Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation

NCT03743571 | Terminated Results FDA Device

• 1 other identifier: 1222479-2
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Social Anxiety

Keywords

social anxiety; transcranial direct current stimulation; exposure therapy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Personal Report of Public Speaking Anxiety

  follow-up, one month after baseline assessment

• Positive Self Statements

  follow-up, one month after baseline assessment

• Negative Self Statements

  follow-up, one month after baseline assessment

Study Arms (2)

anodal tDCS during exposure

ACTIVE COMPARATOR

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; Behavioral: exposure therapy

sham tDCS during exposure

SHAM COMPARATOR

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; Behavioral: exposure therapy

Interventions

transcranial direct current stimulation DEVICE

tDCS will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy

anodal tDCS during exposure; sham tDCS during exposure

exposure therapy BEHAVIORAL

participants will complete one session of exposure therapy for fear of public speaking, which will involve providing speeches to audiences in virtual reality

anodal tDCS during exposure; sham tDCS during exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nevada, Reno: lead

Study Sites (1)

University of Nevada, Reno

Reno, Nevada, 89557, United States

Location

Related Publications (1)

• 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.

  PMID: 38009966 RESULT

MeSH Terms

Interventions

Transcranial Direct Current Stimulation; Implosive Therapy

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Desensitization, Psychologic; Behavior Therapy; Psychotherapy

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Cynthia Lancaster
• Organization: University of Nevada Reno

cynthialancaster@unr.edu

(775) 682-8144

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Psychology/Associate Director, Clinical Training

Model Details: Participants will be randomly assigned to receive either sham or anodal (2 mA) tDCS targeting the mPFC during exposure therapy for public speaking anxiety.

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 16, 2018
• Study Start: April 2, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: April 8, 2026
• Results First Posted: October 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)