Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation
Primary Purpose
Social Anxiety
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation
exposure therapy
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety focused on measuring social anxiety, transcranial direct current stimulation, exposure therapy
Eligibility 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)
Sites / Locations
- University of Nevada, Reno
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
anodal tDCS during exposure
sham tDCS during exposure
Arm Description
anodal transcranial direct current stimulation (2mA) will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy
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
Outcomes
Primary Outcome Measures
Behavioral approach test
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
Public Speaking Anxiety Scale (PSAS)
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.
Brief Fear of Negative Evaluation Scale-II (BFNE)
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.
Self Statements During Public Speaking Scale (SSPS)
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.
Full Information
NCT ID
NCT03743571
First Posted
November 9, 2018
Last Updated
May 27, 2022
Sponsor
University of Nevada, Reno
1. Study Identification
Unique Protocol Identification Number
NCT03743571
Brief Title
Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation
Official Title
Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Suspended
Why Stopped
recruitment suspended due to COVID-related social distancing requirements
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nevada, Reno
4. Oversight
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
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety
Keywords
social anxiety, transcranial direct current stimulation, exposure therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anodal tDCS during exposure
Arm Type
Active Comparator
Arm Description
anodal transcranial direct current stimulation (2mA) will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy
Arm Title
sham tDCS during exposure
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
tDCS will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy
Intervention Type
Behavioral
Intervention Name(s)
exposure therapy
Intervention Description
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 Measure Information:
Title
Behavioral approach test
Description
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).
Time Frame
change from baseline to one-month follow-up
Secondary Outcome Measure Information:
Title
Public Speaking Anxiety Scale (PSAS)
Description
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.
Time Frame
change from baseline to one-month follow-up
Title
Brief Fear of Negative Evaluation Scale-II (BFNE)
Description
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.
Time Frame
change from baseline to one-month follow-up
Title
Self Statements During Public Speaking Scale (SSPS)
Description
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.
Time Frame
change from baseline to one-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
University of Nevada, Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study protocols and de-identified data will be shared at the request of other researchers.
Learn more about this trial
Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation
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