Virtual reality-assisted cognitive behavioural therapy for outpatients with alcohol use disorder (CRAVR):A protocol for a randomised controlled trial

Introduction Alcohol use disorder (AUD) is a brain disorder linked to over 200 health conditions. Cognitive behavioural therapy (CBT) is considered the best practice in the treatment of AUD, but more than 60% of patients relapse within the first year after treatment. Psychotherapy combined with virtual reality (VR) has received increasing interest in the treatment of AUD. However, existing studies have primarily investigated the use of VR for cue reactivity. We therefore aimed to investigate the effect of VR-assisted CBT (VR-CBT). Methods and analysis This study is an assessor-blinded, randomised clinical trial being conducted at three outpatient clinics in Denmark. We will randomise 102 patients to 14 individual sessions of either manualised VR-CBT or CBT. The VR-CBT group will receive exposure to immersive high-risk VR situations from a pub, bar/party, restaurant, supermarket and at-home (30 videos) to activate high-risk-related beliefs and cravings for subsequent modification using CBT techniques. The treatment period is 6 months, and follow-up visits will be performed 3, 6, 9 and 12 months after inclusion. The primary outcome measure is the change in total alcohol consumption from baseline to 6 months after inclusion, measured with the Timeline Followback Method. Key secondary outcome measures include changes in the number of heavy drinking days, alcohol cravings, cognition, and symptoms of depression and anxiety. Ethics and dissemination Approval has been obtained by the research ethics committee in the Capital Region of Denmark (H-20082136) and the Danish Data Protection Agency (P-2021-217). All patients will receive both oral and written information about the trial and written informed consent will be obtained from each patient before inclusion. The study results will be disseminated in peer-reviewed publications and conference presentations. Trial registration number ClinicalTrial.gov, NCT05042180.</p

Examination of gaze behaviour in social anxiety disorder using a virtual reality eye-tracking paradigm: protocol for a case–control study

Introduction Social anxiety disorder (SAD) has an early onset, a high lifetime prevalence, and may be a risk factor for developing other mental disorders. Gaze behaviour is considered an aberrant feature of SAD. Eye-tracking, a novel technology device, enables recording eye movements in real time, making it a direct and objective measure of gaze behaviour. Virtual reality (VR) is a promising tool for assessment and diagnostic purposes. Developing an objective screening tool based on examination of gaze behaviour in SAD may potentially aid early detection. The objective of this current study is, therefore to examine gaze behaviour in SAD utilising VR.Methods and analysis A case–control study design is employed in which a clinical sample of 29 individuals with SAD will be compared with a matched healthy control group of 29 individuals. In the VR-based eye-tracking paradigm, participants will be presented to stimuli consisting of high-res 360° 3D stereoscopic videos of three social-evaluative tasks designed to elicit social anxiety. The study will investigate between-group gaze behaviour differences during stimuli presentation.Ethics and dissemination The study has been approved by the National Committee on Health Research Ethics for the Capital Region of Denmark (H-22041443). The study has been preregistered on OSF registries: https://doi.org/10.17605/OSF.IO/XCTAKAll participants will be provided with written and oral information. Informed consent is required for all the participants. Participation is voluntarily, and the participants can at any time terminate their participation without any consequences. Study results; positive, negative or inconclusive will be published in relevant scientific journals