Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT05620719

Conditions

Posttraumatic Headache

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy for Posttraumatic Headache

Treatment as Usual

Telemedicine-based Cognitive Behavioral Therapy (TCBT)

Study Details

Brief summary:

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.

Conditions

Posttraumatic Headache

Study ID

NCT05620719

Start date

Aug 24, 2023

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

525 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Clinic-based Cognitive Behavioral Therapy (CCBT)

CCBT provides CBT for posttraumatic headache through 8 face-to-face, in-clinic sessions.

active comparator: Telemedicine-based Cognitive Behavioral Therapy (TCBT)

TCBT provides 8-sessions of CBT for posttraumatic headache using telemedicine technology rather than attending in-office sessions. Additionally, TCBT includes instructions for each session specific to the mechanics of a telehealth encounter (e.g., asking participant for name, location, and accessible phone number for location in case of technical failure or crisis). All TCBT participants must be enrolled at the MTF or VA from which they were recruited, and the treatment facility will be notified that they are receiving TCBT in case a crisis arises and needs to be managed by the site.

active comparator: Treatment As Usual

Participants will continue to engage in clinical care as usual for 8 weeks. Research staff will call the TAU participants weekly to assess for adverse events. Research staff at each site will be trained on standardized assessment of usual care activities using forms adapted from our single-site trial.

Interventions

Cognitive Behavioral Therapy for Posttraumatic Headache

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

Participants will continue to engage in medical care as usual for 8 weeks.

Telemedicine-based Cognitive Behavioral Therapy (TCBT)

Participants assigned to TCBT will receive 8 sessions of cognitive behavioral therapy using telemedicine rather than face-to face office visits.

Primary outcome measure

  • Change in Headache Impact Test (HIT-6) [ Time Frame: Baseline to 3-month follow-up ]

Central Contacts and Locations

Central contacts

Nicole A Brackins, MS

210-450-8076brackins@uthscsa.edu

Fermin A Carrizales

210-562-6724carrizalesF@uthscsa.edu

Locations

VA Greater Los Angeles Healthcare System

Recruiting

Los Angeles, California, United States, 90073

Contacts

Rocio Vallejo

310-478-3711rocio.vallejo@va.gov

Principal Investigator:

Revati Mummaneni, MD

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Marisol Duran, MA

650-493-5000marisol.duran@va.gov

Principal Investigator:

Molly Timmerman, DO

Minneapolis VA Health Care System

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Chay'La Hart

612-467-2924Chay'La.Hart@va.gov

Principal Investigator:

Rebecca Vogsland, DPT

Carl R. Darnall Army Medical Center (Fort Cavazos)

Recruiting

Killeen, Texas, United States, 76544

Contacts

Paul Fowler

254-288-1638Fowlerp@UTHSCSA.edu

Principal Investigator:

Scot Engel, PsyD

South Texas Veterans Health Care System

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Alex Carrizales

210-617-5300carrizalesf@uthscsa.edu

Principal Investigator:

Ashley Lujan, DO

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Moraima Rodriguez Guerrero

210-562-6709rodriguezgue@uthscsa.edu

Principal Investigator:

Alexis Nelson, MD

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Cognitive Behavioral Therapy
  • Telehealth
  • Veterans
  • Military Service Members
  • Chronic Pain
  • Headaches

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-06-26.