Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe University of Texas at Dallas

About this trial

The purpose of this study is to examine the benefits of combining repetitive Transcranial Magnetic Stimulation (rTMS) coupled with Cognitive Processing Therapy (CPT) in treating combat-related Posttraumatic Stress Disorder (PTSD) symptoms. The study will also examine change in depression, psychosocial functioning, and neurophysiological (i.e., electroencephalography and magnetic resonance images) measures.

Eligibility criteria

Qualifiers

Veterans of Post-9/11 military conflicts

with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat

Disqualifiers

current enrollment in an acute experimental treatment for PTSD or trauma-focused psychotherapy treatment

PTSD-inducing trauma exposure occurring within the last 3 months prior to pre-enrollment evaluation

history of epilepsy or seizure disorder, a history of major head trauma,

any neurologic condition likely to increase risk of seizures,

Trial design

Treatments tested in this trial

  • Active rTMS
  • Sham rTMS
  • Cognitive Processing Therapy

Treatment groups

330 Participants
are divided into 3 treatment groups

Sponsors and collaborators

The University of Texas at Dallas

Lead sponsor

University of Texas Southwestern Medical Center

Collaborator

Johns Hopkins University

Collaborator

Metrocare Services of Dallas

Collaborator

Florida State University

Collaborator