Comparing telehealth and in-person therapy for chronic headaches in veterans
Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache
NA · The University of Texas Health Science Center at San Antonio · NCT05620719
This study is testing if therapy for chronic headaches delivered through telehealth is just as helpful as in-person therapy for veterans and active duty service members.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 525 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio (other) |
| Locations | 8 sites (Los Angeles, California and 7 other locations) |
| Trial ID | NCT05620719 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Cognitive Behavioral Therapy (CBT) for chronic posttraumatic headache (PTH) delivered through telemedicine compared to traditional in-person therapy and standard treatment. It involves 525 veterans and active duty service members with chronic PTH, assessing their headache-related disability and psychiatric comorbidities across multiple VA medical centers and military treatment facilities. The study will compare outcomes from Clinic-based Cognitive Behavioral Therapy (CCBT), Telemedicine-based Cognitive Behavioral Therapy (TCBT), and Treatment as Usual (TAU). The goal is to determine if telehealth can provide similar benefits as in-person therapy for this population.
Who should consider this trial
Good fit: Ideal candidates include veterans or active duty service members aged 18 to 70 with mild to moderate traumatic brain injury and chronic posttraumatic headaches.
Not a fit: Patients with severe headache-related disability or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance access to effective headache treatment for veterans and service members, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown that in-person CBT significantly improves outcomes for veterans with PTH, but the effectiveness of telehealth approaches remains to be established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California and 7 other locations
- VA Greater Los Angeles Healthcare System — Los Angeles, California, United States (RECRUITING)
- VA Palo Alto Health Care System — Palo Alto, California, United States (RECRUITING)
- Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks) — Honolulu, Hawaii, United States (RECRUITING)
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (WITHDRAWN)
- Minneapolis VA Health Care System — Minneapolis, Minnesota, United States (RECRUITING)
- Carl R. Darnall Army Medical Center (Fort Cavazos) — Killeen, Texas, United States (RECRUITING)
- South Texas Veterans Health Care System — San Antonio, Texas, United States (RECRUITING)
- Brooke Army Medical Center — San Antonio, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Donald D McGeary, PhD — The University of Texas Health Science Center at San Antonio
- Study coordinator: Nicole A Brackins, MS
- Email: brackins@uthscsa.edu
- Phone: 210-450-8076
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Posttraumatic Headache, Cognitive Behavioral Therapy, Telehealth, Veterans, Military Service Members, Chronic Pain, Headaches