel Fishbein ((858) 642-3870, joel.fishbein2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: Typically up to 3 months, from initial referral to decision to enroll or not). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.