Multisite Advancement of Research on Chronic Posttraumatic Headache (NCT05620719) | Clinical Trial Compass
RecruitingNot Applicable
Multisite Advancement of Research on Chronic Posttraumatic Headache
United States525 participantsStarted 2023-08-24
Plain-language summary
Posttraumatic headache (PTH) is a common and highly disabling consequence of traumatic brain injury (TBI) in U.S. military service members and veterans. Cognitive Behavioral Therapy for PTH has been shown to significantly improve disability outcomes in veterans with persistent PTH when delivered in-person. Telemedicine platforms can dramatically increase access to evidence-based care. However, whether CBT for PTH retains its effectiveness when delivered through a telemedicine platform has yet to be established. The purpose of this 3-arm randomized clinical trial is to compare Clinic-based Cognitive-Behavioral Therapy (CCBT) to Telemedicine-based Cognitive Behavioral Therapy (TCBT) and to treatment as usual (TAU) in 525 service members and veterans with chronic posttraumatic headaches (PTH) at 4 VA medical centers\* and 3 military treatment facilities across the U.S. Participants will be assessed for headache-related disability, headache experience, and psychiatric comorbidities across multiple time points.
\*VA Palo Alto Health Care System is temporarily randomizing into TAU and TCBT only.
Who can participate
Age range
18 Years – 70 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:
* Any veteran or active duty service member (DEERS-eligible; age 18 to 70 years) with mild or moderate TBI whose headache began or exacerbated within 3 months of a head or neck injury.
* Headache meets ICHD-3 A5.2 criterion for delayed-onset persistent headache attributable to mild or moderate TBI and PTH is ongoing at enrollment (most recent headache within the past 2 weeks).
* At least moderate to severe headache-related disability based on a HIT-6 score greater than 50.
* Participant is stable on headache medication at baseline assessment (i.e., no changes in medication prescriptions in the past 4 weeks or study physician clinical judgement confirms stability; this includes botulinum toxin injections and devices like Cefaly).
* Participant has a phone where they can receive reminders and complete the on-line Headache Diaries.
* Participant speaks and reads/understands English well enough to fully participate in the intervention and to reliably complete assessment measures.
Exclusion Criteria:
* Participant reports a significant change in headache symptoms within 4 weeks of screening or has another secondary headache that may account for symptoms.
* Participant has medication overuse headache based on Structured Diagnostic Headache Interview-Revised (Brief Version; SDIH-R) and clinical judgment.
* Participant has a psychiatric problem that warrants immediate treatment as indicated in the electronic health record, flagged study during testing, or confi…
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 focused on chronic posttraumatic headache — does my specific headache history after my injury fit what this study is looking for, and would it make sense for me to be evaluated for it?
2The trial is measuring change using something called the Headache Impact Test, or HIT-6 — can you help me understand what that means in practice, and whether the way my headaches affect my daily life lines up with what they're trying to study?
3Since this is listed as a multisite study with no assigned phase, it sounds more like a research or observation study than a treatment trial — can you clarify whether participants would actually receive a new treatment, or would I mainly be contributing data about my condition?
4This trial is still actively recruiting — given where I am in my own treatment right now, would joining a study like this interfere with or delay any standard care options I should be considering for my posttraumatic headaches?
5Are there other treatment approaches or specialists you'd recommend I explore first before considering a research study, especially since my headache condition may still be evolving after my injury?
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
Change in Headache Impact Test (HIT-6)
Timeframe: Baseline to 3-month follow-up
Trial details
NCT IDNCT05620719
SponsorThe University of Texas Health Science Center at San Antonio