Social Anxiety DisorderNCT03683823
Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder
A study testing Attention guidance in people with Social Anxiety Disorder, run by University of Texas at Austin at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Attention guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 25 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65;
- Fluent in English;
- Personal Report of Public Speaking Anxiety score > 98;
- Leibowitz Social Anxiety Scale > 30;
- Peak fear ≥ 50 on the behavioral approach task during the baseline assessment;
- Meets DSM-5 Criteria for Social Anxiety Disorder.
Who cannot join
- Currently receiving CBT for Social Anxiety Disorder;
- Significant visual impairment precluding the use of virtual reality equipment;
- Unstable dose of psychotropic medications within 3 weeks prior to baseline assessment;
- Current alcohol or substance use disorders;
- Current, or history of bipolar disorder; current, or history of psychosis;
- Serious suicidal risk, as determined by clinical interview.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78712
About this study
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.
- Conditions
- Social Anxiety Disorder
- Being tested
- Attention guidance, Control intervention
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention guidanceBehavioural
Explicitly guiding attention towards faces during public speaking exposures
Control interventionBehavioural
Public speaking exposures
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Attention guidance |
| Control intervention | Active comparator | 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. Receives: Behavioral: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1-week follow-up
Secondary outcomes (4)
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
Measured: Immediately following the end of the 1-week intervention
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
Measured: 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
Measured: 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
Measured: 1-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Feb 2019
- Primary completion11 Mar 2020
- Study completion25 Mar 2020
Why it stopped: Due to COVID-19 the study was intitially paused and eventually ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Telch, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683823
- Sponsor's protocol ID
- 2018-04-0011
- Status last verified
- Dec 2021
- First submitted
- 20 Jul 2018
- Last updated
- 11 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT03683823
- Acronym / sponsor ID
- 2018-04-0011
- Conditions
- Social Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 the study was intitially paused and eventually ended.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Posted 11 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention guidance | Experimental | Behavioral: Attention guidanceIn 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. |
| Control intervention | Active comparator | Behavioral: Control interventionParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65;
- Fluent in English;
- Personal Report of Public Speaking Anxiety score > 98;
- Leibowitz Social Anxiety Scale > 30;
- Peak fear ≥ 50 on the behavioral approach task during the baseline assessment;
Key exclusion criteria (6 listed)
- Currently receiving CBT for Social Anxiety Disorder;
- Significant visual impairment precluding the use of virtual reality equipment;
- Unstable dose of psychotropic medications within 3 weeks prior to baseline assessment;
- Current alcohol or substance use disorders;
- Current, or history of bipolar disorder; current, or history of psychosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention guidanceExplicitly guiding attention towards faces during public speaking exposures | Behavioural | Attention guidance |
| Control interventionPublic speaking exposures | Behavioural | Control intervention |
Primary outcome
Personal Report of Public Speaking Anxiety Scale Post-intervention
Time frame: 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
Time frame: 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
4 secondary outcomes
Leibowitz Social Anxiety Scale Post-intervention
Time frame: Immediately following the end of the 1-week intervention
Leibowitz Social Anxiety Scale at 1-week
Time frame: 1-week follow-up
Speech Anxiety Thoughts Inventory Post-intervention
Time frame: Immediately following the end of the 1-week intervention
Speech Anxiety Thoughts Inventory at 1-week
Time frame: 1-week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention guidance in people with Social Anxiety Disorder, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Report of Public Speaking Anxiety Scale Post-intervention (time frame: Immediately following the end of the 1-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.