tDCS-Augmented Prolonged Exposure Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anxiety
- Depression
- Posttraumatic Stress Disorder
- PTSD
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Participants will be randomly assigned following stratification by baseline severity of PTSD symptoms, medication status, and sex to one of five clusters defined by the point of cross-over from sham to active tDCS administered just prior to PE therapy sessions, with the earliest cross-over occurring at session 4, and the latest at session 8.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Customized software involving use of a coding scheme will be used to allow complete blinding to whether active or sham tDCS is administered. The participants, tDCS administrators, therapists, and outcome assessors will remain blind to tDCS condition. The integrity of blinding procedures will be evaluated by self-report questionnaires administered at each treatment visit.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 chron...
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.
Tracking Information
- NCT #
- NCT04327362
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Adam R. Cobb, Ph.D. Medical University of South Carolina & Ralph H. Johnson VAMC Consortium Principal Investigator: Lisa M. McTeague, Ph.D. Medical University of South Carolina & Ralph H. Johnson VAMC Consortium Principal Investigator: Bethany C. Wangelin, Ph.D. Medical University of South Carolina & Ralph H. Johnson VAMC Consortium
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