Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation

NCT ID: NCT03743571

Last Updated: 2024-10-22

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-02

Study Completion Date

2020-03-05

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Social Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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anodal tDCS during exposure

anodal transcranial direct current stimulation (2mA) will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

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

exposure therapy

Intervention Type BEHAVIORAL

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

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

Group Type SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

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

exposure therapy

Intervention Type BEHAVIORAL

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

Interventions

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transcranial direct current stimulation

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

Intervention Type DEVICE

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nevada, Reno

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Nevada, Reno

Reno, Nevada, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 38009966 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1222479-2

Identifier Type: -

Identifier Source: org_study_id

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