Clinical trial NCT04327362: TDCS-Augmented Prolonged Exposure Therapy
Official title: TDCS-Augmented Prolonged Exposure Therapy for PTSD: a Multiple Baseline Within-Subject Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Posttraumatic Stress Disorder
PTSD
Anxiety
Depression
Keywords: Non-invasive brain stimulation
Transcranial direct current stimulation
Exposure therapy
Prolonged Exposure
Civilians
Veterans
Trauma
Posttraumatic stress disorder
PTSD
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Clinician-Rated PTSD Symptom Severity
timeFrame: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
measure: Change in Self-Reported PTSD Symptom Severity
timeFrame: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
measure: Change in Self-Reported Post-traumatic Cognitions
timeFrame: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
measure: Change in Depression Symptoms
timeFrame: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
measure: Change in Anxiety Symptoms
timeFrame: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
Secondary outcomes:
measure: Within- and Between-Session Change in Trauma-Related Emotional Distress
timeFrame: During weekly therapy sessions 1-10, for 10 weeks from baseline.
measure: Within- and Between-Session Change in Heart Rate
timeFrame: During weekly therapy sessions 1-10, for 10 weeks from baseline.
measure: Within- and Between-Session Change in Physiological Activation
timeFrame: During weekly therapy sessions 1-10, for 10 weeks from baseline.
measure: Between-Session Change in Trauma Memory Engagement and Emotional Processing
timeFrame: During weekly therapy sessions 1-10, for 10 weeks from baseline.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: National Crime Victim's Research & Treatment Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina & Ralph H. Johnson VAMC Consortium
name: Adam R. Cobb, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina & Ralph H. Johnson VAMC Consortium
name: Lisa M. McTeague, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina & Ralph H. Johnson VAMC Consortium
name: Bethany C. Wangelin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: