Comparing telehealth and in-person therapy for chronic headaches in veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• VA Greater Los Angeles Healthcare System
  Los Angeles, California, United States Recruiting
• VA Palo Alto Health Care System
  Palo Alto, California, 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
• Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)
  Honolulu, Hawaii, United States Completed

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using Botox to treat posttraumatic headaches

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  Recruiting at 2 sites Phase 2 Northwestern University · Chicago, Illinois and 2 other locations · NCT06608277

• Using a medication to treat headaches after mild brain injuries in military and civilian patients

  This study is testing if a new medication can help people with mild brain injuries and headaches feel better compared to a placebo.

  Recruiting at 2 sites Phase 2 Henry M. Jackson Foundation for the Advancement of Military Medicine · Fort Bragg, North Carolina and 3 other locations · NCT05049057

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.