Multisite Advancement of Research on Chronic Posttraumatic Headache
RecruitingNot applicableNCT05620719
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache
- Conditions
- Posttraumatic Headache
- Interventions
- Behavioral: Cognitive Behavioral Therapy for Posttraumatic Headache
- Other: Treatment as Usual
- Other: Telemedicine-based Cognitive Behavioral Therapy (TCBT)
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Collaborators
- Brooke Army Medical Center; C.R.Darnall Army Medical Center; Desmond Doss Health Clinic, Schofield Barracks; Minneapolis Veterans Affairs Medical Center; South Texas Veterans Health Care System; VA Palo Alto Health Care System; Walter Reed National Military Medical Center; Harvard University; University of California, Los Angeles; United States Department of Defense
- Start date
- 2023-08-24
- Primary completion
- 2026-09
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 8
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 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. 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 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05620719