Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache
The University of Texas Health Science Center at San Antonio
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.
Description
Posttraumatic headache (PTH) is noticeably more common among military service members and veterans than among civilians, with an estimated 80-90% of veterans with TBI reporting new or exacerbated headaches. Unlike civilian PTH, military and veteran PTH is likely to become chronic and recalcitrant to most front-line interventions for primary headache (e.g., migraine, tension-type). Service members and veterans with PTH report significantly decreased productivity in work and home activities and high rates of military discharge and work absenteeism. Pharmacological treatments for chronic PTH have…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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…
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 SystemLos Angeles, California
- VA Palo Alto Health Care SystemPalo Alto, California
- Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)Honolulu, Hawaii
- Walter Reed National Military Medical CenterBethesda, Maryland
- Minneapolis VA Health Care SystemMinneapolis, Minnesota
- Carl R. Darnall Army Medical Center (Fort Cavazos)Killeen, Texas