IntroductionMany patients with psychosis experience everyday social situations as anxiety-provoking. The fears can arise, for example, from paranoia, hallucinations, social anxiety or negative-self beliefs. The fears lead patients to withdraw from activities, and this isolation leads to a cycle of worsening physical and mental health. Breaking this cycle requires highly active treatment directly in the troubling situations so that patients learn that they can safely and confidently enter them. However patients with psychosis seldom receive such life-changing interventions. To solve this problem we have developed an automated psychological treatment delivered in virtual reality (VR). It allows patients to experience computer simulations of the situations that they find anxiety-provoking. A virtual coach guides patients, using cognitive techniques, in how to overcome their fears. Patients are willing to enter VR simulations of anxiety-provoking situations because they know the simulations are not real, but the learning made transfers to the real world.Methods and analysis432 patients with psychosis and anxious avoidance of social situations will be recruited from National Health Service (NHS) secondary care services. In the gameChange trial, they will be randomised (1:1) to the six-session VR cognitive treatment added to treatment as usual or treatment as usual alone. Assessments will be conducted at 0, 6 (post-treatment) and 26 weeks by a researcher blind to allocation. The primary outcome is avoidance and distress in real-life situations, using a behavioural assessment task, at 6 weeks. The secondary outcomes are psychiatric symptoms, activity levels and quality of life. All main analyses will be intention-to-treat. Moderation and mediation will be tested. An economic evaluation will be conducted.Ethics and disseminationThe trial has received ethical approval from the NHS South Central - Oxford B Research Ethics Committee (19/SC/0075). A key output will be a high-quality automated VR treatment for patients to overcome anxious avoidance of social situations.Trial registration numberISRCTN17308399.
Background Many people with psychosis experience difficulties in everyday social situations. Anxiety can make life challenging, leading to withdrawal. Cognitive therapy, using active in vivo learning, enables people to overcome fears. These treatments are not readily available to people with psychosis. Automated virtual reality (VR) therapy is a potential route to increase accessibility. The gameChange automated VR cognitive therapy is designed to help people overcome anxious avoidance and build confidence in everyday social situations. A virtual coach guides the person through the treatment. Understanding user experience is key to facilitating future implementation. Peer research methods, in which people with lived experience of the issues being studied are involved in collecting and analyzing data, may be useful in developing this understanding. This encourages researchers to draw on their lived experience to explore participant perspectives and co-create knowledge. Objective The primary objective is to use a peer research approach to explore the participant experience of a novel automated VR therapy for anxious social avoidance. This includes understanding (1) the experience of anxious social avoidance in people with psychosis, (2) the experience of the gameChange automated VR cognitive therapy, and (3) any potential impact of the therapy in people’s lives. This will inform future implementation strategies. The secondary objective is to explore how peer research can be used to co-create knowledge. Methods Semistructured interviews will be conducted with approximately 25 people with psychosis participating in the gameChange trial (ISRCTN17308399). Participants will be recruited from the five trial centers based in National Health Service mental health trusts across England. Interviews will be conducted by two researchers. One is a peer researcher with similar lived experience to the trial participants. The other has lived experiences of mental health issues that do not directly overlap with those of the trial participants. Interview questions will focus on an individual’s experience of anxious social avoidance, experiences of participating in the gameChange VR therapy, and any changes or impact following therapy. The interview schedule was developed in collaboration with the gameChange Lived Experience Advisory Panel (LEAP), comprising 10 project advisors with lived experience of psychosis. Interpretative phenomenological analysis and template analysis will be used to explore individual accounts. The LEAP will contribute to the analysis. Results Data collection will be conducted from April to September 2021, and analysis will be conducted from June to October 2021. As of September 28, 2021, 20 participants had been interviewed, and coding is underway. Conclusions The study, employing a peer research approach, may provide a unique insight into the experiences of anxious social avoidance in people with psychosis and its treatment using automated VR therapy. This will inform potential future implementation of VR automated therapies in mental health services. International Registered Report Identifier (IRRID) DERR1-10.2196/31742
BACKGROUND Many people with psychosis struggle in everyday social situations. Anxiety can make life challenging, leading to withdrawal. Cognitive therapy, using active in-vivo learning, enables people to overcome fears. Yet these treatments are not readily available to people with psychosis. Automated virtual reality (VR) therapy may be one route to increase accessibility. The gameChange automated VR cognitive therapy is designed to help people overcome anxious avoidance and build confidence in everyday social situations (such as visiting a café or taking a bus). A virtual coach guides the person through the treatment. Understanding user experience will be key to facilitating future implementation. Peer-research methods, where people with lived experience of issues being studied are involved in collecting and analysing the data, may be useful in developing this understanding. This approach encourages researchers to draw on their lived experience to explore participant perspectives and co-create knowledge. OBJECTIVE The primary objective of this study is to use a peer-research approach to explore the participant experience of a novel automated VR therapy for anxious social avoidance. This includes understanding 1) the experience of anxious social avoidance in people with psychosis, 2) the experience of the gameChange automated VR cognitive therapy, and 3) any potential impact of the therapy in peoples’ lives. This will inform future implementation strategies. The secondary objective is to explore how peer research can be used to co-create knowledge. METHODS Semi-structured interviews will be conducted with approximately 25 people with psychosis who are participating in the gameChange trial (ISRCTN17308399). Participants will be recruited from the five trial centres based in NHS mental health Trusts across England. Interviews will be conducted by two researchers. One is a peer-researcher with similar lived experience of mental health to the trial participants. The other has lived experience of mental health issues that do not directly overlap with those of the trial participants. Interview questions will focus on an individual’s experience of anxious social avoidance, the experience of participating in the gameChange VR therapy, and any changes or impact following the therapy. The interview schedule was developed in collaboration with the gameChange Lived Experience Advisory Panel (LEAP); a group of ten project advisors with lived experience of psychosis. Interpretative Phenomenological Analysis and Template Analysis will be used to explore individual accounts as well as convergence and divergence across the sample. The LEAP will contribute to the analysis. RESULTS Data collection will be conducted April - August 2021, analysis conducted June – October 2021. CONCLUSIONS The study, employing a peer-research approach, may provide a unique insight into experiences of anxious social avoidance in people with psychosis and its treatment using automated VR therapy. This will inform potential future implementation of VR automated therapies in mental health services.
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