Trial Outcomes & Findings for Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder (NCT NCT03683823)
NCT ID: NCT03683823
Last Updated: 2022-03-11
Results Overview
Questionnaire that assesses fear of public speaking Score range (total summed score): 34-170; Higher score reflects greater public speaking anxiety
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Immediately following the end of the 1-week intervention
Results posted on
2022-03-11
Participant Flow
Participant milestones
| Measure |
Attention Guidance
In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.
Attention guidance: Explicitly guiding attention towards faces during public speaking exposures
|
Control Intervention
Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
1. On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.
2. Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.
3. Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.
4. Between speeches participants will have a 1-minute break.
Control intervention: Public speaking exposures
|
|---|---|---|
|
Post-treatment Assessment
STARTED
|
11
|
10
|
|
Post-treatment Assessment
COMPLETED
|
10
|
8
|
|
Post-treatment Assessment
NOT COMPLETED
|
1
|
2
|
|
1-week Follow-up
STARTED
|
10
|
8
|
|
1-week Follow-up
COMPLETED
|
9
|
7
|
|
1-week Follow-up
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Attention Guidance
In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.
Attention guidance: Explicitly guiding attention towards faces during public speaking exposures
|
Control Intervention
Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
1. On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.
2. Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.
3. Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.
4. Between speeches participants will have a 1-minute break.
Control intervention: Public speaking exposures
|
|---|---|---|
|
Post-treatment Assessment
Withdrawal by Subject
|
1
|
1
|
|
Post-treatment Assessment
Lost to Follow-up
|
0
|
1
|
|
1-week Follow-up
Research halted due to COVID-19 pandemic
|
1
|
1
|
Baseline Characteristics
Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Attention Guidance
n=11 Participants
In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.
Attention guidance: Explicitly guiding attention towards faces during public speaking exposures
|
Control Intervention
n=10 Participants
Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
1. On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.
2. Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.
3. Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.
4. Between speeches participants will have a 1-minute break.
Control intervention: Public speaking exposures
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
19.20 years
STANDARD_DEVIATION 1.23 • n=5 Participants
|
25.90 years
STANDARD_DEVIATION 15.42 • n=7 Participants
|
22.55 years
STANDARD_DEVIATION 8.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Personal Report of Public Speaking Anxiety
|
140.27 score on a scale
STANDARD_DEVIATION 16.85 • n=5 Participants
|
139.40 score on a scale
STANDARD_DEVIATION 14.30 • n=7 Participants
|
139.84 score on a scale
STANDARD_DEVIATION 15.58 • n=5 Participants
|
|
Liebowitz Social Anxiety Scale Self Report Version
|
75.27 score on a scale
STANDARD_DEVIATION 22.32 • n=5 Participants
|
79.70 score on a scale
STANDARD_DEVIATION 25.64 • n=7 Participants
|
77.49 score on a scale
STANDARD_DEVIATION 23.98 • n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately following the end of the 1-week interventionQuestionnaire that assesses fear of public speaking Score range (total summed score): 34-170; Higher score reflects greater public speaking anxiety
Outcome measures
| Measure |
Attention Guidance
n=10 Participants
In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.
Attention guidance: Explicitly guiding attention towards faces during public speaking exposures
|
Control Intervention
n=8 Participants
Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
1. On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.
2. Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.
3. Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.
4. Between speeches participants will have a 1-minute break.
Control intervention: Public speaking exposures
|
|---|---|---|
|
Personal Report of Public Speaking Anxiety Scale Post-intervention
|
123.50 score on a scale
Standard Deviation 21.21
|
119.63 score on a scale
Standard Deviation 19.54
|
PRIMARY outcome
Timeframe: 1-week follow-upQuestionnaire that assesses fear of public speaking Score range: 34-170 (total summed score); Higher score reflects greater public speaking anxiety
Outcome measures
| Measure |
Attention Guidance
n=9 Participants
In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.
Attention guidance: Explicitly guiding attention towards faces during public speaking exposures
|
Control Intervention
n=7 Participants
Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
1. On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.
2. Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.
3. Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.
4. Between speeches participants will have a 1-minute break.
Control intervention: Public speaking exposures
|
|---|---|---|
|
Personal Report of Public Speaking Anxiety Scale at 1-week
|
123.56 score on a scale
Standard Deviation 18.98
|
123.71 score on a scale
Standard Deviation 17.01
|
SECONDARY outcome
Timeframe: Immediately following the end of the 1-week interventionQuestionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety
Outcome measures
| Measure |
Attention Guidance
n=10 Participants
In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.
Attention guidance: Explicitly guiding attention towards faces during public speaking exposures
|
Control Intervention
n=8 Participants
Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
1. On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.
2. Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.
3. Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.
4. Between speeches participants will have a 1-minute break.
Control intervention: Public speaking exposures
|
|---|---|---|
|
Leibowitz Social Anxiety Scale Post-intervention
|
64.80 score on a scale
Standard Deviation 21.29
|
65.88 score on a scale
Standard Deviation 27.27
|
SECONDARY outcome
Timeframe: 1-week follow-upQuestionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety
Outcome measures
| Measure |
Attention Guidance
n=9 Participants
In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.
Attention guidance: Explicitly guiding attention towards faces during public speaking exposures
|
Control Intervention
n=7 Participants
Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
1. On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.
2. Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.
3. Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.
4. Between speeches participants will have a 1-minute break.
Control intervention: Public speaking exposures
|
|---|---|---|
|
Leibowitz Social Anxiety Scale at 1-week
|
51.89 score on a scale
Standard Deviation 28.18
|
55.57 score on a scale
Standard Deviation 15.08
|
SECONDARY outcome
Timeframe: Immediately following the end of the 1-week interventionAssesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity
Outcome measures
| Measure |
Attention Guidance
n=10 Participants
In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.
Attention guidance: Explicitly guiding attention towards faces during public speaking exposures
|
Control Intervention
n=8 Participants
Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
1. On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.
2. Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.
3. Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.
4. Between speeches participants will have a 1-minute break.
Control intervention: Public speaking exposures
|
|---|---|---|
|
Speech Anxiety Thoughts Inventory Post-intervention
|
73.80 score on a scale
Standard Deviation 22.11
|
70.12 score on a scale
Standard Deviation 19.69
|
SECONDARY outcome
Timeframe: 1-week follow-upAssesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity
Outcome measures
| Measure |
Attention Guidance
n=9 Participants
In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.
Attention guidance: Explicitly guiding attention towards faces during public speaking exposures
|
Control Intervention
n=7 Participants
Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
1. On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.
2. Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.
3. Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.
4. Between speeches participants will have a 1-minute break.
Control intervention: Public speaking exposures
|
|---|---|---|
|
Speech Anxiety Thoughts Inventory at 1-week
|
64.22 score on a scale
Standard Deviation 20.45
|
60.43 score on a scale
Standard Deviation 18.30
|
Adverse Events
Attention Guidance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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