Multisite Advancement of Research on Chronic Posttraumatic Headache
Posttraumatic Headache
About this trial
This is an interventional treatment trial for Posttraumatic Headache focused on measuring Cognitive Behavioral Therapy, Telehealth, Veterans, Military Service Members, Chronic Pain, Headaches
Eligibility Criteria
Inclusion Criteria: Any veteran or active duty service member (age 18 to 70 years) with mTBI whose headache began or exacerbated within 3 months of a head or neck injury. Headache meets ICHD-3 A5.2.2.1 criterion for delayed-onset persistent headache attributable to mild 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; this includes botulinum toxin injections and devices like Cefaly). Participant has a phone were they can receive reminders and complete the on-line Sleep Diaries. To participate in telemedicine study arm, participants must: Have access to high-speed internet or 4G/5G phone service and be able to connect from a location that affords privacy. Have phone or computer equipment to run the virtual video connect platform OR be willing to use study-provided equipment for the duration of the study. Exclusion Criteria: Participant reports a significant change in headache symptoms within 4 weeks of screening or has another secondary headache that may account for symptoms. Participant has medication overuse headache based on Structured Diagnostic Headache Interview-Revised (Brief Version; SDIH-R) and clinical judgment. Participant is unable to read or speak English at a 6th grade level. Participant has a psychiatric problem that warrants immediate treatment as indicated in the electronic health record, flagged study during testing, or confirmed by a clinician through screening or review of clinical notes. Participant demonstrates significant cognitive impairment that could impact treatment adherence/benefit.
Sites / Locations
- South Texas Veterans Health Care SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Clinic-based Cognitive Behavioral Therapy (CCBT)
Telemedicine-based Cognitive Behavioral Therapy (TCBT)
Treatment As Usual
CCBT provides CBT for posttraumatic headache through 8 face-to-face, in-clinic sessions.
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.
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.