Behavior Therapy vs Education for Persistent Headache After Mild TBI (NCT07229391) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Behavior Therapy vs Education for Persistent Headache After Mild TBI
United States60 participantsStarted 2027-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is still listed as 'not yet recruiting' — do you know when it's expected to open and whether it would be worth revisiting once it does?
2Since this study is measuring things like enrollment rates, attendance, and homework completion rather than directly proving which treatment works better, does that mean the main goal is to test whether a larger trial is even feasible, and what would that mean for what my family and I could realistically expect to learn from it?
3The trial compares behavior therapy to education for post-traumatic headache after a mild TBI — given my specific situation and how long I've had symptoms, do you think one of those approaches already has enough evidence to try on its own outside of a trial?
4The study tracks adverse events related to the intervention, which are listed as a primary outcome — what kinds of risks or side effects have been seen with behavior therapy programs for headache in other studies, and is there anything about my health history that might make those risks higher for me?
5The trial uses the Headache Impact Test-6 to measure change in how much headaches affect daily life — based on where I'd likely score on that scale right now, do you think I'd be a meaningful candidate for this kind of study when it does open?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Enrollment rate
Timeframe: Typically up to 3 months, from initial referral to decision to enroll or not