TDCS-Augmented Prolonged Exposure Therapy

NCT ID: NCT04327362

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-05-01

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.

Conditions

Posttraumatic Stress Disorder; PTSD; Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cluster 1: Sham to active tDCS crossover at PE Session 4.

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.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Participants will receive 20 min. of either sham or active tDCS prior to PE sessions using a 1 x 1 tDCS device with a ring electrode configuration that allows relatively excitatory and focal stimulation of the dorsomedial prefrontal cortex (dmPFC). Electrodes consist of sponges in a silicone rubber holder with a metal mesh conductor saturated with normal saline. A center anode (2.5 cm diameter) and a ring-shaped cathode (diameter inner/outer: 9.2/11.50 cm) will be centered over the dmPFC, with the anode placed the midline at 15% of the Fz to FPz distance. Active stimulation will commence with a 15 sec. ramping up period to target current (1.5 mA), followed by constant current for 20 min., and a 15 sec. ramping down period. For all sham sessions, stimulation will be immediately ramped down over a 15 sec. period following the initial ramping up period, and subsequently ramped up over 15 sec. prior to the final ramping down period.

Prolonged Exposure Therapy

Intervention Type: BEHAVIORAL

All participants will receive 10 weekly sessions of standard Prolonged Exposure Therapy, or PE, which is a gold standard trauma-focused cognitive behavioral treatment for PTSD. The first sessions (1-2) predominately consist of psychoeducation about PTSD and the rationale for treatment, whereas subsequent sessions (3-10) consist of imaginal and in vivo exposure, involving repeated, prolonged, systematic, and deliberate practice approaching trauma reminders, as well as cognitive and emotional processing reactions to an index trauma memory.

Cluster 2: Sham to active tDCS crossover at PE Session 5.

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Participants will receive 20 min. of either sham or active tDCS prior to PE sessions using a 1 x 1 tDCS device with a ring electrode configuration that allows relatively excitatory and focal stimulation of the dorsomedial prefrontal cortex (dmPFC). Electrodes consist of sponges in a silicone rubber holder with a metal mesh conductor saturated with normal saline. A center anode (2.5 cm diameter) and a ring-shaped cathode (diameter inner/outer: 9.2/11.50 cm) will be centered over the dmPFC, with the anode placed the midline at 15% of the Fz to FPz distance. Active stimulation will commence with a 15 sec. ramping up period to target current (1.5 mA), followed by constant current for 20 min., and a 15 sec. ramping down period. For all sham sessions, stimulation will be immediately ramped down over a 15 sec. period following the initial ramping up period, and subsequently ramped up over 15 sec. prior to the final ramping down period.

Prolonged Exposure Therapy

Intervention Type: BEHAVIORAL

All participants will receive 10 weekly sessions of standard Prolonged Exposure Therapy, or PE, which is a gold standard trauma-focused cognitive behavioral treatment for PTSD. The first sessions (1-2) predominately consist of psychoeducation about PTSD and the rationale for treatment, whereas subsequent sessions (3-10) consist of imaginal and in vivo exposure, involving repeated, prolonged, systematic, and deliberate practice approaching trauma reminders, as well as cognitive and emotional processing reactions to an index trauma memory.

Cluster 3: Sham to active tDCS crossover at PE Session 6

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Participants will receive 20 min. of either sham or active tDCS prior to PE sessions using a 1 x 1 tDCS device with a ring electrode configuration that allows relatively excitatory and focal stimulation of the dorsomedial prefrontal cortex (dmPFC). Electrodes consist of sponges in a silicone rubber holder with a metal mesh conductor saturated with normal saline. A center anode (2.5 cm diameter) and a ring-shaped cathode (diameter inner/outer: 9.2/11.50 cm) will be centered over the dmPFC, with the anode placed the midline at 15% of the Fz to FPz distance. Active stimulation will commence with a 15 sec. ramping up period to target current (1.5 mA), followed by constant current for 20 min., and a 15 sec. ramping down period. For all sham sessions, stimulation will be immediately ramped down over a 15 sec. period following the initial ramping up period, and subsequently ramped up over 15 sec. prior to the final ramping down period.

Prolonged Exposure Therapy

Intervention Type: BEHAVIORAL

All participants will receive 10 weekly sessions of standard Prolonged Exposure Therapy, or PE, which is a gold standard trauma-focused cognitive behavioral treatment for PTSD. The first sessions (1-2) predominately consist of psychoeducation about PTSD and the rationale for treatment, whereas subsequent sessions (3-10) consist of imaginal and in vivo exposure, involving repeated, prolonged, systematic, and deliberate practice approaching trauma reminders, as well as cognitive and emotional processing reactions to an index trauma memory.

Cluster 4: Sham to active tDCS crossover at PE Session 7.

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Participants will receive 20 min. of either sham or active tDCS prior to PE sessions using a 1 x 1 tDCS device with a ring electrode configuration that allows relatively excitatory and focal stimulation of the dorsomedial prefrontal cortex (dmPFC). Electrodes consist of sponges in a silicone rubber holder with a metal mesh conductor saturated with normal saline. A center anode (2.5 cm diameter) and a ring-shaped cathode (diameter inner/outer: 9.2/11.50 cm) will be centered over the dmPFC, with the anode placed the midline at 15% of the Fz to FPz distance. Active stimulation will commence with a 15 sec. ramping up period to target current (1.5 mA), followed by constant current for 20 min., and a 15 sec. ramping down period. For all sham sessions, stimulation will be immediately ramped down over a 15 sec. period following the initial ramping up period, and subsequently ramped up over 15 sec. prior to the final ramping down period.

Prolonged Exposure Therapy

Intervention Type: BEHAVIORAL

All participants will receive 10 weekly sessions of standard Prolonged Exposure Therapy, or PE, which is a gold standard trauma-focused cognitive behavioral treatment for PTSD. The first sessions (1-2) predominately consist of psychoeducation about PTSD and the rationale for treatment, whereas subsequent sessions (3-10) consist of imaginal and in vivo exposure, involving repeated, prolonged, systematic, and deliberate practice approaching trauma reminders, as well as cognitive and emotional processing reactions to an index trauma memory.

Cluster 5: Sham to active tDCS crossover at PE Session 8.

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Participants will receive 20 min. of either sham or active tDCS prior to PE sessions using a 1 x 1 tDCS device with a ring electrode configuration that allows relatively excitatory and focal stimulation of the dorsomedial prefrontal cortex (dmPFC). Electrodes consist of sponges in a silicone rubber holder with a metal mesh conductor saturated with normal saline. A center anode (2.5 cm diameter) and a ring-shaped cathode (diameter inner/outer: 9.2/11.50 cm) will be centered over the dmPFC, with the anode placed the midline at 15% of the Fz to FPz distance. Active stimulation will commence with a 15 sec. ramping up period to target current (1.5 mA), followed by constant current for 20 min., and a 15 sec. ramping down period. For all sham sessions, stimulation will be immediately ramped down over a 15 sec. period following the initial ramping up period, and subsequently ramped up over 15 sec. prior to the final ramping down period.

Prolonged Exposure Therapy

Intervention Type: BEHAVIORAL

All participants will receive 10 weekly sessions of standard Prolonged Exposure Therapy, or PE, which is a gold standard trauma-focused cognitive behavioral treatment for PTSD. The first sessions (1-2) predominately consist of psychoeducation about PTSD and the rationale for treatment, whereas subsequent sessions (3-10) consist of imaginal and in vivo exposure, involving repeated, prolonged, systematic, and deliberate practice approaching trauma reminders, as well as cognitive and emotional processing reactions to an index trauma memory.

Interventions

Transcranial Direct Current Stimulation (tDCS)

Participants will receive 20 min. of either sham or active tDCS prior to PE sessions using a 1 x 1 tDCS device with a ring electrode configuration that allows relatively excitatory and focal stimulation of the dorsomedial prefrontal cortex (dmPFC). Electrodes consist of sponges in a silicone rubber holder with a metal mesh conductor saturated with normal saline. A center anode (2.5 cm diameter) and a ring-shaped cathode (diameter inner/outer: 9.2/11.50 cm) will be centered over the dmPFC, with the anode placed the midline at 15% of the Fz to FPz distance. Active stimulation will commence with a 15 sec. ramping up period to target current (1.5 mA), followed by constant current for 20 min., and a 15 sec. ramping down period. For all sham sessions, stimulation will be immediately ramped down over a 15 sec. period following the initial ramping up period, and subsequently ramped up over 15 sec. prior to the final ramping down period.

Intervention Type: DEVICE

Prolonged Exposure Therapy

All participants will receive 10 weekly sessions of standard Prolonged Exposure Therapy, or PE, which is a gold standard trauma-focused cognitive behavioral treatment for PTSD. The first sessions (1-2) predominately consist of psychoeducation about PTSD and the rationale for treatment, whereas subsequent sessions (3-10) consist of imaginal and in vivo exposure, involving repeated, prolonged, systematic, and deliberate practice approaching trauma reminders, as well as cognitive and emotional processing reactions to an index trauma memory.

Intervention Type: BEHAVIORAL

Other Intervention Names

Soterix Medical 1 x 1 Transcranial Electrical Stimulator (tES); PE; CBT; Trauma-focused therapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam R. Cobb, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina & Ralph H. Johnson VAMC Consortium

Lisa M. McTeague, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina & Ralph H. Johnson VAMC Consortium

Bethany C. Wangelin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina & Ralph H. Johnson VAMC Consortium

Locations

National Crime Victim's Research & Treatment Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

00093774

Identifier Type: -

Identifier Source: org_study_id