Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation

This study will examine whether transcranial direct current stimulation (tDCS) can be used to improve outcomes from exposure therapy for social anxiety disorder, and facilitate extinction of fear responding toward individuals outside one's own ethnic group (i.e., ethnic out-group members).

Study Overview

• Status: Terminated
• Conditions: Social Anxiety
• Intervention / Treatment: Device: transcranial direct current stimulation; Behavioral: exposure therapy

Detailed Description

Although exposure therapy is among the most powerful treatment techniques for social anxiety, many individuals do not achieve full remission. Furthermore, some research suggests that fear responding toward ethnic out-group members may be more resistant to extinction. Enhancing activation of the mPFC during exposure therapy may improve overall response to treatment, and also facilitate extinction of fear toward ethic out-groups. Researchers have found that greater mPFC activation during exposure therapy is associated with better outcomes, and that transcranial direct current stimulation (tDCS) can be used enhance learning and cognition with no known serious adverse effects. This study will therefore examine whether active/anodal (versus sham) tDCS targeting the mPFC (a) enhances overall reductions in social anxiety symptoms, and (b) facilitates extinction of fear responding toward ethnic/racial out-groups for both Latino and Caucasian/non-Latino participants. Participants will receive either active/anodal tDCS or sham tDCS during a brief exposure therapy intervention involving public speaking in a Virtual Reality (VR) environment. The public speaking audience in the VR environment will alternate between audiences that are either matched or unmatched to the participant's ethnicity (in a randomly assigned order). Participants' fear reactivity will be assessed with behavioral, physiological, and subjective measures at baseline, post-treatment, and follow-up.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89557
      • University of Nevada, Reno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or older (adult)
• Enrolled in higher education (post-high school)
• Elevated public speaking anxiety as indicated by self-report questions
• NOT currently receiving in exposure therapy for social anxiety

Exclusion Criteria:

• History of seizure or any other neurological diagnosis
• Has any metal in their skull (plates, steel sutures, etc.)
• Participant is currently taking anti-convulsant, sedative/hypnotic, or antipsychotic medications
• Participant is pregnant
• Participant has already participated in a prior tDCS/tACS study on the same day as study visit 1 (which will involve either placebo or active/anodal tDCS stimulation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: anodal tDCS during exposure; anodal transcranial direct current stimulation (2mA) will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy	Device: transcranial direct current stimulation; tDCS will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy; Behavioral: exposure therapy; participants will complete one session of exposure therapy for fear of public speaking, which will involve providing speeches to audiences in virtual reality
Sham Comparator: sham tDCS during exposure; sham transcranial direct current stimulation will be applied over EEG coordinate FpZ during exposure therapy at a level that provides the physical sensations of tDCS but which is non-therapeutic	Device: transcranial direct current stimulation; tDCS will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy; Behavioral: exposure therapy; participants will complete one session of exposure therapy for fear of public speaking, which will involve providing speeches to audiences in virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BAT: Matched Audience, Speech Duration	During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak fear). ***This outcome report is for the duration of the matched BAT. The total possible range of the speech is from 0 to 300 seconds. Longer speech durations indicate greater approach, which is a better outcome.***	follow-up, one month after baseline assessment
BAT: Matched Audience, Anticipated Anxiety	During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety). ***This outcome report is for anticipated anxiety during the matched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.***	follow-up, one month after baseline assessment
BAT: Matched Audience, Peak Anxiety	During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety). ***This outcome report is for peak anxiety during the matched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.***	follow-up, one month after baseline assessment
BAT: Unmatched Audience, Speech Duration	During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak fear). ***This outcome report is for the duration of the unmatched BAT. The total possible range of the speech is from 0 to 300 seconds. Longer speech durations indicate greater approach, which is a better outcome.***	follow-up, one month after baseline assessment
BAT: Unmatched Audience, Anticipated Anxiety	During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety). ***This outcome report is for anticipated anxiety during the unmatched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.***	follow-up, one month after baseline assessment
BAT: Unmatched Audience, Peak Anxiety	During Behavioral Approach Tests (BATs), participants will provide a speech to (a) an audience primarily matched to their ethnicity, and (b) an audience primarily un-matched to their ethnicity. The speech will be for up to 5 minutes in duration. During each BAT, we will assess fear response behaviorally (length of the speech, up to 5 min in duration) and subjectively (self reported levels of anticipated and peak anxiety). ***This outcome report is for peak anxiety during the unmatched BAT. The total possible range of the subjective rating is from 0 to 100. Higher ratings indicate greater anxiety, which is a worse outcome.***	follow-up, one month after baseline assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Report of Public Speaking Anxiety	Participants will complete the Personal Report of Public Speaking Anxiety (PRPSA), a 34-item questionnaire that assesses public speaking anxiety. The items are sum scored, and totals range from 34 to 170, with higher scores indicating higher levels of public speaking anxiety.	follow-up, one month after baseline assessment
Positive Self Statements	Participants will complete the Positive Self Statements subscale of the Self Statements During Public Speaking Scale (SSPS). The SSPS is 10-item questionnaire that asses both positive and negative self statements associated with public speaking. The items within each of the two subscales are summed, with total scores ranging from 0 to 25 for each subscale, and higher scores indicating higher levels of agreement with positive or negative self statements, respectively. Higher scores on the positive self statements indicate less anxiety.	follow-up, one month after baseline assessment
Negative Self Statements	Participants will complete the Negative Self Statements subscale of the Self Statements During Public Speaking Scale (SSPS). The SSPS is 10-item questionnaire that asses both positive and negative self statements associated with public speaking. The items within each of the two subscales are summed, with total scores ranging from 0 to 25 for each subscale, and higher scores indicating higher levels of agreement with positive or negative self statements, respectively. Higher scores on the negative self statements indicate more anxiety.	follow-up, one month after baseline assessment

Collaborators and Investigators

• Sponsor: University of Nevada, Reno

Publications and helpful links

General Publications

• McDonald MA, Meckes SJ, Shires J, Berryhill ME, Lancaster CL. Augmenting Virtual Reality Exposure Therapy for Social and Intergroup Anxiety With Transcranial Direct Current Stimulation. J ECT. 2024 Mar 1;40(1):51-60. doi: 10.1097/YCT.0000000000000967. Epub 2023 Nov 24.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): March 5, 2020
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; social anxiety; exposure therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Desensitization, Psychologic; Transcranial Direct Current Stimulation; Implosive Therapy
• Other Study ID Numbers: 1222479-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study protocols and de-identified data will be shared at the request of other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes