TDCS-Augmented Prolonged Exposure Therapy
- Conditions
- AnxietyDepressionPosttraumatic Stress DisorderPTSD
- Interventions
- Device: Transcranial Direct Current Stimulation (tDCS)Behavioral: Prolonged Exposure Therapy
- Registration Number
- NCT04327362
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
The purpose of this study is to determine the effects of a brain stimulation technique known as transcranial direct current stimulation, or tDCS, on the benefits of Prolonged Exposure therapy, or PE, which is an effective treatment for posttraumatic stress disorder, or PTSD. tDCS has been demonstrated to be safe and effective for influencing brain activity by passing a weak electrical current through the scalp. In this study, tDCS is provided in addition to PE treatment, through the National Crime Victim's Research and Treatment Center at MUSC, or the PTSD Clinical Team Clinic within the Ralph H. Johnson VA Medical Center.
- Detailed Description
This project implements a multiple baseline within-subject clinical trial design aiming to test whether tDCS targeting excitation of the medial prefrontal cortex (mPFC) can enhance a standard course of PE in a sample of adult civilians and Veterans (ages 18-65) who meet full DSM-5 criteria for chronic PTSD (i.e., \> 3 months post-trauma; N = 20). All participants will receive a total of ten 60-min. sessions of manualized PE, preceded by 20 min. of either active or sham HD-tDCS. The stepped-wedge multiple baseline design features tDCS as a 2-level within-subject factor (Sham tDCS+PE vs. Active tDCS+PE), and between-subject comparisons based on stratified random assignment to cross-over from sham to active tDCS just prior to sessions 4 through 8. Strata will be defined by dichotomous classifications of possible confounds, including baseline severity (moderate vs. severe), psychotropic medication status (no vs. yes), and sex (female vs. male). The sample will consist of treatment-seeking civilian and Veteran participants referred by either of two of our consortium sites, including the National Crime Victim's Research and Treatment Center (NCVC) at MUSC, or the PTSD Clinical Team (PCT) at the Ralph H. Johnson VAMC, as well as community participants who respond to study advertisements.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age 18-65.
- Fluent in English.
- Diagnosis of chronic PTSD based on MINI for DSM-5 (> 3 mo. post-trauma)
- For Veterans recruited at the Ralph H. Johnson VA only: eligible to receive PE in the PCT clinic.
- Currently receiving psychotherapy for another anxiety- or stress-related condition.
- Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment
- Medical condition that would contraindicate participation in treatment or assessment activities (e.g., severe cardiovascular problems).
- Pregnancy
- Current severe major depressive disorder
- Current, or history of bipolar disorder
- Current, or history of psychotic symptoms
- Serious suicidal risk
- Active neurological conditions, e.g., seizures, stroke, loss of consciousness or concussion
- Contraindications for tDCS:
- Metal in the head.
- Implanted brain medical devices.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cluster 1: Sham to active tDCS crossover at PE Session 4. Prolonged Exposure Therapy Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-3, and 20 min. of active tDCS prior to PE sessions 4-10. Cluster 1: Sham to active tDCS crossover at PE Session 4. Transcranial Direct Current Stimulation (tDCS) Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-3, and 20 min. of active tDCS prior to PE sessions 4-10. Cluster 2: Sham to active tDCS crossover at PE Session 5. Prolonged Exposure Therapy Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-4, and 20 min. of active tDCS prior to PE sessions 5-10. Cluster 3: Sham to active tDCS crossover at PE Session 6 Transcranial Direct Current Stimulation (tDCS) Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-5, and 20 min. of active tDCS prior to PE sessions 6-10. Cluster 2: Sham to active tDCS crossover at PE Session 5. Transcranial Direct Current Stimulation (tDCS) Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-4, and 20 min. of active tDCS prior to PE sessions 5-10. Cluster 4: Sham to active tDCS crossover at PE Session 7. Transcranial Direct Current Stimulation (tDCS) Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-6, and 20 min. of active tDCS prior to PE sessions 7-10. Cluster 3: Sham to active tDCS crossover at PE Session 6 Prolonged Exposure Therapy Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-5, and 20 min. of active tDCS prior to PE sessions 6-10. Cluster 4: Sham to active tDCS crossover at PE Session 7. Prolonged Exposure Therapy Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-6, and 20 min. of active tDCS prior to PE sessions 7-10. Cluster 5: Sham to active tDCS crossover at PE Session 8. Prolonged Exposure Therapy Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-7, and 20 min. of active tDCS prior to PE sessions 8-10. Cluster 5: Sham to active tDCS crossover at PE Session 8. Transcranial Direct Current Stimulation (tDCS) Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-7, and 20 min. of active tDCS prior to PE sessions 8-10.
- Primary Outcome Measures
Name Time Method Change in Depression Symptoms Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline) Self-report scores on the Beck Depression Inventory, 2nd Edition (BDI-II)
Total scores range from 0 to 63, with higher scores indicating greater severity of depression symptoms.Change in Clinician-Rated PTSD Symptom Severity Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline) Clinician-administered PTSD Symptom Scale Interview for DSM-5 (PSSI-5).
Total scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.Change in Self-Reported PTSD Symptom Severity Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline) Self-report scores on the PTSD Symptom Checklist for DSM-5 (PCL-5)
Total scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.Change in Self-Reported Post-traumatic Cognitions Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline) Self-report scores on the Post-traumatic Cognitions Inventory (PTCI-9)
Total scores range from 9 to 63, with high scores indicating greater endorsement of common and problematic trauma-related beliefs.Change in Anxiety Symptoms Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline) Self-report scores on the Beck Anxiety Inventory (BAI)
Total scores range from 0 to 63, with higher scores indicating greater severity of anxiety symptoms.
- Secondary Outcome Measures
Name Time Method Within- and Between-Session Change in Trauma-Related Emotional Distress During weekly therapy sessions 1-10, for 10 weeks from baseline. Self-reported in-session Subjective Units of Distress Scale (SUDS)
Peak distress among repeated ratings obtained during therapy sessions from 0 = "no distress" to 100 = "extreme distress". Ratings will be obtained up to 13 times at each weekly Prolonged Exposure therapy session, for 10 weeks.Within- and Between-Session Change in Physiological Activation During weekly therapy sessions 1-10, for 10 weeks from baseline. Continuously recorded in-session skin conductance levels
Skin conductance levels will be continuously monitored during each weekly Prolonged Exposure therapy session, for 10 weeks.Between-Session Change in Trauma Memory Engagement and Emotional Processing During weekly therapy sessions 1-10, for 10 weeks from baseline. Therapist-report scores on the Prolonged Exposure Therapist Questionnaire
Total scores range from 0 to 35, with higher scores indicating greater retrieval, processing, and meaning making during imaginal revisiting of the index trauma memory.Within- and Between-Session Change in Heart Rate During weekly therapy sessions 1-10, for 10 weeks from baseline. Continuously recorded in-session heart rate
Heart rate will be continuously recorded during each weekly Prolonged Exposure therapy session, for 10 weeks.
Trial Locations
- Locations (1)
National Crime Victim's Research & Treatment Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States