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RECRUITING
NCT05620719
NA

Multisite Advancement of Research on Chronic Posttraumatic Headache

Sponsor: The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

525

Start Date

2023-08-24

Completion Date

2027-08

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Posttraumatic Headache

CBT for Posttraumatic Headaches consists of 8 sessions of cognitive behavioral therapy that focus on (1) discussions and exercises that increase awareness of what may be related to headaches, (2) relaxation techniques to manage physiological stress, and (3) problem-solving techniques to manage common stressors. Sessions are delivered weekly and can last between 45 to 75 minutes based on clinical content and patient response to the material.

OTHER

Treatment as Usual

Participants will continue to engage in medical care as usual for 8 weeks.

OTHER

Telemedicine-based Cognitive Behavioral Therapy (TCBT)

Participants assigned to TCBT will receive 8 sessions of cognitive behavioral therapy using telemedicine rather than face-to face office visits.

Locations (8)

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)

Honolulu, Hawaii, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Minneapolis VA Health Care System

Minneapolis, Minnesota, United States

Carl R. Darnall Army Medical Center (Fort Cavazos)

Killeen, Texas, United States

South Texas Veterans Health Care System

San Antonio, Texas, United States

Brooke Army Medical Center

San Antonio, Texas, United States