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Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation

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ClinicalTrials.gov Identifier: NCT03743571
Recruitment Status : Suspended (recruitment suspended due to COVID-related social distancing requirements)
First Posted : November 16, 2018
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
University of Nevada, Reno

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).

Condition or disease Intervention/treatment Phase
Social Anxiety Device: transcranial direct current stimulation Behavioral: exposure therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to receive either sham or anodal (2 mA) tDCS targeting the mPFC during exposure therapy for public speaking anxiety.
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. Behavioral approach test [ Time Frame: change from baseline to one-month follow-up ]
    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), physiologically (heart rate and electrodermal activity), and subjectively (self reported levels of anticipated and peak fear).


Secondary Outcome Measures :
  1. Public Speaking Anxiety Scale (PSAS) [ Time Frame: change from baseline to one-month follow-up ]
    Participants will complete the PSAS, a 17-item questionnaire that assesses self-reported behavioral, cognitive, and physiological manifestations of public speaking anxiety. The items are sum scored, and totals range from 17 to 85, with higher scores indicating higher levels of public speaking anxiety.

  2. Brief Fear of Negative Evaluation Scale-II (BFNE) [ Time Frame: change from baseline to one-month follow-up ]
    Participants will complete the BFNE-II, a 12-item questionnaire that assesses the extent to which one has concerns about negative evaluation in social settings. A sum score is calculated for the scale, with total scores ranging from 12 to 60, and higher scores indicating higher levels of fear of negative evaluation.

  3. Self Statements During Public Speaking Scale (SSPS) [ Time Frame: change from baseline to one-month follow-up ]
    Participants will complete the SSPS, a 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743571


Locations
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United States, Nevada
University of Nevada, Reno
Reno, Nevada, United States, 89557
Sponsors and Collaborators
University of Nevada, Reno
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Responsible Party: University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT03743571    
Other Study ID Numbers: 1222479-2
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study protocols and de-identified data will be shared at the request of other researchers.

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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
Keywords provided by University of Nevada, Reno:
social anxiety
transcranial direct current stimulation
exposure therapy
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders