Multisite Advancement of Research on Chronic Posttraumatic Headache

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.

Conditions

• Posttraumatic Headache

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.

Sponsors & Collaborators

• Brooke Army Medical Center

  collaborator FED

• C.R.Darnall Army Medical Center

  collaborator FED

• Desmond Doss Health Clinic, Schofield Barracks

  collaborator UNKNOWN

• Minneapolis Veterans Affairs Medical Center

  collaborator FED

• South Texas Veterans Health Care System

  collaborator FED

• VA Palo Alto Health Care System

  collaborator FED

• Walter Reed National Military Medical Center

  collaborator FED

• Harvard University

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• United States Department of Defense

  collaborator FED

• The University of Texas Health Science Center at San Antonio

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-24

Primary Completion

2026-09-30

Completion

2027-08-31

Countries

• United States

Study Locations