Post Traumatic Stress Disorder
Conditions
Keywords
Brain stimulation
Brief summary
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).
Detailed description
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.
Interventions
DEVICESoterix 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.
OTHERSham Soterix 1x1 tDCS Mini CT
Sham setting is used on the Soterix transcranial electrical stimulator
BEHAVIORALWritten Exposure Therapy (WET)
An exposure-based, behavioral psychotherapy for PTSD.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Early phase II, two-arm, partially double-blind pilot research clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals between the ages of 18 and 65 years old at time of screening. 2. PTSD diagnosis as assessed by the Clinician-Administered Posttraumatic Stress Scale (CAPS-5) 3. Able to write, read, and speak English
Exclusion criteria
1. History of epilepsy or seizures. 2. History of significant intracranial pathology (e.g., severe traumatic brain injury) or neurological disorder (e.g., Stroke, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Alzheimer's, Dementia, Parkinson's, and/or Huntington's). 3. History of skin condition (e.g., eczema, psoriasis) where electrodes will be applied. 4. Electronic implants in the body that could be susceptible to electrical current (e.g., cardiac pacemaker, cochlear implants, medical pump). 5. Metallic objects other than dental appliances/fillings near the site of stimulation 6. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgement). 7. Current moderate or severe substance use disorder. 8. Suicidality and/or psychiatric risk requiring immediate intervention or a higher level of care than can be provided by the study treatment. 9. Change in anticonvulsive or benzodiazepine medication regimen in the past month. 10. History of adverse effects to previous tDCS or other brain stimulation technique. 11. Concurrent engagement in another brain simulation technique or trauma-related psychotherapy for PTSD. 12. Currently pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Disorder Checklist (PCL-5) | Baseline to 9 weeks (one month post study treatment) | 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. |
| Number of Subjects That Completed All 5 WET Sessions | 5 weeks | Tracking feasibility through number of subjects that complete all written exposure therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administer PTSD Scale-5 (CAPS-5) | Baseline to 9 weeks (one month post study treatment) | 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. |
| Patient Health Questionnaire-9 (PHQ) | Baseline to 9 weeks (one month post study treatment) | 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. |
| Generalize Anxiety Disorder-7 (GAD) | Baseline to 9 weeks (one month post study treatment) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | tDCS Plus WET | Total | Sham Plus WET |
|---|---|---|---|
| Age, Continuous | 42.67 years STANDARD_DEVIATION 6.54 | 40.76 years STANDARD_DEVIATION 8.4 | 39.00 years STANDARD_DEVIATION 9.75 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 20 Participants | 11 Participants |
| Region of Enrollment United States | 12 participants | 25 participants | 13 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 10 / 12 | 11 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 |
Outcome results
Primary
Number of Subjects That Completed All 5 WET Sessions
Tracking feasibility through number of subjects that complete all written exposure therapy
Time frame: 5 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS Plus WET | Number of Subjects That Completed All 5 WET Sessions | 12 Participants |
| Sham Plus WET | Number of Subjects That Completed All 5 WET Sessions | 12 Participants |
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.
Time frame: Baseline to 9 weeks (one month post study treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tDCS Plus WET | Posttraumatic Stress Disorder Checklist (PCL-5) | BASELINE | 44.30 score on a scale | Standard Error 3.74 |
| tDCS Plus WET | Posttraumatic Stress Disorder Checklist (PCL-5) | 9 WEEKS | 22.51 score on a scale | Standard Error 3.98 |
| Sham Plus WET | Posttraumatic Stress Disorder Checklist (PCL-5) | BASELINE | 43.38 score on a scale | Standard Error 3.56 |
| Sham Plus WET | Posttraumatic Stress Disorder Checklist (PCL-5) | 9 WEEKS | 25.11 score on a scale | Standard Error 3.78 |
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.
Time frame: Baseline to 9 weeks (one month post study treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tDCS Plus WET | Clinician Administer PTSD Scale-5 (CAPS-5) | BASELINE | 35.95 score on a scale | Standard Error 2.01 |
| tDCS Plus WET | Clinician Administer PTSD Scale-5 (CAPS-5) | 9 WEEKS | 14.65 score on a scale | Standard Error 2.31 |
| Sham Plus WET | Clinician Administer PTSD Scale-5 (CAPS-5) | BASELINE | 35.08 score on a scale | Standard Error 1.93 |
| Sham Plus WET | Clinician Administer PTSD Scale-5 (CAPS-5) | 9 WEEKS | 15.89 score on a scale | Standard Error 2.09 |
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.
Time frame: Baseline to 9 weeks (one month post study treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tDCS Plus WET | Generalize Anxiety Disorder-7 (GAD) | BASELINE | 15.00 score on a scale | Standard Error 1.61 |
| tDCS Plus WET | Generalize Anxiety Disorder-7 (GAD) | 9 WEEKS | 10.30 score on a scale | Standard Error 1.76 |
| Sham Plus WET | Generalize Anxiety Disorder-7 (GAD) | BASELINE | 15.39 score on a scale | Standard Error 1.55 |
| Sham Plus WET | Generalize Anxiety Disorder-7 (GAD) | 9 WEEKS | 9.74 score on a scale | Standard Error 1.6 |
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.
Time frame: Baseline to 9 weeks (one month post study treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tDCS Plus WET | Patient Health Questionnaire-9 (PHQ) | BASELINE | 15.58 score on a scale | Standard Error 1.82 |
| tDCS Plus WET | Patient Health Questionnaire-9 (PHQ) | 9 WEEKS | 11.00 score on a scale | Standard Error 2.07 |
| Sham Plus WET | Patient Health Questionnaire-9 (PHQ) | BASELINE | 15.54 score on a scale | Standard Error 1.75 |
| Sham Plus WET | Patient Health Questionnaire-9 (PHQ) | 9 WEEKS | 10.66 score on a scale | Standard Error 1.88 |