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Due to COVID-19 the study was intitially paused and eventually ended.
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Social anxiety disorder (SAD) is a prevalent mental health concern that impacts approximately 12% of the population. One mechanism thought to maintain SAD is avoidance of faces (i.e. avoidance of negative evaluative threat). However, research on attentional processes in SAD has been confined to paradigms presented on computer monitors. To investigate attentional processes in a more naturalistic way the investigators developed an immersive, 360º-video virtual reality environment using real actors, as part of a pilot study. Participants with a range of social anxiety symptoms (from none to severe) completed a 5-minute speech in this virtual reality environment while their eye movements were recorded. Results from the study showed that greater symptoms of social anxiety were associated with avoidance of looking at faces (i.e. fewer fixations on faces). While existing treatments for SAD are moderately effective, a large number of individuals do not experience meaningful reductions in their symptoms. The overarching goal of this project is inform future treatment research for SAD. The investigators will test a brief attention guidance intervention for SAD that specifically targets avoidance of faces as a potential mechanism maintaining the disorder. The proposed research will use the eye tracking hardware and naturalistic virtual reality environment from the pilot study. The investigators will also collect eye tracking data prior to the intervention in order to investigate potential heterogeneity in the attentional processes of SAD. The investigators will test the hypotheses that (a) the attention guidance intervention, compared to the control intervention, will result in a greater reduction in symptoms of social anxiety, and (b) this effect will be mediated by the number of fixations on faces during a brief public speaking challenge following the intervention. These results will provide causal evidence related to a hypothesized mechanism maintaining SAD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention guidance | Experimental | 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. |
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| Control intervention | Active Comparator | Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attention guidance | Behavioral | Explicitly guiding attention towards faces during public speaking exposures |
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| Measure | Description | Time Frame |
|---|---|---|
| Personal Report of Public Speaking Anxiety Scale Post-intervention | Questionnaire that assesses fear of public speaking Score range (total summed score): 34-170; Higher score reflects greater public speaking anxiety | Immediately following the end of the 1-week intervention |
| Personal Report of Public Speaking Anxiety Scale at 1-week | Questionnaire that assesses fear of public speaking Score range: 34-170 (total summed score); Higher score reflects greater public speaking anxiety | 1-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Leibowitz Social Anxiety Scale Post-intervention | Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety | Immediately following the end of the 1-week intervention |
| Leibowitz Social Anxiety Scale at 1-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas at Austin | Austin | Texas | 78712 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control Intervention | Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
Control intervention: Public speaking exposures |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Post-treatment Assessment |
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| 1-week Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Personal Report of Public Speaking Anxiety Scale Post-intervention | Questionnaire that assesses fear of public speaking Score range (total summed score): 34-170; Higher score reflects greater public speaking anxiety | Posted | Mean | Standard Deviation | score on a scale | Immediately following the end of the 1-week intervention |
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Until study completion (approximately 2 weeks after the baseline assessment).
The intervention was behavioral and well established to pose no risks.
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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 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Telch | The University of Texas at Austin | 512-560-4100 | telch@austin.utexas.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 18, 2020 | Nov 3, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2021 | Dec 28, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2020 | Nov 3, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Control intervention | Behavioral | Public speaking exposures |
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Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety |
| 1-week follow-up |
| Speech Anxiety Thoughts Inventory Post-intervention | Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity | Immediately following the end of the 1-week intervention |
| Speech Anxiety Thoughts Inventory at 1-week | Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity | 1-week follow-up |
| NOT COMPLETED |
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| BG001 | Control Intervention | Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
Control intervention: Public speaking exposures |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Personal Report of Public Speaking Anxiety | The range for the measure was 34-170, with higher values reflecting greater anxiety. | Mean | Standard Deviation | score on a scale |
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| Liebowitz Social Anxiety Scale Self Report Version | The range for the measure was 0-144, with higher values reflecting greater anxiety. | Mean | Standard Deviation | score on a scale |
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| OG001 | Control Intervention | Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
Control intervention: Public speaking exposures |
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| Primary | Personal Report of Public Speaking Anxiety Scale at 1-week | Questionnaire that assesses fear of public speaking Score range: 34-170 (total summed score); Higher score reflects greater public speaking anxiety | Posted | Mean | Standard Deviation | score on a scale | 1-week follow-up |
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| Secondary | Leibowitz Social Anxiety Scale Post-intervention | Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety | Posted | Mean | Standard Deviation | score on a scale | Immediately following the end of the 1-week intervention |
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| Secondary | Leibowitz Social Anxiety Scale at 1-week | Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety | Posted | Mean | Standard Deviation | score on a scale | 1-week follow-up |
|
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| Secondary | Speech Anxiety Thoughts Inventory Post-intervention | Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity | Posted | Mean | Standard Deviation | score on a scale | Immediately following the end of the 1-week intervention |
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| Secondary | Speech Anxiety Thoughts Inventory at 1-week | Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity | Posted | Mean | Standard Deviation | score on a scale | 1-week follow-up |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Control Intervention | Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
Control intervention: Public speaking exposures | 0 | 10 | 0 | 10 | 0 | 10 |
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