Trial Outcomes & Findings for Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation (NCT NCT03743571)
NCT ID: NCT03743571
Last Updated: 2024-10-22
Results Overview
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.\*\*\*
TERMINATED
NA
33 participants
follow-up, one month after baseline assessment
2024-10-22
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Anodal tDCS During Exposure
n=16 Participants
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
|
Sham tDCS During Exposure
n=15 Participants
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
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
31 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
19.75 years
STANDARD_DEVIATION 1.45 • n=16 Participants
|
20 years
STANDARD_DEVIATION 1.51 • n=15 Participants
|
19.87 years
STANDARD_DEVIATION 1.46 • n=31 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=16 Participants
|
11 Participants
n=15 Participants
|
25 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=16 Participants
|
4 Participants
n=15 Participants
|
6 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=16 Participants
|
10 Participants
n=15 Participants
|
20 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=16 Participants
|
5 Participants
n=15 Participants
|
11 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=16 Participants
|
13 Participants
n=15 Participants
|
26 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=16 Participants
|
2 Participants
n=15 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
31 Participants
n=31 Participants
|
|
BAT: Matched Audience, Speech Duration
|
112 seconds
STANDARD_DEVIATION 49 • n=16 Participants
|
159 seconds
STANDARD_DEVIATION 94 • n=15 Participants
|
135 seconds
STANDARD_DEVIATION 76 • n=31 Participants
|
|
BAT: Matched Audience, Anticipated Anxiety
|
70 units on a scale
STANDARD_DEVIATION 16 • n=15 Participants • 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.
|
64 units on a scale
STANDARD_DEVIATION 29 • n=15 Participants • 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.
|
67 units on a scale
STANDARD_DEVIATION 23 • n=30 Participants • 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.
|
|
BAT: Matched Audience, Peak Anxiety
|
59 units on a scale
STANDARD_DEVIATION 31 • n=16 Participants
|
65 units on a scale
STANDARD_DEVIATION 24 • n=15 Participants
|
62 units on a scale
STANDARD_DEVIATION 27 • n=31 Participants
|
|
BAT: Unmatched Audience, Speech Duration
|
121 units on a scale
STANDARD_DEVIATION 75 • n=16 Participants
|
155 units on a scale
STANDARD_DEVIATION 103 • n=15 Participants
|
137 units on a scale
STANDARD_DEVIATION 90 • n=31 Participants
|
|
BAT: Unmatched Audience, Anticipated Anxiety
|
66 units on a scale
STANDARD_DEVIATION 22 • n=15 Participants • 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.
|
69 units on a scale
STANDARD_DEVIATION 22 • n=15 Participants • 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.
|
68 units on a scale
STANDARD_DEVIATION 22 • n=30 Participants • 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.
|
|
BAT: Unmatched Audience, Peak Anxiety
|
69 units on a scale
STANDARD_DEVIATION 27 • n=16 Participants
|
72 units on a scale
STANDARD_DEVIATION 21 • n=15 Participants
|
71 units on a scale
STANDARD_DEVIATION 24 • n=31 Participants
|
|
Personal Report of Public Speaking Anxiety
|
149 units on a scale
STANDARD_DEVIATION 9 • n=16 Participants
|
145 units on a scale
STANDARD_DEVIATION 11 • n=15 Participants
|
147 units on a scale
STANDARD_DEVIATION 10 • n=31 Participants
|
|
Positive Self Statements
|
10 units on a scale
STANDARD_DEVIATION 3 • n=16 Participants
|
10 units on a scale
STANDARD_DEVIATION 4 • n=15 Participants
|
10 units on a scale
STANDARD_DEVIATION 4 • n=31 Participants
|
|
Negative Self Statements
|
14 units on a scale
STANDARD_DEVIATION 3 • n=16 Participants
|
13 units on a scale
STANDARD_DEVIATION 4 • n=15 Participants
|
14 units on a scale
STANDARD_DEVIATION 4 • n=31 Participants
|
PRIMARY outcome
Timeframe: follow-up, one month after baseline assessmentPopulation: Completer-only analysis (no imputation).
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.\*\*\*
Outcome measures
| Measure |
Anodal tDCS During Exposure
n=14 Participants
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
|
Sham tDCS During Exposure
n=12 Participants
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
|
|---|---|---|
|
BAT: Matched Audience, Speech Duration
|
129 seconds
Standard Deviation 52
|
141 seconds
Standard Deviation 65
|
PRIMARY outcome
Timeframe: follow-up, one month after baseline assessmentPopulation: Completer only (no imputation).
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.\*\*\*
Outcome measures
| Measure |
Anodal tDCS During Exposure
n=14 Participants
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
|
Sham tDCS During Exposure
n=12 Participants
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
|
|---|---|---|
|
BAT: Matched Audience, Anticipated Anxiety
|
39 units on a scale
Standard Deviation 19
|
38 units on a scale
Standard Deviation 25
|
PRIMARY outcome
Timeframe: follow-up, one month after baseline assessmentPopulation: completers only (no imputation).
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.\*\*\*
Outcome measures
| Measure |
Anodal tDCS During Exposure
n=14 Participants
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
|
Sham tDCS During Exposure
n=12 Participants
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
|
|---|---|---|
|
BAT: Matched Audience, Peak Anxiety
|
36 units on a scale
Standard Deviation 21
|
26 units on a scale
Standard Deviation 27
|
PRIMARY outcome
Timeframe: follow-up, one month after baseline assessmentPopulation: completers only (no imputation).
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.\*\*\*
Outcome measures
| Measure |
Anodal tDCS During Exposure
n=14 Participants
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
|
Sham tDCS During Exposure
n=12 Participants
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
|
|---|---|---|
|
BAT: Unmatched Audience, Speech Duration
|
145 seconds
Standard Deviation 60
|
168 seconds
Standard Deviation 72
|
PRIMARY outcome
Timeframe: follow-up, one month after baseline assessmentPopulation: completers only (no imputation).
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.\*\*\*
Outcome measures
| Measure |
Anodal tDCS During Exposure
n=14 Participants
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
|
Sham tDCS During Exposure
n=12 Participants
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
|
|---|---|---|
|
BAT: Unmatched Audience, Anticipated Anxiety
|
43 units on a scale
Standard Deviation 21
|
40 units on a scale
Standard Deviation 25
|
PRIMARY outcome
Timeframe: follow-up, one month after baseline assessmentPopulation: completers only (no imputation).
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.\*\*\*
Outcome measures
| Measure |
Anodal tDCS During Exposure
n=14 Participants
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
|
Sham tDCS During Exposure
n=12 Participants
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
|
|---|---|---|
|
BAT: Unmatched Audience, Peak Anxiety
|
35 units on a scale
Standard Deviation 21
|
28 units on a scale
Standard Deviation 24
|
SECONDARY outcome
Timeframe: follow-up, one month after baseline assessmentPopulation: 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).
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.
Outcome measures
| Measure |
Anodal tDCS During Exposure
n=15 Participants
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
|
Sham tDCS During Exposure
n=13 Participants
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
|
|---|---|---|
|
Personal Report of Public Speaking Anxiety
|
133.47 score on a scale
Standard Deviation 16.69
|
131.15 score on a scale
Standard Deviation 17.87
|
SECONDARY outcome
Timeframe: follow-up, one month after baseline assessmentPopulation: 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).
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.
Outcome measures
| Measure |
Anodal tDCS During Exposure
n=15 Participants
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
|
Sham tDCS During Exposure
n=13 Participants
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
|
|---|---|---|
|
Positive Self Statements
|
11.13 score on a scale
Standard Deviation 5.14
|
10.69 score on a scale
Standard Deviation 4.57
|
SECONDARY outcome
Timeframe: follow-up, one month after baseline assessmentPopulation: 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).
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.
Outcome measures
| Measure |
Anodal tDCS During Exposure
n=15 Participants
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
|
Sham tDCS During Exposure
n=13 Participants
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
|
|---|---|---|
|
Negative Self Statements
|
12.33 score on a scale
Standard Deviation 6.95
|
11.77 score on a scale
Standard Deviation 6.83
|
Adverse Events
Anodal tDCS During Exposure
Sham tDCS During Exposure
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place