Post Traumatic Stress Disorder
Conditions
Keywords
PTSD, Transcranial Direct Current Stimulation (tDCS), Written Exposure Therapy (WET)
Brief 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.
Detailed 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 vs. sham tDCS with WET for PTSD in military service members and veterans with TBI (N = 150). Aim 2: To evaluate physiological outcomes during the writing exposure portion of WET as potential mechanisms of change in the treatment of PTSD.
Interventions
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.
Sponsors
The University of Texas Health Science Center at San Antonio
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
tDCS dosing will be double-blind so that none of the participants, investigators, and study staff (including study coordinators, research assistants, assessors, clinicians, clinical supervisors) who interact with participants will know the randomized condition. Only team member(s) who manage randomization will know the randomized dose condition.
Intervention model description
Two arm, double-blind, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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 other than dental appliances/fillings above the shoulders. 5. Electronic implants that could be susceptible to electrical current (e.g., cardiac pacemaker) 6. History of skin condition at site of stimulation (e.g., psoriasis) 7. Current suicidal ideation severe enough to warrant immediate attention 8. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization 9. Current substance use requiring stabilization or hospitalization 10. Change in anti-convulsive or benzodiazepine medication regimen in past month. 11. History of adverse effects to previous noninvasive brain stimulation. 12. Concurrent engagement in another noninvasive brain stimulation or trauma focused psychotherapy. 13. Currently pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS-5) | Baseline to 6 months | The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders v5 (DSM-5) criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms.Subscale scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and mood, and hyperarousal. Scores ≥ 25 indicate a probable diagnosis of PTSD. Scores range from 0 to 80. Change in score will be reported. |
| Neurobehavioral Symptom Inventory (NSI) | Baseline to 6 months | The NSI consists of 22 non-specific complaints commonly reported after concussion and is used by clinicians to quantify TBI symptom severity and select symptoms for treatment. The NSI asks the patient to rate each of the symptoms according to how much the symptom has disturbed him/her using a five-point scale. Scores range from 0-88 with a higher score indicating more neurobehavioral symptoms |
Countries
United States
Contacts
CONTACTCasey Straud, PsyD
CONTACTAmanda Flores, BS
PRINCIPAL_INVESTIGATORCasey Straud, PsyD
The University of Texas Health Science Center at San Antonio
Outcome results
None listed