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recruitment terminated due to COVID-related social distancing requirements
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | tDCS will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | follow-up, one month after baseline assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nevada, Reno | Reno | Nevada | 89557 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38009966 | Result | 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. |
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Study protocols and de-identified data will be shared at the request of other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who withdrew from the study (n = 2) were not included in the baseline data.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.*** | Completer-only analysis (no imputation). | Posted | Mean | Standard Deviation | seconds | follow-up, one month after baseline assessment |
|
The timeframe for data collection for the project. This included baseline (enrollment day) through follow-up, which was approximately one month after enrollment.
Definitions were consistent with clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Lancaster | University of Nevada Reno | (775) 682-8144 | cynthialancaster@unr.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2020 | Aug 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D007171 | Implosive Therapy |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Participants will be randomly assigned to receive either sham or anodal (2 mA) tDCS targeting the mPFC during exposure therapy for public speaking anxiety.
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| 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 |
|
| 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 |
| 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. | follow-up, one month after baseline assessment |
| 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. | follow-up, one month after baseline assessment |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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 report is for the baseline duration of the matched BAT. The range is from 0 to 300 seconds. Longer speech durations indicate greater approach, and a better outcome.*** | Mean | Standard Deviation | seconds |
|
| BAT: Matched Audience, Anticipated Anxiety | During Behavioral Approach Tests (BATs), participants 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 report is for the baseline anticipated anxiety rating for the matched BAT. The range of the subjective rating is 0 to 100, with higher scores indicating a worse outcome.** | Anticipated anxiety ratings at baseline (BAT matched and unmatched) were missing for one participant in the anodal tDCS condition (n= 15 total, instead of n = 16 for this measure only), due to an experimenter error. | Mean | Standard Deviation | units on a scale |
|
| BAT: Matched Audience, Peak Anxiety | During Behavioral Approach Tests (BATs), participants 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 report is for the baseline peak anxiety rating for the matched BAT. The range of the subjective rating is 0 to 100, with higher scores indicating a worse outcome.*** | Mean | Standard Deviation | units on a scale |
|
| 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 report is for the baseline duration of the unmatched BAT. The range is from 0 to 300 seconds. Longer speech durations indicate greater approach, and a better outcome.*** | Mean | Standard Deviation | units on a scale |
|
| BAT: Unmatched Audience, Anticipated Anxiety | During Behavioral Approach Tests (BATs), participants 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 report is for the baseline anticipated anxiety rating for the unmatched BAT. The range of the subjective rating is 0 to 100, with higher scores indicating a worse outcome.* | Anticipated anxiety ratings at baseline (BAT matched and unmatched) were missing for one participant in the anodal tDCS condition (n= 15 total, instead of n = 16 for this measure only), due to an experimenter error. | Mean | Standard Deviation | units on a scale |
|
| BAT: Unmatched Audience, Peak Anxiety | During Behavioral Approach Tests (BATs), participants 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 report is for the baseline peak anxiety rating for the unmatched BAT. The range of the subjective rating is 0 to 100, with higher scores indicating a worse outcome.*** | Mean | Standard Deviation | units on a scale |
|
| 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 a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| 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 a better outcome. | Mean | Standard Deviation | units on a scale |
|
| 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 a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 |
|
|
|
| Primary | 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.*** | Completer only (no imputation). | Posted | Mean | Standard Deviation | units on a scale | follow-up, one month after baseline assessment |
|
|
|
|
| Primary | 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.*** | completers only (no imputation). | Posted | Mean | Standard Deviation | units on a scale | follow-up, one month after baseline assessment |
|
|
|
|
| Primary | 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.*** | completers only (no imputation). | Posted | Mean | Standard Deviation | seconds | follow-up, one month after baseline assessment |
|
|
|
|
| Primary | 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.*** | completers only (no imputation). | Posted | Mean | Standard Deviation | units on a scale | follow-up, one month after baseline assessment |
|
|
|
|
| Primary | 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.*** | completers only (no imputation). | Posted | Mean | Standard Deviation | units on a scale | follow-up, one month after baseline assessment |
|
|
|
|
| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | follow-up, one month after baseline assessment |
|
|
|
|
| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | follow-up, one month after baseline assessment |
|
|
|
|
| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | follow-up, one month after baseline assessment |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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 | 0 | 15 | 0 | 15 | 0 | 15 |
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Not provided
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham). |
We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham). |
We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham). |
We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham). |
We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham). |
We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).
We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).
We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham),