NCT05620719 Multisite Advancement of Research on Chronic Posttraumatic Headache
| NCT ID | NCT05620719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Posttraumatic Headache |
| Study Type | INTERVENTIONAL |
| Enrollment | 525 participants |
| Start Date | 2023-08-24 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 525 participants in total. It began in 2023-08-24 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 confirmed by a clinician through screening or review of clinical notes. * Participant demonstrates significant cognitive impairment that could impact treatment adherence/benefit.
Contact & Investigator
Donald D McGeary, PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT05620719 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Posttraumatic Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05620719 currently recruiting?
Yes, NCT05620719 is actively recruiting participants. Contact the research team at brackins@uthscsa.edu for enrollment information.
Where is the NCT05620719 trial being conducted?
This trial is being conducted at Los Angeles, United States, Palo Alto, United States, Honolulu, United States, Bethesda, United States and 4 additional locations.
Who is sponsoring the NCT05620719 clinical trial?
NCT05620719 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Donald D McGeary, PhD at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 525 participants.