Cognitive behavioral therapy with adaptive virtual reality exposure vs. cognitive behavioral therapy with in vivo exposure in the treatment of social anxiety disorder: A study protocol for a randomized controlled trial

Per Trads Ørskov, Mia Beck Lichtenstein, Mathias Torp Ernst, Iben Fasterholdt, Asge Frederik Matthiesen, Marco Scirea, Stephane Bouchard, Tonny Elmose Andersen, Per Trads Ørskov, Mia Beck Lichtenstein, Mathias Torp Ernst, Iben Fasterholdt, Asge Frederik Matthiesen, Marco Scirea, Stephane Bouchard, Tonny Elmose Andersen

Abstract

Background: Social anxiety disorder (SAD) has a high prevalence and an early onset with recovery taking decades to occur. Current evidence supports the efficacy of cognitive behavioral therapy (CBT) with virtual reality (VR) exposure. However, the evidence is based on a sparse number of studies with predominantly small sample sizes. There is a need for more trials investigating the optimal way of applying VR based exposure for SAD. In this trial, we will test the efficacy of CBT with adaptive VR exposure allowing adjustment of the exposure based on real-time monitoring of the participants's anxiety level.

Methods: The trial is a randomized controlled, assessor-blinded, parallel-group superiority trail. The study has two arms: (1) CBT including exposure in vivo (CBT-Exp), (2) CBT including exposure therapy using individually tailored VR-content and a system to track anxiety levels (CBT-ExpVR). Treatment is individual, manual-based and consists of 10 weekly sessions with a duration of 60 min. The study includes 90 participants diagnosed with SAD. Assessments are carried out pre-treatment, mid-treatment and at follow-up (6 and 12 months). The primary outcome is the mean score on the Social Interaction Anxiety Scale (SIAS) with the primary endpoint being post-treatment.

Discussion: The study adds to the existing knowledge by assessing the efficacy of CBT with adaptive VR exposure. The study has high methodological rigor using a randomized controlled trial with a large sample size that includes follow-up data and validated measures for social anxiety outcomes.

Clinical trial registration: ClinicalTrials.gov, identifier: NCT05302518.

Keywords: cognitive behavioral therapy; electrodermal activity; exposure; heart rate; machine learning; psychophysiological measurements; social anxiety; virtual reality.

Conflict of interest statement

SB is the president and owns equity in Cliniques et Dévelopment in Virtuo, which develops virtual environments, and conflicts of interest are managed according to Université du Québec en Outaouais conflict of interest policy. Cliniques et Dévelopment in Virtuo did not create the virtual environments use in this study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Ørskov, Lichtenstein, Ernst, Fasterholdt, Matthiesen, Scirea, Bouchard and Andersen.

Figures

Figure 1
Figure 1
Flowchart for inclusions, interventions, and assessments. 1SIAS, Social Interaction Anxiety Scale; 2MDI, Major Depression Inventory; 3SAD, Social Anxiety Disorder; 4GDPR, General Data Protection Regulation; 5PSE, Present State Examination.
Figure 2
Figure 2
Schedule of enrollment, interventions, and assessments. 1SIAS, Social Interaction Anxiety Scale; 2 LSAS-SR, Leibowitz Anxiety Scale-Self report version; 3FNE-B, Fear of Negative Evaluation-Brief version; 4MDI, Major Depression Inventory; 5AUDIT, Alcohol Use Disorders Identification Test; 6DUDIT, Drug Use Disorders Identification Test; 7WAI, Working Alliance Inventory; 8SUDS, Subjective Units of Distress Scale; 9SSQ, Simulator Sickness Questionnaire; 10SWEAT, Specific Work for Exposure Applied in Therapy.

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