Actively Recruiting
Multisite Advancement of Research on Chronic Posttraumatic Headache
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-01-20
525
Participants Needed
8
Research Sites
205 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
B
Brooke Army Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multisite Advancement of Research on Chronic Posttraumatic Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veteran or active duty service member aged 18 to 70 years eligible for DEERS
- History of mild or moderate traumatic brain injury with headache beginning or worsening within 3 months of head or neck injury
- Headache meets criteria for delayed-onset persistent headache related to mild or moderate TBI
- Headache ongoing at enrollment with most recent headache within the past 2 weeks
- Moderate to severe headache-related disability with HIT-6 score greater than 50
- Stable on headache medication for at least 4 weeks before baseline or confirmed stable by study physician
- Has a phone to receive reminders and complete online headache diaries
- Able to speak and read English well enough to participate and complete assessments
You will not qualify if you...
- Significant change in headache symptoms within 4 weeks before screening or another secondary headache causing symptoms
- Medication overuse headache based on diagnostic interview and clinical judgment
- Psychiatric problem requiring immediate treatment or identified through clinical records or screening
- Significant cognitive impairment that could affect ability to follow treatment or benefit from it
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Actively Recruiting
2
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Actively Recruiting
3
Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)
Honolulu, Hawaii, United States, 96819
Actively Recruiting
4
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Withdrawn
5
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
6
Carl R. Darnall Army Medical Center (Fort Cavazos)
Killeen, Texas, United States, 76544
Actively Recruiting
7
South Texas Veterans Health Care System
San Antonio, Texas, United States, 78229
Actively Recruiting
8
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
Actively Recruiting
Research Team
N
Nicole A Brackins, MS
CONTACT
F
Fermin A Carrizales
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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