Multisite Advancement of Research on Chronic Posttraumatic Headache

Recruiting now · Not applicable

Conditions studied: Posttraumatic Headache

In brief

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.

Key facts

Study ID

NCT05620719

Run by

The University of Texas Health Science Center at San Antonio

People needed

525

Starts

2023-08-24

Expected to finish

2027-08-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Brooke Army Medical Center — San Antonio, Texas, United States (enrolling)
• VA Palo Alto Health Care System — Palo Alto, California, United States (enrolling)
• South Texas Veterans Health Care System — San Antonio, Texas, United States (enrolling)
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States (enrolling)
• Minneapolis VA Health Care System — Minneapolis, Minnesota, United States (enrolling)
• Carl R. Darnall Army Medical Center (Fort Cavazos) — Killeen, Texas, United States (enrolling)
• Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks) — Honolulu, Hawaii, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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