What this study is
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.
What's being tested
- Cognitive Behavioral Therapy for Posttraumatic Headache
Intervention · BEHAVIORAL
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.
- Treatment as Usual
Intervention · OTHER
Participants will continue to engage in medical care as usual for 8 weeks.
- Telemedicine-based Cognitive Behavioral Therapy (TCBT)
Intervention · OTHER
Participants assigned to TCBT will receive 8 sessions of cognitive behavioral therapy using telemedicine rather than face-to face office visits.
Study details
- Official title
- Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Conditions
- Posttraumatic Headache
- Enrolling
- 525 people
- Starts
- 2023-08-24
- Est. completion
- 2027-08
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (8)
5 openVA Greater Los Angeles Healthcare System
Los Angeles, California, United States
- Rocio Vallejo · Contact310-478-3711 ext. 42647rocio.vallejo@va.gov
- Revati Mummaneni, MD · Principal investigator
RecruitingVA Palo Alto Health Care System
Palo Alto, California, United States
- Marisol Duran, MA · Contact650-493-5000 ext. 62846marisol.duran@va.gov
- Molly Timmerman, DO · Principal investigator
RecruitingCarl R. Darnall Army Medical Center (Fort Cavazos)
Killeen, Texas, United States
- Paul Fowler · Contact254-288-1638Fowlerp@UTHSCSA.edu
- Scot Engel, PsyD · Principal investigator
RecruitingSouth Texas Veterans Health Care System
San Antonio, Texas, United States
- Alex Carrizales · Contact210-617-5300 ext. 114539carrizalesf@uthscsa.edu
- Ashley Lujan, DO · Principal investigator
RecruitingBrooke Army Medical Center
San Antonio, Texas, United States
- Moraima Rodriguez Guerrero · Contact210-562-6709rodriguezgue@uthscsa.edu
- Alexis Nelson, MD · Principal investigator
RecruitingTripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)
Honolulu, Hawaii, United States
CompletedWalter Reed National Military Medical Center
Bethesda, Maryland, United States
WithdrawnMinneapolis VA Health Care System
Minneapolis, Minnesota, United States
Active, not recruiting
Study team
Sponsor
The University of Texas Health Science Center at San Antonio
Study ID HSC20220592H
Principal investigator
Donald D McGeary, PhD
The University of Texas Health Science Center at San Antonio
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.