Cognitive behavioural therapy augmented with virtual reality exposure for treatment of social anxiety: A randomised clinical trial

Abstract

Background Social Anxiety Disorder (SAD) has high lifetime prevalence, early onset and long duration or chronicity. Cognitive Behavioural Therapy (CBT) has best evidence for treatment effect and planned exposure is considered one of the most effective elements of CBT in SAD. However, in vivo exposure can be difficult to access and control and is sometimes rejected by patients because they expect it to be too aversive. The use of virtual reality allows exposure to challenging situations in an immersive, but also protected, flexible and controlled environment. Methods The design is an investigator initiated randomized, assessor-blinded, parallel group and superiority designed clinical trial. 302 patients diagnosed with social anxiety disorder, will be included from two psychotherapeutic outpatient clinics at Mental Health Center Copenhagen. All patients will be offered a manual-based 14-week CBT group program, including eight sessions of exposure therapy. Patients will be randomised with concealed allocation sequence to CBT augmented with virtual reality exposure or CBT. Patients will be assessed at baseline, post treatment and at one-year follow-up by researchers blinded for treatment condition. The primary outcome will be social anxiety measured with Liebowitz Social Anxiety Scale. Secondary outcome measures will be depression, social functioning, and patient satisfaction. Exploratory outcomes will be substance and alcohol use, working alliance and quality of life. Discussion The SO REAL trial will be the hitherto largest trial investigating the use of virtual reality as augmentation of CBT and the results may guide future clinical treatments. Trials registration The project was registered at clinicaltrials.gov on 02/19/2019 as NCT03845101. Can be found online at: https://clinicaltrials.gov/ct2/show/NCT03845101