A Randomized Clinical Trial Using Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI
The University of Texas Health Science Center at San Antonio
Summary
In this study, the investigators are evaluating whether transcranial direct current stimulation (tDCS), a brain stimulation technique, can be combined with Written Exposure Therapy (WET), a standard talk therapy for posttraumatic stress disorder (PTSD) to improve treatment response and improve symptom of traumatic brain injury (TBI). After consenting to be in the study, participants will be asked to complete a baseline assessment of your psychological and physical health that will determine whether you are able to participate in the study. Following the baseline, you will be randomly assigned to receive tDCS or a sham/placebo. Everyone will also participate in 5 weekly WET psychotherapy sessions for 5 consecutive weeks. The first appointment will be 90 minutes and the subsequent appointments will be 60 minutes. tDCS or sham/placebo will occur during the writing portion of the session. All participants will also be asked to complete 1-, 3-, and 6-month posttreatment follow-up assessments.
Description
The primary objective of this study is to build upon a previously conducted pilot study and formally test the synergistic effects of tDCS with WET for PTSD in military service members and veterans with TBI. Secondary objectives are to evaluate improvements in persistent PCS of TBI, examine tDCS effects on physiological outcomes of extinction learning, and explore the dynamic timing of PTSD and PCS improvements to better understand how tDCS treatment influences these comorbid conditions. Aim 1: To conduct a 2-arm, double-blind, sham-controlled randomized clinical trial of active tDCS with WET…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. U.S military service member or veteran (18-70 years old) 2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5-R) 3. History of mild to moderate Traumatic Brain Injury (TBI) 4. Able to speak, read, and write in English (due to assessment measures and writing intervention) Exclusion Criteria: 1. TBI that occurred within the past three months prior to the baseline assessment 2. History of significant intracranial pathology (e.g., severe TBI) 3. History of major neurological disorder (e.g., epilepsy, dementia) 4. Metallic objects othe…
Interventions
- DeviceTranscranial Direct Current Stimulator
tDCS will be administered using a Soterix 1x1 Transcranial Direct Current Stimulator. The intervention for this study will compare five, 30 minute sessions of active tDCS (2.0mA) targeting the dorsolateral prefrontal cortex (DLPFC) vs. a sham condition (0.0mA) for the treatment of PTSD in a sample of military personnel with mild to moderate TBI.
- OtherWritten Exposure Therapy
Participants in both treatment conditions will receive 5 weekly sessions of WET delivered as standard of care for PTSD. WET is an evidence-based, trauma-focused therapy for PTSD that is recommended by the VA/DoD Clinical Practice Guidelines for PTSD that is brief and effective.
Location
- The University of Texas Health Science Center at San AntonioSan Antonio, Texas