Automated virtual reality (VR) cognitive therapy for patients with psychosis: study protocol for a single-blind parallel group randomised controlled trial (gameChange)
Susan Brown,
Chris Hollis,
John R Geddes,
Daniel Freeman,
Ly-Mee Yu,
Thomas Kabir,
Jen Martin,
Michael Craven,
José Leal,
Sinéad Lambe,
Anthony Morrison,
Kate Chapman,
Robert Dudley,
Eileen O'Regan,
Aitor Rovira,
Andrew Goodsell,
Laina Rosebrock,
Aislinn Bergin,
Tillie L Cryer,
Dan Robotham,
Humma Andleeb,
David M Clark,
Felicity Waite
Affiliations
Susan Brown
National Institute of Health Research (NIHR) MindTech Med Tech Co-operative, Nottingham, UK
Chris Hollis
NIHR MindTech MedTech Cooperative and NIHR Nottingham Biomedical Research Centre, School of Medicine, Division of Psychiatry, University of Nottingham, Nottingham, UK
John R Geddes
Oxford Health NHS Foundation Trust, Oxford, UK
Daniel Freeman
1 Department of Experimental Psychology, University of Oxford, Oxford, UK
Ly-Mee Yu
Centre for Statistics in Medicine, University of Oxford, UK
Thomas Kabir
1 Department of Experimental Psychology, University of Oxford, Oxford, UK
Jen Martin
National Institute of Health Research (NIHR) MindTech Med Tech Co-operative, Nottingham, UK
Michael Craven
NIHR Nottingham Biomedical Research Centre, Nottingham, UK
José Leal
2University of Oxford, Nuffield Department of Population Health, Oxford, United Kingdom
Sinéad Lambe
Department of Psychiatry, University of Oxford, Oxford, UK
Anthony Morrison
Division of Psychology and Mental Health, University of Manchester, Manchester, UK
Kate Chapman
Avon and Wiltshire Mental Health Partnership (AWP) NHS Trust, Bath, UK
Robert Dudley
1 Research and Development, Cumbria Northumberland Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK
Eileen O'Regan
Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK
Aitor Rovira
Department of Experimental Psychology, University of Oxford, Oxford, UK
Andrew Goodsell
Department of Psychiatry, University of Oxford, Oxford, UK
Laina Rosebrock
NIHR Oxford Health Biomedical Research Centre, Oxford, UK
Aislinn Bergin
National Institute of Health Research (NIHR) MindTech Med Tech Co-operative, Nottingham, UK
Tillie L Cryer
The McPin Foundation, London, UK
Dan Robotham
The McPin Foundation, London, UK
Humma Andleeb
The McPin Foundation, London, UK
David M Clark
NIHR Oxford Health Biomedical Research Centre, Oxford, UK
Felicity Waite
1 Department of Experimental Psychology, University of Oxford, Oxford, UK
Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ISRCTN17308399.
