NCT03932773 Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
| NCT ID | NCT03932773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas at Dallas |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2019-05-01 |
| Primary Completion | 2026-07-31 |
Trial Parameters
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Brief Summary
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
Inclusion Criteria: * Veterans of Post-9/11 military conflicts * with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat Exclusion Criteria: * 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, * brain tumors, * moderate to severe substance use disorder in last 3 months or any substance use that puts the participant at increased risk or significant impairment * stroke, and blood vessel abnormalities in the brain, * dementia, * Parkinson's disease, Huntington's chorea, or multiple sclerosis * a high suicide risk * a lifetime history of psychotic disorder or bipolar disorder * inability to stop taking any medication that significantly lowers the seizure threshold * pregnant or n