Social Anxiety Disorder
Conditions
Brief summary
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.
Interventions
BEHAVIORALAttention guidance
Explicitly guiding attention towards faces during public speaking exposures
BEHAVIORALControl intervention
Public speaking exposures
Sponsors
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65; 2. Fluent in English; 3. Personal Report of Public Speaking Anxiety score \> 98; 4. Leibowitz Social Anxiety Scale \> 30; 5. Peak fear ≥ 50 on the behavioral approach task during the baseline assessment; 6. Meets DSM-5 Criteria for Social Anxiety Disorder.
Exclusion criteria
1. Currently receiving CBT for Social Anxiety Disorder; 2. Significant visual impairment precluding the use of virtual reality equipment; 3. Unstable dose of psychotropic medications within 3 weeks prior to baseline assessment; 4. Current alcohol or substance use disorders; 5. Current, or history of bipolar disorder; current, or history of psychosis; 6. Serious suicidal risk, as determined by clinical interview.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Personal Report of Public Speaking Anxiety Scale Post-intervention | Immediately following the end of the 1-week intervention | Questionnaire that assesses fear of public speaking Score range (total summed score): 34-170; Higher score reflects greater public speaking anxiety |
| Personal Report of Public Speaking Anxiety Scale at 1-week | 1-week follow-up | Questionnaire that assesses fear of public speaking Score range: 34-170 (total summed score); Higher score reflects greater public speaking anxiety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leibowitz Social Anxiety Scale Post-intervention | Immediately following the end of the 1-week intervention | Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety |
| Leibowitz Social Anxiety Scale at 1-week | 1-week follow-up | Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety |
| Speech Anxiety Thoughts Inventory Post-intervention | Immediately following the end of the 1-week intervention | Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity |
| Speech Anxiety Thoughts Inventory at 1-week | 1-week follow-up | Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| 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 | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1-week Follow-up | Research halted due to COVID-19 pandemic | 1 | 1 |
| Post-treatment Assessment | Lost to Follow-up | 0 | 1 |
| Post-treatment Assessment | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Control Intervention | Attention Guidance | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Continuous | 25.90 years STANDARD_DEVIATION 15.42 | 19.20 years STANDARD_DEVIATION 1.23 | 22.55 years STANDARD_DEVIATION 8.33 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Liebowitz Social Anxiety Scale Self Report Version | 79.70 score on a scale STANDARD_DEVIATION 25.64 | 75.27 score on a scale STANDARD_DEVIATION 22.32 | 77.49 score on a scale STANDARD_DEVIATION 23.98 |
| Personal Report of Public Speaking Anxiety | 139.40 score on a scale STANDARD_DEVIATION 14.3 | 140.27 score on a scale STANDARD_DEVIATION 16.85 | 139.84 score on a scale STANDARD_DEVIATION 15.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 8 Participants | 14 Participants |
| Region of Enrollment United States | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
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
Time frame: 1-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Guidance | Personal Report of Public Speaking Anxiety Scale at 1-week | 123.56 score on a scale | Standard Deviation 18.98 |
| Control Intervention | Personal Report of Public Speaking Anxiety Scale at 1-week | 123.71 score on a scale | Standard Deviation 17.01 |
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
Time frame: Immediately following the end of the 1-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Guidance | Personal Report of Public Speaking Anxiety Scale Post-intervention | 123.50 score on a scale | Standard Deviation 21.21 |
| Control Intervention | Personal Report of Public Speaking Anxiety Scale Post-intervention | 119.63 score on a scale | Standard Deviation 19.54 |
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
Time frame: 1-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Guidance | Leibowitz Social Anxiety Scale at 1-week | 51.89 score on a scale | Standard Deviation 28.18 |
| Control Intervention | Leibowitz Social Anxiety Scale at 1-week | 55.57 score on a scale | Standard Deviation 15.08 |
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
Time frame: Immediately following the end of the 1-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Guidance | Leibowitz Social Anxiety Scale Post-intervention | 64.80 score on a scale | Standard Deviation 21.29 |
| Control Intervention | Leibowitz Social Anxiety Scale Post-intervention | 65.88 score on a scale | Standard Deviation 27.27 |
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
Time frame: 1-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Guidance | Speech Anxiety Thoughts Inventory at 1-week | 64.22 score on a scale | Standard Deviation 20.45 |
| Control Intervention | Speech Anxiety Thoughts Inventory at 1-week | 60.43 score on a scale | Standard Deviation 18.3 |
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
Time frame: Immediately following the end of the 1-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Guidance | Speech Anxiety Thoughts Inventory Post-intervention | 73.80 score on a scale | Standard Deviation 22.11 |
| Control Intervention | Speech Anxiety Thoughts Inventory Post-intervention | 70.12 score on a scale | Standard Deviation 19.69 |