Social Anxiety
Conditions
Keywords
social anxiety, transcranial direct current stimulation, exposure therapy
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.
Interventions
tDCS will be applied over EEG coordinate FpZ to target mPFC activation during 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
Sponsors
Study design
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.
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BAT: Matched Audience, Speech Duration | follow-up, one month after baseline assessment | 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.\*\*\* |
| BAT: Matched Audience, Anticipated Anxiety | follow-up, one month after baseline assessment | 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.\*\*\* |
| BAT: Matched Audience, Peak Anxiety | follow-up, one month after baseline assessment | 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.\*\*\* |
| BAT: Unmatched Audience, Speech Duration | follow-up, one month after baseline assessment | 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.\*\*\* |
| BAT: Unmatched Audience, Anticipated Anxiety | follow-up, one month after baseline assessment | 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.\*\*\* |
| BAT: Unmatched Audience, Peak Anxiety | follow-up, one month after baseline assessment | 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.\*\*\* |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Personal Report of Public Speaking Anxiety | follow-up, one month after baseline assessment | 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. |
| Positive Self Statements | follow-up, one month after baseline assessment | 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. |
| Negative Self Statements | follow-up, one month after baseline assessment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anodal tDCS During Exposure anodal transcranial direct current stimulation (2mA) will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy
transcranial direct current stimulation: tDCS will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy
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 | 16 |
| 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
transcranial direct current stimulation: tDCS will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy
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 | 15 |
| Total | 31 |
Baseline characteristics
| Characteristic | Anodal tDCS During Exposure | Sham tDCS During Exposure | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 15 Participants | 31 Participants |
| Age, Continuous | 19.75 years STANDARD_DEVIATION 1.45 | 20 years STANDARD_DEVIATION 1.51 | 19.87 years STANDARD_DEVIATION 1.46 |
| BAT: Matched Audience, Anticipated Anxiety | 70 units on a scale STANDARD_DEVIATION 16 | 64 units on a scale STANDARD_DEVIATION 29 | 67 units on a scale STANDARD_DEVIATION 23 |
| BAT: Matched Audience, Peak Anxiety | 59 units on a scale STANDARD_DEVIATION 31 | 65 units on a scale STANDARD_DEVIATION 24 | 62 units on a scale STANDARD_DEVIATION 27 |
| BAT: Matched Audience, Speech Duration | 112 seconds STANDARD_DEVIATION 49 | 159 seconds STANDARD_DEVIATION 94 | 135 seconds STANDARD_DEVIATION 76 |
| BAT: Unmatched Audience, Anticipated Anxiety | 66 units on a scale STANDARD_DEVIATION 22 | 69 units on a scale STANDARD_DEVIATION 22 | 68 units on a scale STANDARD_DEVIATION 22 |
| BAT: Unmatched Audience, Peak Anxiety | 69 units on a scale STANDARD_DEVIATION 27 | 72 units on a scale STANDARD_DEVIATION 21 | 71 units on a scale STANDARD_DEVIATION 24 |
| BAT: Unmatched Audience, Speech Duration | 121 units on a scale STANDARD_DEVIATION 75 | 155 units on a scale STANDARD_DEVIATION 103 | 137 units on a scale STANDARD_DEVIATION 90 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Negative Self Statements | 14 units on a scale STANDARD_DEVIATION 3 | 13 units on a scale STANDARD_DEVIATION 4 | 14 units on a scale STANDARD_DEVIATION 4 |
| Personal Report of Public Speaking Anxiety | 149 units on a scale STANDARD_DEVIATION 9 | 145 units on a scale STANDARD_DEVIATION 11 | 147 units on a scale STANDARD_DEVIATION 10 |
| Positive Self Statements | 10 units on a scale STANDARD_DEVIATION 3 | 10 units on a scale STANDARD_DEVIATION 4 | 10 units on a scale STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 13 Participants | 26 Participants |
| Region of Enrollment United States | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Female | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
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.\*\*\*
Time frame: follow-up, one month after baseline assessment
Population: Completer only (no imputation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS During Exposure | BAT: Matched Audience, Anticipated Anxiety | 39 units on a scale | Standard Deviation 19 |
| Sham tDCS During Exposure | BAT: Matched Audience, Anticipated Anxiety | 38 units on a scale | Standard Deviation 25 |
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.\*\*\*
Time frame: follow-up, one month after baseline assessment
Population: completers only (no imputation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS During Exposure | BAT: Matched Audience, Peak Anxiety | 36 units on a scale | Standard Deviation 21 |
| Sham tDCS During Exposure | BAT: Matched Audience, Peak Anxiety | 26 units on a scale | Standard Deviation 27 |
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.\*\*\*
Time frame: follow-up, one month after baseline assessment
Population: Completer-only analysis (no imputation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS During Exposure | BAT: Matched Audience, Speech Duration | 129 seconds | Standard Deviation 52 |
| Sham tDCS During Exposure | BAT: Matched Audience, Speech Duration | 141 seconds | Standard Deviation 65 |
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.\*\*\*
Time frame: follow-up, one month after baseline assessment
Population: completers only (no imputation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS During Exposure | BAT: Unmatched Audience, Anticipated Anxiety | 43 units on a scale | Standard Deviation 21 |
| Sham tDCS During Exposure | BAT: Unmatched Audience, Anticipated Anxiety | 40 units on a scale | Standard Deviation 25 |
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.\*\*\*
Time frame: follow-up, one month after baseline assessment
Population: completers only (no imputation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS During Exposure | BAT: Unmatched Audience, Peak Anxiety | 35 units on a scale | Standard Deviation 21 |
| Sham tDCS During Exposure | BAT: Unmatched Audience, Peak Anxiety | 28 units on a scale | Standard Deviation 24 |
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.\*\*\*
Time frame: follow-up, one month after baseline assessment
Population: completers only (no imputation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS During Exposure | BAT: Unmatched Audience, Speech Duration | 145 seconds | Standard Deviation 60 |
| Sham tDCS During Exposure | BAT: Unmatched Audience, Speech Duration | 168 seconds | Standard Deviation 72 |
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.
Time frame: follow-up, one month after baseline assessment
Population: completers only (no imputation). Note: Three additional participants were excluded from the primary outcome data, but not secondary outcome data. Social distancing guidelines prevented them from attending a lab visit to complete the primary outcome measure (the BATs), but they were able to complete the secondary outcome measures remotely (questionnaires).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS During Exposure | Negative Self Statements | 12.33 score on a scale | Standard Deviation 6.95 |
| Sham tDCS During Exposure | Negative Self Statements | 11.77 score on a scale | Standard Deviation 6.83 |
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.
Time frame: follow-up, one month after baseline assessment
Population: completer only (no imputation). Note: Three additional participants were excluded from the primary outcome data, but not secondary outcome data. Social distancing guidelines prevented them from attending a lab visit to complete the primary outcome measure (the BATs), but they were able to complete the secondary outcome measures remotely (questionnaires).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS During Exposure | Personal Report of Public Speaking Anxiety | 133.47 score on a scale | Standard Deviation 16.69 |
| Sham tDCS During Exposure | Personal Report of Public Speaking Anxiety | 131.15 score on a scale | Standard Deviation 17.87 |
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.
Time frame: follow-up, one month after baseline assessment
Population: completers only (no imputation). Note: Three additional participants were excluded from the primary outcome data, but not secondary outcome data. Social distancing guidelines prevented them from attending a lab visit to complete the primary outcome measure (the BATs), but they were able to complete the secondary outcome measures remotely (questionnaires).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS During Exposure | Positive Self Statements | 11.13 score on a scale | Standard Deviation 5.14 |
| Sham tDCS During Exposure | Positive Self Statements | 10.69 score on a scale | Standard Deviation 4.57 |