The gameChange trial: automated virtual reality therapy to help patients with psychosis feel more confident in everyday situations

Not Applicable

Completed

• Conditions: 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); self-reported difficulties going outside the home primarily due to anxiety; Mental and Behavioural Disorders; Schizophrenia, schizotypal and delusional disordersBipolar affective disorder, current episode manic with psychotic symptomsBipolar affective disorder, current episode severe depression with psychotic symptomsSevere depressive episode with psychotic symptomsRecurrent depressive disorder, current episode severe with psychotic symptoms

• Registration Number: ISRCTN17308399
• Lead Sponsor: niversity of Oxford

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31462489 protocol (added 30/08/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35395204/ (added 02/09/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36399379/ Economic analysis (added 21/11/2022) 2023 Results article in https://doi.org/10.2196/38065 Qualitative results (added 17/01/2023) 2021 Protocol article in https://doi.org/10.2196/31742 Automated Virtual Reality Cognitive Therapy for People With Psychosis: Protocol for a Qualitative Investigation Using Peer Research Methods (added 24/06/2024) 2020 Protocol article in https://doi.org/10.2196/20300 Virtual Reality Cognitive Therapy in Inpatient Psychiatric Wards: Protocol for a Qualitative Investigation of Staff and Patient Views Across Multiple National Health Service Sites (added 24/06/2024) 2022 Results article in https://doi.org/10.2196/20300 Agoraphobic avoidance in patients with psychosis: Severity and response to automated VR therapy in a secondary analysis of a randomised controlled clinical trial (added 24/06/2024) 2022 Results article in https://doi.org/10.1017/s0033291722001167 Virtual reality (VR) therapy for patients with psychosis: satisfaction and side effects (added 24/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-02
• Study Completion: 2021-11-30
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 346

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br><br>Current primary outcome measure as of 31/03/2021: <br>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)<br><br>Previous primary outcome measure:<br>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)