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

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
The University of Texas at Dallas
Study ID
NCT03932773
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Active rTMS — DEVICE
    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.
  • Sham rTMS — DEVICE
    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.
  • Cognitive Processing Therapy — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 1, 2019
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sham rTMS + CPT
    30 minutes of sham repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) prior to each Cognitive Processing Therapy (CPT) session
  • Active Comparator: Active rTMS + CPT
    30 minutes of 1 Hz rTMS to rDLPFC prior to each CPT session
  • Active Comparator: Active rTMS Alone
    30 minutes of 1 Hz rTMS to rDLPFC at 1 session per week over 12 weeks

Primary Outcome Measure

Treatment group differences in change from baseline to 6-months post-treatment on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score [ Time Frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Florida State University College of MedicineTallahasseeFlorida32308
FSU Neuromodulation
[email protected]
850-644-2824
Metrocare Services of DallasAddisonTexas75001
Steven A Cohen Military Family Clinic at Metrocare
[email protected]
469-680-3500
The University of Texas at DallasDallasTexas75235
Celia Higginbotham
[email protected]
972-883-3171
Crista Thyvelikakath, MA
[email protected]
972-883-3171
Michael Motes, PhD (SUB_INVESTIGATOR)
Gail Tillman, PhD (SUB_INVESTIGATOR)

Find similar trials in Tallahassee, FL

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Florida State University College of Medicine· Tallahassee, FLMetrocare Services of Dallas· Addison, TXThe University of Texas at Dallas· Dallas, TX

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