Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
VA Greater Los Angeles Healthcare System
NOT_YET_RECRUITING
Los Angeles
VA Palo Alto Health Care System
RECRUITING
Palo Alto
Hawaii
Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)
RECRUITING
Honolulu
Maryland
Walter Reed National Military Medical Center
WITHDRAWN
Bethesda
Minnesota
Minneapolis VA Health Care System
RECRUITING
Minneapolis
Texas
Carl R. Darnall Army Medical Center (Fort Cavazos)
RECRUITING
Killeen
Brooke Army Medical Center
RECRUITING
San Antonio
South Texas Veterans Health Care System
RECRUITING
San Antonio
Contact Information
Primary
Nicole A Brackins, MS
brackins@uthscsa.edu
210-450-8076
Backup
Fermin A Carrizales
carrizalesF@uthscsa.edu
210-562-6724
Time Frame
Start Date: 2023-08-24
Estimated Completion Date: 2026-08
Participants
Target number of participants: 525
Treatments
Active_comparator: Clinic-based Cognitive Behavioral Therapy (CCBT)
CCBT provides CBT for posttraumatic headache through 8 face-to-face, in-clinic sessions.
Active_comparator: Telemedicine-based Cognitive Behavioral Therapy (TCBT)
TCBT provides 8-sessions of CBT for posttraumatic headache using telemedicine technology rather than attending in-office sessions. Additionally, TCBT includes instructions for each session specific to the mechanics of a telehealth encounter (e.g., asking participant for name, location, and accessible phone number for location in case of technical failure or crisis). All TCBT participants must be enrolled at the MTF or VA from which they were recruited, and the treatment facility will be notified that they are receiving TCBT in case a crisis arises and needs to be managed by the site.
Active_comparator: Treatment As Usual
Participants will continue to engage in clinical care as usual for 8 weeks. Research staff will call the TAU participants weekly to assess for adverse events. Research staff at each site will be trained on standardized assessment of usual care activities using forms adapted from our single-site trial.
Related Therapeutic Areas
Sponsors
Collaborators: Brooke Army Medical Center, Desmond Doss Health Clinic, Schofield Barracks, United States Department of Defense, C.R.Darnall Army Medical Center, South Texas Veterans Health Care System, Minneapolis Veterans Affairs Medical Center, Walter Reed National Military Medical Center, University of California, Los Angeles, VA Palo Alto Health Care System, Harvard University
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov