Automated Virtual Reality Cognitive Therapy for People With Psychosis: Protocol for a Qualitative Investigation Using Peer Research Methods.

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. 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. 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. 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. 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. DERR1-10.2196/31742.

Bond J ，Robotham D ，Kenny A ，Pinfold V ，Kabir T ，Andleeb H ，Larkin M ，Martin JL ，Brown S ，Bergin AD ，Petit A ，Rosebrock L ，Lambe S ，Freeman D ，Waite F ... -  《JMIR Research Protocols》

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy.

Automated virtual reality (VR) therapy has the potential to substantially increase access to evidence-based psychological treatments. The results of a multicenter randomized controlled trial showed that gameChange VR cognitive therapy reduces the agoraphobic avoidance of people diagnosed with psychosis, especially for those with severe avoidance. We set out to use a peer research approach to explore participants' experiences with gameChange VR therapy. This in-depth experiential exploration of user experience may inform the implementation in clinical services and future VR therapy development. Peer-led semistructured remote interviews were conducted with 20 people with a diagnosis of psychosis who had received gameChange as part of the clinical trial (ISRCTN17308399). Data were analyzed using interpretative phenomenological analysis and template analyses. A multiperspectival approach was taken to explore subgroups. Credibility checks were conducted with the study Lived Experience Advisory Panel. Participants reported the substantial impact of anxious avoidance on their lives before the VR intervention, leaving some of them housebound and isolated. Those who were struggling the most with agoraphobic avoidance expressed the most appreciation for, and gains from, the gameChange therapy. The VR scenarios provided "a place to practise." Immersion within the VR scenarios triggered anxiety, yet participants were able to observe this and respond in different ways than usual. The "security of knowing the VR scenarios are not real" created a safe place to learn about fears. The "balance of safety and anxiety" could be calibrated to the individual. The new learning made in VR was "taken into the real world" through practice and distilling key messages with support from the delivery staff member. Automated VR can provide a therapeutic simulation that allows people diagnosed with psychosis to learn and embed new ways of responding to the situations that challenge them. An important process in anxiety reduction is enabling the presentation of stimuli that induce the original anxious fears yet allow for learning of safety. In gameChange, the interaction of anxiety and safety could be calibrated to provide a safe place to learn about fears and build confidence. This navigation of therapeutic learning can be successfully managed by patients themselves in an automated therapy, with staff support, that provides users with personalized control. The clinical improvements for people with severe anxious avoidance, the positive experience of VR, and the maintenance of a sense of control are likely to facilitate implementation.

Bond J ，Kenny A ，Pinfold V ，Couperthwaite L ，gameChange Lived Experience Advisory Panel ，Kabir T ，Larkin M ，Beckley A ，Rosebrock L ，Lambe S ，Freeman D ，Waite F ，Robotham D ... -  《-》

Automated virtual reality (VR) cognitive therapy for patients with psychosis: study protocol for a single-blind parallel group randomised controlled trial (gameChange).

Many 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. 432 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. The 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. ISRCTN17308399.

Freeman D ，Yu LM ，Kabir T ，Martin J ，Craven M ，Leal J ，Lambe S ，Brown S ，Morrison A ，Chapman K ，Dudley R ，O'Regan E ，Rovira A ，Goodsell A ，Rosebrock L ，Bergin A ，Cryer TL ，Robotham D ，Andleeb H ，Geddes JR ，Hollis C ，Clark DM ，Waite F ... -  《BMJ Open》

Virtual Reality Cognitive Therapy in Inpatient Psychiatric Wards: Protocol for a Qualitative Investigation of Staff and Patient Views Across Multiple National Health Service Sites.

Patients in psychiatric wards typically have very limited access to individual psychological therapy. Inpatients often have significant time available, and an important transition back to everyday life to prepare for-but historically, there have been few trained therapists available on wards for the delivery of evidence-based therapy. Automated virtual reality (VR) therapy may be one route to increase the provision of powerful psychological treatments in psychiatric hospitals. The gameChange automated VR cognitive therapy is targeted at helping patients overcome anxious avoidance and re-engage in everyday situations (such as walking down the street, taking a bus, or going to a shop). This treatment target may fit well for many patients preparing for discharge. However, little is known about how VR therapy may be viewed in this setting. The objectives of the study are to explore psychiatric hospital staff and patients' initial expectations of VR therapy, to gather patient and staff views of an automated VR cognitive therapy (gameChange) after briefly experiencing it, and to identify potential differences across National Health Service (NHS) mental health trusts for implementation. Guided by an implementation framework, the knowledge gained from this study will be used to assess the feasibility of VR treatment adoption into psychiatric hospitals. Focus groups will be conducted with NHS staff and patients in acute psychiatric wards at 5 NHS mental health trusts across England. Staff and patients will be interviewed in separate groups. Individual interviews will also be conducted when preferred by a participant. Within each of the 5 trusts, 1 to 2 wards will be visited. A total of 8-15 staff and patients per ward will be recruited, with a minimum total of 50 staff and patients recruited across all sites. Focus group questions have been derived from the nonadoption, abandonment, and challenges to the scale-up, spread, and sustainability (NASSS) framework. Focus groups will discuss expectations of VR therapy before participants are given the opportunity to briefly try the gameChange VR therapy. Questions will then focus on opinions about the therapy and investigate feasibility of adoption, with particular consideration given to site specific issues. A thematic analysis will be conducted. As of May 15, 2020, 1 patient focus group has been conducted. The study will provide unique insight from patients and staff into the potential for implementing automated VR therapy in psychiatric wards. Perspectives will be captured both on the use of immersive technology hardware and therapy-specific issues in such settings. DERR1-10.2196/20300.

Brown P ，Waite F ，Lambe S ，Rosebrock L ，Freeman D ... -  《-》

Automated virtual reality therapy to treat agoraphobic avoidance and distress in patients with psychosis (gameChange): a multicentre, parallel-group, single-blind, randomised, controlled trial in England with mediation and moderation analyses.

Automated delivery of psychological therapy using immersive technologies such as virtual reality (VR) might greatly increase the availability of effective help for patients. We aimed to evaluate the efficacy of an automated VR cognitive therapy (gameChange) to treat avoidance and distress in patients with psychosis, and to analyse how and in whom it might work. We did a parallel-group, single-blind, randomised, controlled trial across nine National Health Service trusts in England. Eligible patients were aged 16 years or older, with a clinical diagnosis of a schizophrenia spectrum disorder or an affective diagnosis with psychotic symptoms, and had self-reported difficulties going outside due to anxiety. Patients were randomly assigned (1:1) to either gameChange VR therapy plus usual care or usual care alone, using a permuted blocks algorithm with randomly varying block size, stratified by study site and service type. gameChange VR therapy was provided in approximately six sessions over 6 weeks. Trial assessors were masked to group allocation. Outcomes were assessed at 0, 6 (primary endpoint), and 26 weeks after randomisation. The primary outcome was avoidance of, and distress in, everyday situations, assessed using the self-reported Oxford Agoraphobic Avoidance Scale (O-AS). Outcome analyses were done in the intention-to-treat population (ie, all participants who were assigned to a study group for whom data were available). We performed planned mediation and moderation analyses to test the effects of gameChange VR therapy when added to usual care. This trial is registered with the ISRCTN registry, 17308399. Between July 25, 2019, and May 7, 2021 (with a pause in recruitment from March 16, 2020, to Sept 14, 2020, due to COVID-19 pandemic restrictions), 551 patients were assessed for eligibility and 346 were enrolled. 231 (67%) patients were men and 111 (32%) were women, 294 (85%) were White, and the mean age was 37·2 years (SD 12·5). 174 patients were randomly assigned to the gameChange VR therapy group and 172 to the usual care alone group. Compared with the usual care alone group, the gameChange VR therapy group had significant reductions in agoraphobic avoidance (O-AS adjusted mean difference -0·47, 95% CI -0·88 to -0·06; n=320; Cohen's d -0·18; p=0·026) and distress (-4·33, -7·78 to -0·87; n=322; -0·26; p=0·014) at 6 weeks. Reductions in threat cognitions and within-situation defence behaviours mediated treatment outcomes. The greater the severity of anxious fears and avoidance, the greater the treatment benefits. There was no significant difference in the occurrence of serious adverse events between the gameChange VR therapy group (12 events in nine patients) and the usual care alone group (eight events in seven patients; p=0·37). Automated VR therapy led to significant reductions in anxious avoidance of, and distress in, everyday situations compared with usual care alone. The mediation analysis indicated that the VR therapy worked in accordance with the cognitive model by reducing anxious thoughts and associated protective behaviours. The moderation analysis indicated that the VR therapy particularly benefited patients with severe agoraphobic avoidance, such as not being able to leave the home unaccompanied. gameChange VR therapy has the potential to increase the provision of effective psychological therapy for psychosis, particularly for patients who find it difficult to leave their home, visit local amenities, or use public transport. National Institute of Health Research Invention for Innovation programme, National Institute of Health Research Oxford Health Biomedical Research Centre.

Freeman D ，Lambe S ，Kabir T ，Petit A ，Rosebrock L ，Yu LM ，Dudley R ，Chapman K ，Morrison A ，O'Regan E ，Aynsworth C ，Jones J ，Murphy E ，Powling R ，Galal U ，Grabey J ，Rovira A ，Martin J ，Hollis C ，Clark DM ，Waite F ，gameChange Trial Group ... -  《Lancet Psychiatry》