NCT03683823

Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder

Terminated NA Results posted Last updated 11 March 2022

What this trial tests

NA trial testing Attention guidance in Social Anxiety Disorder in 21 participants. Terminated before completion.

Timeline

1 February 2019

Primary endpoint
11 March 2020

25 March 2020

Quick facts

Lead sponsor	University of Texas at Austin
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	1 February 2019
Primary completion	11 March 2020
Estimated completion	25 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Attention guidance
• Control intervention — full drug profile →

Conditions studied

• Social Anxiety Disorder — all drugs for Social Anxiety Disorder →

Sponsor

University of Texas at Austin

Who can join

Adults 18 to 65, any sex, with Social Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Personal Report of Public Speaking Anxiety Scale Post-intervention Primary · 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

Group	Value	95% CI
Attention Guidance	123.50	± 21.21
Control Intervention	119.63	± 19.54

Personal Report of Public Speaking Anxiety Scale at 1-week Primary · 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

Group	Value	95% CI
Attention Guidance	123.56	± 18.98
Control Intervention	123.71	± 17.01

Leibowitz Social Anxiety Scale Post-intervention Secondary · 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

Group	Value	95% CI
Attention Guidance	64.80	± 21.29
Control Intervention	65.88	± 27.27

Leibowitz Social Anxiety Scale at 1-week Secondary · 1-week follow-up

Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety

Group	Value	95% CI
Attention Guidance	51.89	± 28.18
Control Intervention	55.57	± 15.08

Speech Anxiety Thoughts Inventory Post-intervention Secondary · 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

Group	Value	95% CI
Attention Guidance	73.80	± 22.11
Control Intervention	70.12	± 19.69

Speech Anxiety Thoughts Inventory at 1-week Secondary · 1-week follow-up

Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity

Group	Value	95% CI
Attention Guidance	64.22	± 20.45
Control Intervention	60.43	± 18.30

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Attention guidance augmentation of virtual reality exposure therapy for social anxiety disorder: a pilot randomized controlled trial.
   Rubin M, Muller K, Hayhoe MM, Telch MJ. · · 2022 · cited 14× · PMID 35383544 · DOI 10.1080/16506073.2022.2053882