Can a phone call ease warzone headaches? new trial tests virtual therapy for veterans
NCT ID NCT05620719
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether cognitive behavioral therapy (CBT) delivered via telemedicine can reduce headache-related disability in 525 veterans and service members with chronic posttraumatic headache after a mild or moderate brain injury. Participants will be randomly assigned to in-person CBT, telemedicine CBT, or usual care. The goal is to see if virtual therapy works as well as in-person sessions, potentially expanding access to care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognitive Behavioral Therapy (CBT)
- What this could lead to
- If successful, this could show that telemedicine-based CBT is as effective as in-person therapy, making it easier for veterans to access care for chronic headaches.
- What could go wrong
- This is a behavioral intervention study, not a drug trial, so benefits may be modest. The results depend on participant engagement, and telemedicine may not work as well for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 525 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brooke Army Medical Center
RECRUITINGSan Antonio, Texas, 78234, United States
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Carl R. Darnall Army Medical Center (Fort Cavazos)
RECRUITINGKilleen, Texas, 76544, United States
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Minneapolis VA Health Care System
RECRUITINGMinneapolis, Minnesota, 55417, United States
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South Texas Veterans Health Care System
RECRUITINGSan Antonio, Texas, 78229, United States
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Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)
ACTIVE_NOT_RECRUITINGHonolulu, Hawaii, 96819, United States
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VA Greater Los Angeles Healthcare System
RECRUITINGLos Angeles, California, 90073, United States
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VA Palo Alto Health Care System
RECRUITINGPalo Alto, California, 94304, United States
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Walter Reed National Military Medical Center
WITHDRAWNBethesda, Maryland, 20889, United States
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