Abstract / Summary
Abstract Schizophrenia spectrum disorders impact about 1% of people globally, with 70% experiencing auditory hallucinations, whereas 30% of them have persistent symptoms despite effective pharmacological treatment. The main objective of this study is to generate preliminary data on the potential efficacy of VR-based Avatar therapy in treating residual auditory hallucinations. By exploring its potential efficacy across different countries, this study aims to provide initial insights into strategies for integrating VR-based Avatar therapy into clinical practice while also conducting an exploratory trial-based assessment of its cost-effectiveness compared to the waitlist (treatment-as-usual). This is a multicentre, non-randomised, waitlist-controlled, single-group, pre-post design study, intended to inform future randomised controlled trials by providing implementation-related insights. The study involves 90 participants. After enrolment, all patients will first be placed on a three-month waiting list, followed by a subsequent three-month period during which they will participate in a total of seven individual VR-based Avatar therapy sessions. Patients’ conditions will be assessed at three measurement points (week 0, 12, and 24). The primary outcome of the study is the change in auditory verbal hallucinations, including their frequency, intensity, content, and the patient’s coping strategies. Secondary outcomes focus on evaluating changes in comorbid affective symptoms, as well as in functionality. Although Avatar therapy shows promise, few studies focus on its VR-assisted form, often with small sample sizes and limited cultural contexts. More research with larger, diverse populations is needed to confirm its effectiveness. Additionally, assessing the cost-effectiveness of VR-based Avatar therapy is crucial for its integration into clinical practice. The study was registered at ClinicalTrials.gov under the identifier NCT06505564 at 2024.07.19.