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The primary objective of this study is to evaluate the safety, feasibility, and psychological and physiological treatment benefits of transcranial direct current stimulation (tDCS), a noninvasive brain stimulation technique, when delivered in combination with Written Exposure Therapy (WET), for posttraumatic stress disorder posttraumatic stress disorder (PTSD).
While the potential for non-invasive brain stimulation is exciting, research is needed to determine the safety, feasibility, and benefits of non-invasive brain stimulation in human subjects with PTSD. Towards this end, the study team will conduct a single-blind randomized controlled pilot study of transcranial direct current stimulation (tDCS) vs. a sham condition in a sample of 40 adults with PTSD receiving 5 weekly sessions of Written Exposure Therapy (WET), an exposure-based, behavioral psychotherapy for PTSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS plus WET | Experimental | Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET) |
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| Sham plus WET | Sham Comparator | Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soterix 1x1 tDCS mini CT | Device | During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize. |
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic Stress Disorder Checklist (PCL-5) | The PCL-5 is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 is currently available and has been shown to have good psychometric properties. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). This measure will be administered at the baseline assessment, prior to each therapy session, and the one-month follow-up assessment. The potential scores range from 0-80, with a lower score indicating less symptoms of PTSD. | Baseline to 9 weeks (one month post study treatment) |
| Number of Subjects That Completed All 5 WET Sessions | Tracking feasibility through number of subjects that complete all written exposure therapy | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administer PTSD Scale-5 (CAPS-5) | The CAPS-5 is structured interview that assesses the 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. Additional items that are not included in the total score evaluate overall symptom duration, distress, impairment, dissociative symptoms, and global ratings by the interviewer. Scores range from 0-80, with lower scores indicating less PTSD severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Casey Straud, PsyD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
At the conclusion of this study, participants who signed the consent to have their data placed in the STRONG STAR Repository will be maintained under the UTHSCSA IRB-approved Repository protocol. For participants who decline participation in the STRONG STAR Repository, at the conclusion of the study their data will be de-identified and the data maintained in the Repository without identifiers. The IRB approved STRONG STAR Repository is a large comprehensive database of information, biological specimens and neuroimages related to the identification, assessment, and treatment of posttraumatic stress disorder (PTSD), insomnia, pain, and related behavioral health conditions. No biospecimen data is being collected in this study.
Anticipated study duration is 24 months to obtaining, cleaning and analysis of the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | tDCS Plus WET | Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET) Soterix 1x1 tDCS mini CT: During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize. Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2024 |
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Early phase II, two-arm, partially double-blind pilot research clinical trial
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Subjects will be blinded to whether they receive actual tDCS or sham treatment. All study team members will also be blinded to randomization, with the exception of the study team coordinator who will allocate device codes. This will allow for the blind to be broken in case of an emergency or serious adverse event.
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| Sham Soterix 1x1 tDCS Mini CT | Other | Sham setting is used on the Soterix transcranial electrical stimulator |
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| Written Exposure Therapy (WET) | Behavioral | An exposure-based, behavioral psychotherapy for PTSD. |
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| Baseline to 9 weeks (one month post study treatment) |
| Patient Health Questionnaire-9 (PHQ) | The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms. It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders. Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores range from 0-27, with lower scores indicating less depression severity. | Baseline to 9 weeks (one month post study treatment) |
| Generalize Anxiety Disorder-7 (GAD) | The GAD-7will be used to assess generalized anxiety symptomology. This is a 7-item measure that asks participants to rate the frequency with which they have been bothered by anxiety symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores range from 0-21, with lower scores indicating less anxiety severity. | Baseline to 9 weeks (one month post study treatment) |
| FG001 | Sham Plus WET | Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET) Sham Soterix 1x1 tDCS Mini CT: Sham setting is used on the Soterix transcranial electrical stimulator Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | tDCS Plus WET | Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET) Soterix 1x1 tDCS mini CT: During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize. Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD. |
| BG001 | Sham Plus WET | Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET) Sham Soterix 1x1 tDCS Mini CT: Sham setting is used on the Soterix transcranial electrical stimulator Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Posttraumatic Stress Disorder Checklist (PCL-5) | The PCL-5 is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 is currently available and has been shown to have good psychometric properties. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). This measure will be administered at the baseline assessment, prior to each therapy session, and the one-month follow-up assessment. The potential scores range from 0-80, with a lower score indicating less symptoms of PTSD. | Posted | Mean | Standard Error | score on a scale | Baseline to 9 weeks (one month post study treatment) |
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| Primary | Number of Subjects That Completed All 5 WET Sessions | Tracking feasibility through number of subjects that complete all written exposure therapy | Posted | Count of Participants | Participants | 5 weeks |
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| Secondary | Clinician Administer PTSD Scale-5 (CAPS-5) | The CAPS-5 is structured interview that assesses the 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. Additional items that are not included in the total score evaluate overall symptom duration, distress, impairment, dissociative symptoms, and global ratings by the interviewer. Scores range from 0-80, with lower scores indicating less PTSD severity. | Posted | Mean | Standard Error | score on a scale | Baseline to 9 weeks (one month post study treatment) |
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| Secondary | Patient Health Questionnaire-9 (PHQ) | The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms. It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders. Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores range from 0-27, with lower scores indicating less depression severity. | Posted | Mean | Standard Error | score on a scale | Baseline to 9 weeks (one month post study treatment) |
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| Secondary | Generalize Anxiety Disorder-7 (GAD) | The GAD-7will be used to assess generalized anxiety symptomology. This is a 7-item measure that asks participants to rate the frequency with which they have been bothered by anxiety symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores range from 0-21, with lower scores indicating less anxiety severity. | Posted | Mean | Standard Error | score on a scale | Baseline to 9 weeks (one month post study treatment) |
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Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | tDCS Plus WET | Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET) Soterix 1x1 tDCS mini CT: During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize. Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD. | 0 | 12 | 0 | 12 | 10 | 12 |
| EG001 | Sham Plus WET | Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET) Sham Soterix 1x1 tDCS Mini CT: Sham setting is used on the Soterix transcranial electrical stimulator Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD. | 0 | 13 | 0 | 13 | 11 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emotional Distress | Psychiatric disorders | Systematic Assessment |
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| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain in area other than stimulation site (foot, jaw, muscle, neck, throat) |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Reexperiencing | Psychiatric disorders | Systematic Assessment |
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| Sleep Disturbance | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Casey Straud | University of Texas Health Science Center at San Antonio | 210-562-6700 | straud@uthscsa.edu |
| May 13, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 14, 2024 | May 13, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
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| Participants |
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