None listed
Conditions
Brief summary
To test the efficacy of a second version of a new virtual reality intervention that was designed to support the social and cognitive recovery of young people with psychosis. This second version was designed alongside young people with lived experience of psychosis and social challenges, and the purpose of this study is to compare version 1 to version 2 of this intervention, to determine the differences in efficacy. The study team hypothesize that version 2 of the intervention will be more effective at improving social functioning compared to the first version at a follow up interview six months after the delivery of the intervention.
Interventions
The proposed intervention is an exposure-based cognitive behavioural therapy adapted for delivery via virtual reality to support social functioning and social cognition in young people recovering from psychosis. The interventional condition within the study is the second version (VR-CBT 2.0) of a previously designed version that has been piloted with young people in a previous related project. In this project, six youth advisors aged 16-30 with lived experience of psychotic symptoms and social c
The proposed intervention is an exposure-based cognitive behavioural therapy adapted for delivery via virtual reality to support social functioning and social cognition in young people recovering from psychosis. The interventional condition within the study is the second version (VR-CBT 2.0) of a previously designed version that has been piloted with young people in a previous related project. In this project, six youth advisors aged 16-30 with lived experience of psychotic symptoms and social challenges were recruited to participate in six online group workshops (2 hours each) and one individual session (14 hours total) over six months. VR-CBT 2.0 will be developed following a user centred design process with a group of lived experience experts as an enhancement to our original version. As part of the intervention, participants will be offered 12 sessions (60 minutes), up to 2 per week, over a maximum of 3-months post baseline. VR-CBT 2.0 will include social cognitive interventions embedded in virtual social environments targeting all four key social cognition domains (1) Emotion recognition (2) Theory of mind, (3) Social perception/knowledge and (4) Attributional biases. VR-CBT 1.0 & 2.0 will be delivered via virtual reality where the participant will wear the VR headset while the VR clinician will speak to them through the headset and voice some of the avatars within the virtual environment to support young people in developing their social and cognitive functioning skills. Meta Quest 2 headsets will be used to deliver the intervention. The clinical intervention will be administered in one-on-one face-to-face appointments lasting 1-hour. Clinical psychologists who have been trained in delivering the intervention via virtual reality will administer the clinical intervention.
Sponsors
Orygen
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
14 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
To be considered eligible, a young person must: 1. Meet threshold diagnostic criteria for first episode psychosis (FEP) (defined within DSM-5 all psychotic spectrum disorders or affective disorder with psychotic features who are within their first year of treatment for psychosis) or ultra-high risk for psychosis (UHR) (as assessed by the Comprehensive Assessment of At-Risk Mental State (CAARMS56). Note: this assessment will be conducted by clinicians at the referring clinic and will not form part of the research assessment schedule. 2. Be aged 14 – 30 years 3. Be receiving care from an early psychosis service at the time of recruitment in Melbourne, Adelaide or Perth 4. Have a Social and Occupational Functioning Assessment Scale (SOFAS) score <751 Service providers will be considered eligible for inclusion in this study if they: 1. Work at a participating study site, AND 2. Are responsible for delivering VR-CBT as part of the trial, OR 3, Are responsible for leading a team and or managing the service.
Exclusion criteria
Young people will not be eligible for participation in this study if any of the below criteria are met: 1. They have cognitive impairment significant enough to impede participation in the study, as determined by treating clinician 2. They have insufficient command of the English language 3. They are currently an inpatient in an acute mental health ward 4. They have current active suicidal plans, with severe and imminent risk to their safety
Outcome results
None listed