Last updated on May 2019

CBT Versus CBT Augmented With Virtual Reality Exposure for Social Anxiety Disorder.

Brief description of study

Background Social Anxiety Disorder has high lifetime prevalence, early onset and long duration or chronicity. Exposure therapy is considered as one of the most effective element in cognitive behavioural therapy but in vivo exposure can be difficult to access and control, and is sometimes rejected by patients because they consider it too aversive. The use of virtual reality allows exposure to challenging situations in an immersive, but also protected, flexible and controlled environment.

Aim The aim of the SO REAL-trial is to investigate the effect of cognitive behavioural therapy (CBT-In Vivo Exposure) versus cognitive behavioural therapy augmented with virtual reality exposure (CBT-Virtual Exposure) for patients diagnosed with social anxiety disorder.

Methods The design is an investigator initiated randomized, assessor-blinded, parallel group and superiority designed clinical trial. From the psychotherapeutic outpatient clinics at Mental Health Centre Copenhagen, 302 patients, diagnosed with social anxiety disorder, will be included. All patients will be offered a manual-based 14 week cognitive behavioural treatment program, including 8 sessions with exposure therapy. Patients will be centrally randomised with concealed allocation sequence to cognitive behavioural therapy augmented with virtual reality exposure or cognitive behavioural therapy.

Patients will be assessed at baseline, post treatment and at one-year follow-up by independent researchers blinded for treatment condition. The primary outcome will be social anxiety measured with Liebowitz Social Anxiety Scale. Secondary outcome measures will include depression, social functioning, and patient satisfaction. Exploratory outcomes will be substance and alcohol use, working alliance, quality of life.

Perspectives The SO REAL trial will be the hitherto largest trial investigating the use of virtual reality as augmentation of cognitive behavioural therapy and the results may guide future clinical treatment

Clinical Study Identifier: NCT03845101

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Recruitment Status: Open

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