UniVRse: protocol for a pilot randomised controlled trial of virtual reality cognitive-behaviour therapy for students with social anxiety

BACKGROUND: Social anxiety is prevalent amongst university students. Cognitive-behaviour therapy (CBT), and graded exposure techniques in particular, is an effective intervention for social anxiety. However, there are a number of barriers preventing the delivery of CBT to students who are socially anxious. Delivering this intervention using virtual reality (VR) can address these implementation issues. We have co-developed with a group of students a VR-CBT intervention (UniVRse) specifically for members of this student group with social anxiety. METHODS/DESIGN: The present study is a pilot randomised controlled trial conducted in the United Kingdom of the UniVRse intervention compared to a wait-list control group. The aim of the trial is to determine whether a definitive trial is justified by assessing study recruitment, retention, and acceptability, as well as establishing the effect size on the co-primary outcomes for the definitive trial sample size calculation. We aim to recruit 90 socially anxious students-45 in each trial arm. The trial will adopt a mixed-methods approach. We will collect quantitative data at baseline (T0) and post-intervention 6 weeks later (T1). We will invite participants randomised to the intervention arm to complete a qualitative exit interview. DISCUSSION: The results of this pilot trial will be used to determine whether a definitive trial is justified, and to inform the refinement of the UniVRse programme and trial procedures. In the longer term, the UniVRse intervention has the potential to be an effective and accessible psychological intervention for students with social anxiety. TRIAL REGISTRATION: Clinicaltrials.gov, NCT05704868. Registered 30th January 2023.