RecruitingNot ApplicableNCT05620719

Multisite Advancement of Research on Chronic Posttraumatic Headache

Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

525 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cognitive Behavioral Therapy for Posttraumatic Headache, Telemedicine-based Cognitive Behavioral Therapy (TCBT), and others for people with posttraumatic headache. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive 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.

OTHERTreatment as Usual

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

OTHERTelemedicine-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

View Full Details on ClinicalTrials.gov

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NCT05620719


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