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Multisite Advancement of Research on Chronic Posttraumatic Headache

NCT ID: NCT05620719
Registry status: Recruiting
Study type: Interventional
Phase: Not applicable
Sponsor: The University of Texas Health Science Center at San Antonio
Conditions: Posttraumatic Headache

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache

Enrollment: 525 participants (Estimated).

What is being studied

Intervention: Behavior Therapy
Intervention: Behavioral Disciplines and Activities
Intervention: Cognitive Behavioral Therapy
Behavioral: Cognitive Behavioral Therapy for Posttraumatic Headache
Intervention: Psychotherapy
Other: Telemedicine-based Cognitive Behavioral Therapy (TCBT)
Intervention: Therapeutics
Other: Treatment as Usual

Who may be eligible

Ages: 18 Years to 70 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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.

Study locations

8 study locations are listed.

Recruiting site status is explicitly provided for 8 locations; 5 are listed as Recruiting.

Countries: United States

California, United States: 2
Hawaii, United States: 1
Maryland, United States: 1
Minnesota, United States: 1
Texas, United States: 3

Sample of listed locations

VA Greater Los Angeles Healthcare System — Los Angeles, California, 90073, United States — Recruiting
VA Palo Alto Health Care System — Palo Alto, California, 94304, United States — Recruiting
Carl R. Darnall Army Medical Center (Fort Cavazos) — Killeen, Texas, 76544, United States — Recruiting
Brooke Army Medical Center — San Antonio, Texas, 78234, United States — Recruiting
South Texas Veterans Health Care System — San Antonio, Texas, 78229, United States — Recruiting
Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks) — Honolulu, Hawaii, 96819, United States — Completed
Walter Reed National Military Medical Center — Bethesda, Maryland, 20889, United States — Withdrawn
Minneapolis VA Health Care System — Minneapolis, Minnesota, 55417, United States — Active, not recruiting

Study details

Start date: August 24, 2023
Primary completion date: September 1, 2026
Completion date: August 1, 2027
First posted: November 17, 2022
Collaborators: Brooke Army Medical Center, C.R.Darnall Army Medical Center, Desmond Doss Health Clinic, Schofield Barracks, Harvard University, Minneapolis Veterans Affairs Medical Center, South Texas Veterans Health Care System, United States Department of Defense, University of California, Los Angeles, VA Palo Alto Health Care System, Walter Reed National Military Medical Center

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05620719
Registry last updated: September 22, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT05620719 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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