Clinical diagnosis of schizophrenia spectrum psychosis (F20-29) or an affective diagnosis with psychotic symptoms (F31.2, 31.5, 32.3, 33.3) (ICD-10, WHO, 2010)
Conditions
Interventions
Current interventions as of 31/03/2021:
Participants are randomised (1:1) to the automated VR cognitive treatment added to treatment as usual or treatment as usual.
The gameChange VR treatment is a
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 16 years or older 2. Attending a NHS mental health trust for the treatment of psychosis 3. Clinical diagnosis of schizophrenia spectrum psychosis (F20-29) or an affective diagnosis with psychotic symptoms (F31.2, 31.5, 32.3, 33.3) (ICD-10, WHO, 2010) 4. Having self-reported difficulties going outside their home primarily due to anxiety that they would like treated 5. Participant is willing and able to give informed consent for participation in the trial
Exclusion criteria
Exclusion criteria: 1. Unable to attempt an Oxford-Behavioural Assessment Task (O-BAT) (the primary outcome measure) at baseline (e.g. due to being unpermitted to leave a psychiatric ward) 2. Photosensitive epilepsy 3. Significant visual, auditory, or balance impairment 4. Current receipt of another intensive psychological therapy (or about to start it within the 6-week trial therapy window) 5. Insufficient comprehension of English 6. In forensic settings or Psychiatric Intensive Care Unit (PICU) 7. Organic syndrome 8. Primary diagnosis of alcohol or substance disorder or personality disorder 9. Significant learning disability 10. Current active suicidal plans (added 31/03/2021) When ethical approval was received on 03/09/2020 to restart the trial following the pause due to COVID-19, this was with a continuing recruitment suspension in place for participants who were at moderate or high risk for a severe course of COVID-19. From 16/02/2021 patients who were at moderate or high risk for a severe course of COVID-19 could join the trial if they had received the COVID-19 vaccine (subject to medical advice)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Because of the pandemic the researchers have not been able to administer the Oxford Behavioural Avoidance Task (O-BAT). They are replacing the O-BAT as the primary outcome measure with the self-report version, which is called the Oxford Agoraphobic Avoidance Scale (O-AS). (added 31/03/2021). Current primary outcome measure as of 31/03/2021: Avoidance and distress in real-life situations, measured using Oxford Agoraphobic Avoidance Scale (O-AS) at 0, 6 and 26 weeks (primary outcome timepoint 6 weeks) Previous primary outcome measure: Avoidance and distress in real-life situations, measured using Oxford - Behavioural Avoidance Task (O-BAT) at 0, 6 and 26 weeks (primary outcome timepoint 6 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anxious avoidance assessed with the AMI-A (Chambless et al., 1985) and the O-BAT (Freeman et al, 2016) at 0, 6, 26 weeks 2. Activity levels measured by actigraphy at 0, 6, 26 weeks 3. Personal recovery measured with the Questionnaire about the Process of Recovery (QPR) (Neil et al., 2009) at 0, 6, 26 weeks 4. Paranoia measured with the R-GPTS (Green et al, 2008; Freeman et al, in prep) at 0, 6, 26 weeks 5. Worries with paranoid content measured with the Paranoia Worries Questionnaire (Freeman et al, 2019) at 0, 6, 26 weeks 6. Depression measured with the PHQ-9 (Kroenke et al, 2001) at 0, 6, 26 weeks 7. Suicidal ideation measured with the Columbia Scale Severity Scale (Posner et al, 2011) at 0, 6, 26 weeks 8. Meaningful activity measured with the time-budget (Jolley et al, 2006) at 0, 6, 26 weeks 9. Quality of life measured with the EQ-5D-5L (http://www.euroqol.org/) and ReQol (Keetharuth et al, 2018) at 0, 6, 26 weeks 10. Health economics measured with the Client Service Receipt Inventory (Beecham and Knapp, 1992) at 0, 6, 26 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed