JMIR Publications

ABSTRACT

Background:

Current treatments for schizophrenia and other psychotic disorders have limited efficacy, with high rates of non-response to ‘gold standard’ treatments. New approaches are therefore urgently required. We have developed a new treatment approach for auditory verbal hallucinations (AVH), a major symptom of psychotic disorders. This treatment (‘Hybrid’) integrates advances in psychological therapy (cognitive-behaviour therapy for psychosis, CBTp), technology (virtual reality, VR) and neuroscience (EEG-based neurofeedback). Hybrid takes a ‘symptom capture’ approach using individually tailored VR-based exposure exercises. Participants are progressively exposed to symptom triggers in a controlled environment and develop methods of down regulating neural activity associated with these symptoms (neurofeedback component) while concurrently receiving clinician-delivered CBT for psychosis (CBTp) in-vivo (i.e., during symptom activation). The aims of the current pilot study are to: investigate the feasibility, acceptability, safety and usability of Hybrid treatment (primary aim); explore Hybrid’s treatment efficacy and engagement of treatment targets (secondary aims). The treatment targets are self-directed modulation of high-beta band (18-30 Hz) neurophysiological activity (neural target) and progressing upwards through a VR-based symptom-eliciting exposure hierarchy (psychological target). In this paper, we present the background and protocol of the pilot study.

Objective:

Primary aim: Investigate the feasibility, acceptability, safety and usability of Hybrid treatment in FEP patients. Secondary aims: Explore Hybrid’s treatment efficacy and engagement of treatment targets.

Methods:

We will conduct a pilot study of the Hybrid protocol with 10 first episode psychosis (FEP) patients who are currently experiencing AVH. Participants receive the intervention package weekly over 12 sessions. In each session, they are progressively exposed to increasing levels of symptom triggers in a controlled VR environment, while concurrently receiving clinician-delivered CBTp. The neurofeedback, which is integrated into the VR system and based on AVHs-related high-beta band activity, will be used by the FEP participants to downregulate their neural activity in real time, with the aim of enhancing the therapeutic effect and transferring these skills to everyday life.

Results:

As of June 2024, this feasibility pilot study recently started recruitment activities. No participants have been recruited yet. We anticipate results of the pilot study to be available towards the end of 2025.

Conclusions:

The Hybrid study is piloting a novel approach which has the potential to address the shortcomings of current treatments for psychotic symptoms. If there is favourable evidence for the acceptability, feasibility, safety and usability of Hybrid, the study team will move on to efficacy trials. Clinical Trial: ACTRN12624000136505