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

Abstract

IntroductionAlcohol 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 analysisThis 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 disseminationApproval 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 numberClinicalTrial.gov,NCT05042180.

Virtual reality-assisted cognitive behavioral therapy for patients with alcohol use disorder: a randomized feasibility study

“…Finally, previous studies investigating the efficacy of VR exposure in AUD-diagnosed patients have primarily evaluated changes in cue-reactivity ( 25 ). Therefore, we designed and conducted the present feasibility study as a predecessor to a larger randomized clinical trial investigating the long-term effect of VR exposure on alcohol consumption as the primary outcome ( 28 ). Thus, the data presented in the present study are preliminary and highlight the feasibility of the novel intervention, the equipment (head-mounted devices), treatment manuals, questionnaires, safety, attrition, and the ability of VR environments to induce therapeutically relevant reactions.…”

“…The treatment efficacy will be evaluated quantitatively (craving and alcohol consumption) and qualitatively (patients and therapists) up to 12 months after inclusion. To ensure homogeneity between the two study arms we have included electronic randomization using stratification for alcohol consumption, age, and gender ( 28 ). In conclusion, we have demonstrated VR-CBT to be a feasible intervention for patients with AUD, and the preliminary findings support further investigation of the efficacy of VR-CBT in patients with AUD using RCT and other rigorous methodology.…”

“…The present study precedes a clinical RCT investigating the efficacy of VR-CBT in patients with AUD ( 28 ). Based on Ghiţă et al.…”

GABAergic signaling in alcohol use disorder and withdrawal: pathological involvement and therapeutic potential

“…It is one of the most studied forms of treatment for SUD and has the most support from evidence-based studies. Adults with problematic drinking who received CBT showed decreased alcohol consumption, and newer variants of CBT, such as virtual reality-assisted CBT (Thaysen-Petersen et al, 2023), appear to be more successful than traditional methods (Carroll and Kiluk, 2017).…”