Headache Reprocessing for Post-Traumatic Headache

Overseen By Joel Fishbein

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Moderate/severe TBI, Uncontrolled bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called headache reprocessing for individuals with long-lasting headaches following a mild head injury. It compares this treatment, which emphasizes behavior changes, to a program focused on headache management education. The trial aims to assess the safety and suitability of the new treatment for these headaches. Individuals who have experienced a mild head injury and have persistent headaches that began or worsened within 90 days of the injury may be suitable candidates for this study. As an unphased trial, it provides participants the chance to contribute to innovative research that could lead to new methods for managing persistent headaches.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it requires no changes in your headache or psychiatric medication management for the past 3 months and no changes during the study.

What prior data suggests that headache reprocessing is safe for treating post-traumatic headache?

Research shows limited information specifically about the safety of headache reprocessing therapy for post-traumatic headaches. Since this trial is in the "not applicable" phase, the treatment remains in the early stages of research. This phase usually indicates that the treatment is considered safe enough for testing in a controlled study, though complete safety details may not yet be available.

In studies on other headache treatments, such as erenumab (a drug for preventing migraines), about 28% of patients experienced fewer headache days without major safety issues. Although this data does not directly pertain to headache reprocessing, it demonstrates that treatments for post-traumatic headaches are being explored with safety in mind.

Overall, while detailed safety data for headache reprocessing is lacking, its testing suggests potential safety. Participants should discuss any concerns with the study team to understand the safety measures in place. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about headache reprocessing because it approaches post-traumatic headaches in a novel way. Unlike standard treatments that often rely on medication to manage symptoms, headache reprocessing focuses on behavior therapy. This method helps patients reframe their sensations and tackle avoidance behaviors, potentially leading to long-term relief without the side effects associated with drugs. By addressing the psychological components of headache management, this technique offers a fresh, holistic alternative that could complement or even replace conventional approaches.

What evidence suggests that headache reprocessing might be an effective treatment for post-traumatic headache?

This trial will compare headache reprocessing with headache education for post-traumatic headaches. Research shows that headache reprocessing, a new behavioral treatment, aims to help individuals with post-traumatic headaches by altering their response to and avoidance of pain. Although specific data on headache reprocessing is not yet available, similar behavioral methods have shown promise. For instance, lifestyle changes have led to a 36% reduction in headache frequency and a 56% decrease in pain severity for some patients. This suggests that focusing on behavior and mindset could offer relief for those experiencing ongoing headaches after trauma. ^{1 2 4 6 7}

Who Is on the Research Team?

Joel Fishbein

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for individuals suffering from persistent headaches following a traumatic brain injury. Participants should be experiencing these post-traumatic headaches at the time of enrollment.

Inclusion Criteria

My headache or psychiatric treatment hasn't changed in 3 months and won't change during the study.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 12 weeks

Treatment

Participants receive either Headache Reprocessing Therapy or headache education in group format over eight sessions

8 weeks

8 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for adverse events and satisfaction with the intervention

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Headache education
• Headache reprocessing

Trial Overview The study is examining a new treatment called Headache reprocessing and comparing it to headache education to see which is more effective for treating persistent post-traumatic headaches.

How Is the Trial Designed?

Group I: Headache reprocessing Experimental Treatment 1 Intervention

Behavior therapy focused on sensations and avoidance behaviors

Group II: Headache education Active Control 1 Intervention

Education about ways to limit and manage headaches

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10342432/

Post-Traumatic Headache: A Review of Prevalence, Clinical ... A study of patients with PTH found that 28% had a 50% reduction in days with moderate or severe headache following open-label treatment with erenumab, a CGRP ...

2. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14795

American Headache Society white paper on treatment of post ... Overall, 70% of patients reported at least some improvement in headache, but response to treatment was not stratified by headache type. Until ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.08.11.25332976v1.full-text

Efficacy and Outcomes of Pharmacological Treatments for ... Most studies reported some improvements in headache frequency and intensity, with some also noting benefits in headache burden and QoL. Study ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07229391?lastUpdPost=2020-01-16_

Study Details | NCT07229391 | BT vs Education for PPTH This research seeks to develop a new behavioral treatment, called headache reprocessing, to target fear and avoidance behaviors and cognitions, ...

5. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-018-0943-2

Lifestyle modifications as therapy for medication refractory ... After intervention, there was a 36% decrease in PTHA frequency, 56% decrease in headache severity and 60% of patients had improved quality of ...

6. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-019-1051-7

Acute and preventive pharmacological treatment of post ... We found that there is a lack of high-quality evidence-based studies on the pharmacological treatment of PTH. Future studies are highly needed.

7. now.aapmr.org now.aapmr.org/postconcussion-headache/

Post Traumatic Headache | PM&R KnowledgeNow - AAPM&R Risk factors for acute PTH in adults with moderate or severe TBI include a history of migraine and/or other moderate to severe headache ...