Post Traumatic Stress DisorderNCT07715799
Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI
A study testing Transcranial Direct Current Stimulator and Written Exposure Therapy in people with Post Traumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Transcranial Direct Current Stimulator and Written Exposure Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- U.S military service member or veteran (18-70 years old)
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5-R)
- History of mild to moderate Traumatic Brain Injury (TBI)
- Able to speak, read, and write in English (due to assessment measures and writing intervention)
Who cannot join
- TBI that occurred within the past three months prior to the baseline assessment
- History of significant intracranial pathology (e.g., severe TBI)
- History of major neurological disorder (e.g., epilepsy, dementia)
- Metallic objects other than dental appliances/fillings above the shoulders.
- Electronic implants that could be susceptible to electrical current (e.g., cardiac pacemaker)
- History of skin condition at site of stimulation (e.g., psoriasis)
Show all 13Show fewer
- Current suicidal ideation severe enough to warrant immediate attention
- Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization
- Current substance use requiring stabilization or hospitalization
- Change in anti-convulsive or benzodiazepine medication regimen in past month.
- History of adverse effects to previous noninvasive brain stimulation.
- Concurrent engagement in another noninvasive brain stimulation or trauma focused psychotherapy.
- Currently pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Randomized Clinical Trial Using Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Transcranial Direct Current Stimulator, Written Exposure Therapy
- Keywords
- PTSD, Transcranial Direct Current Stimulation (tDCS), Written Exposure Therapy (WET)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulatorDevice
Also called tDCS
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.
Written Exposure TherapyOther
Also called WET
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS plus WET treatment | Experimental | Combined use of transcranial direct current stimulation (tDCS) and Written Exposure Therapy (WET) once per week over 5 weeks Receives: Device: Transcranial Direct Current Stimulator; Other: Written Exposure Therapy |
| Sham plus WET | Sham comparator | Sham tDCS plus WET treatment once per week over 5 weeks Receives: Other: Written Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS-5)
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.
Measured: Baseline to 6 months
Neurobehavioral Symptom Inventory (NSI)
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
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 May 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm, double-blind, randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Casey Straud, The University of Texas Health Science Center at San Antonio
- Investigators
- Casey Straud, PsyD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715799
- Sponsor's protocol ID
- STUDY00002715
- Other IDs
- HT9425-25-1-0730
- Status last verified
- Jun 2026
- First submitted
- 16 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A Repository has been approved by UT Health San Antonio IRB to enable storage of data for future use. The Repository is a large comprehensive database of information, biological specimens and neuroimages related to the identification, assessment, and treatment of insomnia, posttraumatic stress disorder (PTSD), and other related behavioral health conditions. Study databases are established and maintained by the STRONG STAR Data Core Services. A unique, sequential numeric STRONG STAR ID will be assigned to each participant at the time of recruitment into this study. However, all Repository data will be identified with a different code number that can be cross linked to the original study code only through records maintained by the STRONG STAR Data Core Services. For participants who decline participation in the STRONG STAR Repository, their data will be de-identified and the data maintained in the Repository without identifiers at the conclusion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Using Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI
- ClinicalTrials.gov ID
- NCT07715799
- Acronym / sponsor ID
- STUDY00002715
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, Transcranial Direct Current Stimulation (tDCS), Written Exposure Therapy (WET)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 May 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm, double-blind, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| tDCS plus WET treatment | Experimental | Device: Transcranial Direct Current Stimulator, Other: Written Exposure TherapyCombined use of transcranial direct current stimulation (tDCS) and Written Exposure Therapy (WET) once per week over 5 weeks |
| Sham plus WET | Sham comparator | Other: Written Exposure TherapySham tDCS plus WET treatment once per week over 5 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- U.S military service member or veteran (18-70 years old)
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5-R)
- History of mild to moderate Traumatic Brain Injury (TBI)
- Able to speak, read, and write in English (due to assessment measures and writing intervention)
Key exclusion criteria (13 listed)
- TBI that occurred within the past three months prior to the baseline assessment
- History of significant intracranial pathology (e.g., severe TBI)
- History of major neurological disorder (e.g., epilepsy, dementia)
- Metallic objects other than dental appliances/fillings above the shoulders.
- Electronic implants that could be susceptible to electrical current (e.g., cardiac pacemaker)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulatorAlso: tDCStDCS 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. | Device | tDCS plus WET treatment |
| Written Exposure TherapyAlso: WETParticipants 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. | Other | Sham plus WET, tDCS plus WET treatment |
Primary outcome
Clinician Administered PTSD Scale (CAPS-5)
Time frame: 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)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Please follow the link to learn more about this study and ongoing STRONG STAR trialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. A Repository has been approved by UT Health San Antonio IRB to enable storage of data for future use. The Repository is a large comprehensive database of information, biological specimens and neuroimages related to the identification, assessment, and treatment of insomnia, posttraumatic stress disorder (PTSD), and other related behavioral health conditions. Study databases are established and maintained by the STRONG STAR Data Core Services. A unique, sequential numeric STRONG STAR ID will be assigned to each participant at the time of recruitment into this study. However, all Repository data will be identified with a different code number that can be cross linked to the original study code only through records maintained by the STRONG STAR Data Core Services. For participants who decline participation in the STRONG STAR Repository, their data will be de-identified and the data maintained in the Repository without identifiers at the conclusion of the study.
Related trials for Post Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Casey Straud, PsyD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulator and Written Exposure Therapy in people with Post Traumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Casey Straud, PsyD (210-562-6742, straud@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS-5) (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.