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Automated virtual reality (VR) cognitive therapy for patients with psychosis: study protocol for a single-blind parallel group randomised controlled trial (gameChange)
  1. Daniel Freeman1,2,3,
  2. Ly-Mee Yu4,
  3. Thomas Kabir5,
  4. Jen Martin6,7,8,
  5. Michael Craven6,8,9,
  6. José Leal10,
  7. Sinéad Lambe1,2,3,
  8. Susan Brown6,7,8,
  9. Anthony Morrison11,12,
  10. Kate Chapman13,
  11. Robert Dudley14,15,
  12. Eileen O'Regan16,
  13. Aitor Rovira1,2,3,
  14. Andrew Goodsell1,2,3,
  15. Laina Rosebrock1,2,3,
  16. Aislinn Bergin6,7,8,
  17. Tillie L Cryer5,
  18. Dan Robotham5,
  19. Humma Andleeb5,
  20. John R Geddes1,2,3,
  21. Chris Hollis6,7,8,
  22. David M Clark2,3,17,
  23. Felicity Waite1,2,3
  1. 1Department of Psychiatry, University of Oxford, Oxford, UK
  2. 2Oxford Health NHS Foundation Trust, Oxford, UK
  3. 3NIHR Oxford Health Biomedical Research Centre, Oxford, UK
  4. 4Primary Care Clinical Trials Unit, Nuffield Department of Primary care Health Sciences, University of Oxford, Oxford, UK
  5. 5The McPin Foundation, London, UK
  6. 6National Institute of Health Research (NIHR) MindTech Med Tech Co-operative, Nottingham, UK
  7. 7Division of Psychiatry & Applied Psychology, School of Medicine, Institute of Mental Health, University of Nottingham, Nottingham, UK
  8. 8NIHR Nottingham Biomedical Research Centre, Nottingham, UK
  9. 9Bioengineering Reserch Group, Faculty of engineering, University of Nottingham, Nottingham, UK
  10. 10Nuffield Department of Population Health, University of Oxford, Oxford, UK
  11. 11Greater Manchester Mental Health Foundation Trust, Manchester, UK
  12. 12Division of Psychology and Mental Health, University of Manchester, Manchester, UK
  13. 13Avon and Wiltshire Mental Health Partnership (AWP) NHS Trust, Bath, UK
  14. 14Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK
  15. 15University of Newcastle, Newcastle upon Tyne, UK
  16. 16Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK
  17. 17Department of Experimental Psychology, University of Oxford, Oxford, UK
  1. Correspondence to Daniel Freeman; daniel.freeman{at}psych.ox.ac.uk

Abstract

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.

  • schizophrenia
  • psychosis
  • cognitive therapy
  • virtual reality
  • treatment

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Footnotes

  • Correction notice This article has been corrected since it was published. The affiliations have been updated.

  • Contributors DF is the chief investigator, conceived the project, had overall responsibility for the treatment design and the trial design and drafted the trial protocol. DMC, MC, JG, CH, TK, JM, JL, FW and L-MY contributed to the overall study design. FW, SL, TK, TLC and DMC contributed to the treatment design. TK, TLC, HA and DR have been responsible for PPI. JM, SB, MC, AB, HA, and DR have advised on treatment implementation. LM-Y is responsible for the statistical analysis. JL and MC are responsible for the health economic analysis. AR and AG contributed to the virtual reality programming and support of the hardware. SL and LR are co-ordinating the trial. The trial site leads are DF/FW (Oxford), AM (Manchester), RD (Newcastle), EO’R (Nottingham), KC (Bristol). All authors commented on the trial protocol.

  • Funding The trial is funded by the NHS National Institute for Health Research (NIHR) invention for innovation (i4i) programme (Project II-C7-0117-20001). It is also supported by the NIHR Oxford Health Biomedical Research Centre.

  • Competing interests DF is a founder and chief clinical officer of Oxford VR, a University of Oxford spin-out company, which has programmed the gameChange treatment, is a collaborator in the research, and will commercialise the treatment. DF holds equity in Oxford VR.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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