RECRUITING

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

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Conditions

Post Traumatic Stress DisorderPTSDpost-traumatic stress disordermilitary-related PTSDCPTcognitive processing therapyrTMSrepetitive transcranial magnetic stimulationcombatcombat-related PTSD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-05-01
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03932773

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veterans of Post-9/11 military conflicts
  2. * with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat
  1. * current enrollment in an acute experimental treatment for PTSD or trauma-focused psychotherapy treatment
  2. * PTSD-inducing trauma exposure occurring within the last 3 months prior to pre-enrollment evaluation
  3. * history of epilepsy or seizure disorder, a history of major head trauma,
  4. * any neurologic condition likely to increase risk of seizures,
  5. * brain tumors,
  6. * moderate to severe substance use disorder in last 3 months or any substance use that puts the participant at increased risk or significant impairment
  7. * stroke, and blood vessel abnormalities in the brain,
  8. * dementia,
  9. * Parkinson's disease, Huntington's chorea, or multiple sclerosis
  10. * a high suicide risk
  11. * a lifetime history of psychotic disorder or bipolar disorder
  12. * inability to stop taking any medication that significantly lowers the seizure threshold
  13. * pregnant or nursing
  14. * metal fragments in the head, or any metal objects in or near the head that cannot be safely removed
  15. * We will screen for a history of traumatic brain injury and exclude potential participants from the study if they have a history of severe TBI or are at high risk for seizures.
  16. * history of seizures
  17. * non-English speakers because not all of the screening forms, questionnaires, and tests are available in any language except for English
  18. * cardiac pacemaker, implanted medication pumps of any sort that would increase the risk of rTMS
  19. * any current medical condition that could preclude being able to safely participate in TMS treatment,
  20. * use of prescription medication or illegal substances that lower the seizure threshold
  21. * previous rTMS

Contacts and Locations

Study Contact

Elizabeth "Ellen" Morris, PhD
CONTACT
214-883-3171
neurolab@utdallas.edu
Jill Ritter, BS
CONTACT
972-883-3171
neurolab@utdallas.edu

Principal Investigator

John Hart, Jr., MD
PRINCIPAL_INVESTIGATOR
The University of Texas at Dallas
F. Andrew Kozel, MD
PRINCIPAL_INVESTIGATOR
Florida State University, College of Medicine
John Burruss, MD
PRINCIPAL_INVESTIGATOR
Metrocare Services of Dallas

Study Locations (Sites)

Florida State University College of Medicine
Tallahassee, Florida, 32308
United States
Metrocare Services of Dallas
Addison, Texas, 75001
United States
The University of Texas at Dallas
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: The University of Texas at Dallas

  • John Hart, Jr., MD, PRINCIPAL_INVESTIGATOR, The University of Texas at Dallas
  • F. Andrew Kozel, MD, PRINCIPAL_INVESTIGATOR, Florida State University, College of Medicine
  • John Burruss, MD, PRINCIPAL_INVESTIGATOR, Metrocare Services of Dallas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-01
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2019-05-01
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • PTSD
  • post-traumatic stress disorder
  • military-related PTSD
  • CPT
  • cognitive processing therapy
  • rTMS
  • repetitive transcranial magnetic stimulation
  • combat
  • combat-related PTSD

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder