Ariane Beckley

Objectives: Treatments for patients diagnosed with psychosis need to be improved. Clinical trials are an important way of assessing the efficacy of new treatments. However, recruiting patients into trials is challenging. This study sought to better understand the reasons for this from the perspective of research assistants. Design: A qualitative study underpinned by a critical realist ontology and contextualist epistemology. Methods: Research assistants who had recruited patients with psychosis into trials, primarily of psychological interventions, were interviewed. Reflexive thematic analysis was used to identify themes. Results: Overarching themes representing four types of factors influencing recruitment of patients with psychosis into clinical trials were generated: patient, clinical team, research team, and NHS infrastructure. Patients largely wished to take part in trials but needed time to build trust with research assistants. Clinical teams held the power in suggesting patients for trials; therefore, it was essential for research teams to build strong relationships with clinical staff. Research teams recruiting into trials benefited from lived experience expertise, support systems, and institutional knowledge. A key NHS infrastructure factor was that mental health staff had limited time to consider trials for their patients. Conclusions: Trial participation needs to be made more accessible to patients with psychosis, who often want to take part but lack opportunities. Methods of increasing accessibility could include identifying and addressing barriers to referral from clinical teams, employing multiple recruitment strategies, and flexible appointment formats. Qualitative research with clinical teams and patients will also help in developing the understanding of barriers to recruitment.

Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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.

Background: An automated virtual reality cognitive therapy (gameChange) has demonstrated its effectiveness to treat agoraphobia in patients with psychosis, especially for high or severe anxious avoidance. Its economic value to the health care system is not yet established. Objective: In this study, we aimed to estimate the potential economic value of gameChange for the UK National Health Service (NHS) and establish the maximum cost-effective price per patient. Methods: Using data from a randomized controlled trial with 346 patients with psychosis (ISRCTN17308399), we estimated differences in health-related quality of life, health and social care costs, and wider societal costs for patients receiving virtual reality therapy in addition to treatment as usual compared with treatment as usual alone. The maximum cost-effective prices of gameChange were calculated based on UK cost-effectiveness thresholds. The sensitivity of the results to analytical assumptions was tested. Results: Patients allocated to gameChange reported higher quality-adjusted life years (0.008 QALYs, 95% CI –0.010 to 0.026) and lower NHS and social care costs (–£105, 95% CI –£1135 to £924) compared with treatment as usual (£1=US $1.28); however, these differences were not statistically significant. gameChange was estimated to be worth up to £341 per patient from an NHS and social care (NHS and personal social services) perspective or £1967 per patient from a wider societal perspective. In patients with high or severe anxious avoidance, maximum cost-effective prices rose to £877 and £3073 per patient from an NHS and personal social services perspective and societal perspective, respectively. Conclusions: gameChange is a promising, cost-effective intervention for the UK NHS and is particularly valuable for patients with high or severe anxious avoidance. This presents an opportunity to expand cost-effective psychological treatment coverage for a population with significant health needs. Trial Registration: ISRCTN Registry ISRCTN17308399; https://www.isrctn.com/ISRCTN17308399 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-031606