Automated virtual reality (VR) cognitive therapy for patients with psychosis who have anxious avoidance of social situations: a single-blind parallel group randomised controlled trial (gameChange)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 346
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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)