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

NARecruitingINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

May 1, 2019

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Post Traumatic Stress Disorder
Interventions
DEVICE

Active rTMS

"A Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be used to deliver 1 hertz (Hz) stimulation to right dorsolateral prefrontal cortex (rDLPFC) at 110% of a participant's rTMS motor threshold. The device passes electric current through a coil generating an alternating magnetic field. When positioned over the skull, the changing magnetic field causes electromagnetic inducted current flow in brain regions subjacent to the coil. Magnetic pulses (1.5-2.0 Tesla) lasting 100-300 microseconds at 1 Hz will be used.~Motor threshold will be defined by the TMS intensity to right motor region required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time."

DEVICE

Sham rTMS

"A Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be paired with sham coil. The sham coil will induce electrical current flow in the tissue above the skull but will not induce current flow in brain tissue. The sham coil will be placed over the right prefrontal scalp region to target current flow in rDLPFC. Magnetic pulses lasting for 100-300 microseconds at 1 Hz will be used.~For consistency across the rTMS conditions, motor threshold in the sham condition also will be determined by positioning the active rTMS coil over the right motor region and identifying the stimulation intensity required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time."

BEHAVIORAL

Cognitive Processing Therapy

Cognitive Processing Therapy (CPT) is an evidenced based, trauma-focused treatment for Posttraumatic Stress Disorder (PTSD). CPT is a recommended form of treatment in the Veterans Administration - Department of Defense Clinical Practice Guideline for PTSD. The CPT manual delineates the agenda for each of 12 sessions (60 minutes per session): 1) Introduction to CPT and Patient Education regarding PTSD, 2) Meaning of the Trauma, 3) Identification of Thoughts and Feelings related to the Trauma, 4) Remembering the Trauma, 5) Identification of Stuck points, 6) Challenging Questions about the Trauma, 7) Dysfunctional/Maladaptive Thinking patterns related to the Trauma, 8) Safety Issues, 9) Trust Issues, 10) Power and Control Issues, 11) Self-Esteem Issues, and 12) Intimacy Issues.

Trial Locations (3)

32308

RECRUITING

Florida State University College of Medicine, Tallahassee

75001

RECRUITING

Metrocare Services of Dallas, Addison

75235

RECRUITING

The University of Texas at Dallas, Dallas

All Listed Sponsors
collaborator

University of Texas Southwestern Medical Center

OTHER

collaborator

Johns Hopkins University

OTHER

collaborator

Metrocare Services of Dallas

UNKNOWN

collaborator

Florida State University

OTHER

lead

The University of Texas at Dallas

OTHER