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Hybrid: Integrating Virtual Reality, Neurofeedback and Cognitive Behaviour Therapy for Treatment of Hearing Voices in Young People

Hybrid: Integrating Virtual Reality, Neurofeedback and Cognitive Behaviour Therapy for Treatment of Hearing Voices in Young People Experiencing Psychosis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000357550
Acronym
Hybrid
Enrollment
10
Registered
2024-03-28
Start date
2024-04-04
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The current study will investigate the potential of a novel treatment approach to AVH in young people with first episode psychosis. This integrative model combines advances in psychological therapy (CBT for psychosis), new technologies (Virtual Reality) and neuroscience (neurofeedback) in an individualised symptom capture treatment approach. The appellation ‘Hybrid’ is used to reflect this integrated approach of treatment. The focus is on the first episode of psychosis rather than on relapsing or chronic samples, as enhancing treatment in the early stages of disorder has been found to have the greatest impact on clinical outcomes. The targets of interest here are both neural (modulating specific neurophysiological activity, see below) and psychological (moving up a symptom-eliciting exposure hierarchy).

Interventions

Hybrid is a new, integrated approach for the treatment of auditory verbal hallucinations (AVH) in early psychosis that takes a ‘symptom capture’ approach using individually tailored virtual reality (VR)-based exposure exercises. Participants are progressively exposed to symptom triggers in a controlled VR environment and develop methods of down regulating neural activity associated with these symptoms (via neurofeedback) while concurrently receiving clinician-delivered CBT for psychosis (CBTp) i

Hybrid is a new, integrated approach for the treatment of auditory verbal hallucinations (AVH) in early psychosis that takes a ‘symptom capture’ approach using individually tailored virtual reality (VR)-based exposure exercises. Participants are progressively exposed to symptom triggers in a controlled VR environment and develop methods of down regulating neural activity associated with these symptoms (via neurofeedback) while concurrently receiving clinician-delivered CBT for psychosis (CBTp) in-vivo (i.e., during symptom activation). The study intervention consists of three elements delivered concurrently: 1. A VR exposure hierarchy to imitate real-world environments in which the participant has difficulty managing their AVH. Our approach is based within the CBTp framework and involves developing an understanding of the antecedents of hallucinatory experiences. The participant and therapist will then select a template scenario from pre-existing VR environments (e.g., supermarket, bedroom) where various aspects of the environment (such as the number of people, the proximity and gaze intensity of people, lighting, noise etc) can be personalised to create a hierarchy of symptom-provoking strategies. For each participant there will be five scaled variants of their personalised scenes which will be presented via a wearable VR headset. 2. Neurofeedback from electroencephalography (EEG) measurement. Specifically, neurofeedback of real-time EEG activity of high beta band activity will be presented to participants as a visual image of a thermometer in the corner of the VR headset. The participant will attempt to modulate neural activity associated with AVH. This will be visually represented by the thermometer reducing in temperature. 3. Cognitive-behaviour therapy with a clinician (member of research team) enhancing strategies for coping with symptoms. The Hybrid intervention will take place over 14 weeks at Orygen Ltd in Parkville, Melbourne, Australia, and consists of two phases: the Preparation and Implementation Phases. The Hybrid Preparation phase will occur over a 2-week period following screening and baseline assessments. The Preparation phase will involve participants working with a clinically trained research team member to develop the tailored VR exposure hierarchies. The Hybrid Implementation Phase will consist of 12 sessions of 30-45 minutes each spread over 12 weeks. Participants will start on the lowest level of their exposure hierarchy and progressively work up the hierarchy over the course of the weekly sessions. The standard approach in exposure and response prevention interventions will be adopted, which is to reduce subjective units of distress to 30/100 before progressing to the next step in the hierarchy. While the participant is exposed to the symptom-eliciting VR scenario, they will engage in CBTp with their therapist (using open-back earphones) where the CBT will be standard, manualised CBT for voices, dealing with the active cognitions elicited by the VR scenario. Key elements include reassurance regarding lack of threat, challenging appraisals of AVH (e.g., their perceived power, threat, or dominance; reducing submissive or reactive behaviours), actively responding to AVH, and developing a sense of control over AVH by attempting to delay or reduce their volume or distract from them with a variety of strategies (e.g., humming, visualisation). Furthermore, participants will also be instructed to use the neurofeedback to reduce their level of distress within the VR environment. Each VR scenario will be used multiple times until the participant is comfortable and can progress to the next level in the hierarchy. The Hybrid pilot intervention will be delivered in addition to standard care received in (Early Psychosis Prevention & Intervention Centre (EPPIC). We will monitor consent and completion rates; number of sessions attended; number of dropouts; completion rates of measures, and whether AVH were elicited in 80% or more of VR sessions. Furthermore, we will administer a semi-structured interview upon completion to gather information about participant’s experience of the intervention and suggestions for modifications to the treatment package.

Sponsors

Barnaby Nelson
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

1) Aged 15-25 years inclusive. 2) Sufficient fluency in English to engage in psychological therapy with an English-speaking therapist, and to understand the study assessments. 3) Ability to give informed consent and adhere to study procedures. Parental or guardian consent will be obtained for participants aged under 18 years. 4) Psychotic threshold AVH as measured by the Comprehensive Assessment of At Risk Mental States (CAARMS; 5 or 6 on severity and greater than or equal to 4 on frequency for longer than one week; Yung et al., 2005) 5) A current rating of greater than or equal to 3 on the Psychotic Symptom Rating Scales (PSYRATS) hallucinations scale (Drake, Haddock, Tarrier, Bentall, & Lewis, 2007), corresponding to voices occurring at least once/hour. The purpose of this is to ensure that participants with reasonably frequent hallucinations are included in the study, as experience of symptoms during Hybrid sessions will optimise the study’s test of outcomes of interest.

Exclusion criteria

Exclusion Criteria: 1) Documented history of head injury, seizures, or other significant neurological illness 2) Documented history of intellectual disability 3) Visual impairment precluding ability to view VR scenario

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026