Multisite Advancement of Research on Chronic Posttraumatic Headache

Description

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.

Conditions

Posttraumatic Headache

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Study Overview

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Study Details

Study overview

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.

Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache

Multisite Advancement of Research on Chronic Posttraumatic Headache

Condition
Posttraumatic Headache
Intervention / Treatment

-

Contacts and Locations

Los Angeles

VA Greater Los Angeles Healthcare System, Los Angeles, California, United States, 90073

Palo Alto

VA Palo Alto Health Care System, Palo Alto, California, United States, 94304

Honolulu

Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks), Honolulu, Hawaii, United States, 96819

Bethesda

Walter Reed National Military Medical Center, Bethesda, Maryland, United States, 20889

Minneapolis

Minneapolis VA Health Care System, Minneapolis, Minnesota, United States, 55417

Killeen

Carl R. Darnall Army Medical Center (Fort Cavazos), Killeen, Texas, United States, 76544

San Antonio

South Texas Veterans Health Care System, San Antonio, Texas, United States, 78229

San Antonio

Brooke Army Medical Center, San Antonio, Texas, United States, 78234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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; 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.
  • * 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center at San Antonio,

Donald D McGeary, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

2026-08