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

Abstract

Background: 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. Methods: 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. Findings: 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). Interpretation: 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. Funding: National Institute of Health Research Invention for Innovation programme, National Institute of Health Research Oxford Health Biomedical Research Centre.

Metadata

Item Type:	Article
Authors/Creators:	Freeman, Daniel Lambe, Sinéad Kabir, Thomas Petit, Ariane Rosebrock, Laina Yu, Ly Mee Dudley, Robert https://orcid.org/0000-0002-3765-9998 Chapman, Kate Morrison, Anthony O'Regan, Eileen Aynsworth, Charlotte Jones, Julia Murphy, Elizabeth Powling, Rosie Galal, Ushma Grabey, Jenna Rovira, Aitor Martin, Jennifer Hollis, Chris Clark, David M. Waite, Felicity Altunkaya, James https://orcid.org/0000-0002-8293-3466 Andleeb, Humma Bergin, Aislinn Bold, Emily Bond, Jessica Bransby-Adams, Kate Brown, Susan Chan, Cindy Chauhan, Nisha Craven, Michael Freeman, Jason Geddes, John Goodsell, Andrew Jenner, Lucy Kenny, Alex Leal, José Mitchell, Joanna Peel, Heather Pervez, Maryam Prouten, Eloise Roberts, Eva Robotham, Dan Walker, Harry West, Jonathan
Copyright, Publisher and Additional Information:	Funding Information: The trial was funded by the NHS NIHR Invention for Innovation (i4i) programme (project II-C7-0117-20001). It was also supported by the NIHR Oxford Health Biomedical Research Centre (BRC-1215-2000). DF is an NIHR Senior Investigator. DMC is an Emeritus NIHR Senior Investigator. CH is an NIHR Senior Investigator. AB, SB, MC, CH, and JMa are supported by the NIHR Nottingham Biomedical Research Centre and NIHR MindTech MedTech Co-operative. This paper presents independent research funded by the NIHR. The views expressed are those of the authors and do not necessarily represent those of the NHS, NIHR, or Department of Health and Social Care. FW is funded by a Wellcome Trust Clinical Doctoral Fellowship (102176/B/13/Z). We thank the trial participants; the gameChange LEAP team members (including Debbie Butler, Susie Booth, Len Demetriou, Zach Howarth, Mary Mancini, Cheryl Williams, and Christopher Wright [based in the UK]); the trial research assistants (Lydia Carr, Chiara Causier, Anna East, Miriam Kirkham, Sapphira McBride, Sophie Mulhall, Simone Saidel, Megan Smith, Ashley-Louise Teale, Eve Twivy [University of Oxford and Oxford Health NHS Foundation Trust, Oxford, UK]; Naomi Coulthard, Kelly Grieve, Negar Khozoee, Robert Nirsimloo [Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, UK]; Nikki Dehmahdi, Emma Izon [Greater Manchester Mental Health NHS Foundation Trust]; Mariella Henderson, Genevieve Quartey, Naomi Thrower, Kira Williams, Charlotte Way [Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK]); additional trial therapy deliverers (Poppy Brown [University of Oxford and Oxford Health NHS Foundation Trust], Rory Byrne [Greater Manchester Mental Health NHS Foundation Trust], Jason Horeesorun [Nottinghamshire Healthcare NHS Foundation Trust], Lyndsey Tunney [Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust]); research and development support teams (Andrea Cockram, Veronica French, Corinne Hendy [Nottinghamshire Healthcare NHS Foundation Trust]; Nick Raven, Bill Wells [Oxford Health NHS Foundation Trust]); the independent members of the Data Monitoring and Ethics Committee (David Kingdon, Issy Reading [University of Southampton, Southampton, UK]; Tom Craig [King's College London, London, UK]; Andrew Gumley [University of Glasgow, Glasgow, UK]); and the clinical teams in the participating NHS trusts. Funding Information: The trial was funded by the NHS NIHR Invention for Innovation (i4i) programme (project II-C7-0117-20001). It was also supported by the NIHR Oxford Health Biomedical Research Centre (BRC-1215-2000). DF is an NIHR Senior Investigator. DMC is an Emeritus NIHR Senior Investigator. CH is an NIHR Senior Investigator. AB, SB, MC, CH, and JMa are supported by the NIHR Nottingham Biomedical Research Centre and NIHR MindTech MedTech Co-operative. This paper presents independent research funded by the NIHR. The views expressed are those of the authors and do not necessarily represent those of the NHS, NIHR, or Department of Health and Social Care. FW is funded by a Wellcome Trust Clinical Doctoral Fellowship (102176/B/13/Z). We thank the trial participants; the gameChange LEAP team members (including Debbie Butler, Susie Booth, Len Demetriou, Zach Howarth, Mary Mancini, Cheryl Williams, and Christopher Wright [based in the UK]); the trial research assistants (Lydia Carr, Chiara Causier, Anna East, Miriam Kirkham, Sapphira McBride, Sophie Mulhall, Simone Saidel, Megan Smith, Ashley-Louise Teale, Eve Twivy [University of Oxford and Oxford Health NHS Foundation Trust, Oxford, UK]; Naomi Coulthard, Kelly Grieve, Negar Khozoee, Robert Nirsimloo [Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, UK]; Nikki Dehmahdi, Emma Izon [Greater Manchester Mental Health NHS Foundation Trust]; Mariella Henderson, Genevieve Quartey, Naomi Thrower, Kira Williams, Charlotte Way [Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK]); additional trial therapy deliverers (Poppy Brown [University of Oxford and Oxford Health NHS Foundation Trust], Rory Byrne [Greater Manchester Mental Health NHS Foundation Trust], Jason Horeesorun [Nottinghamshire Healthcare NHS Foundation Trust], Lyndsey Tunney [Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust]); research and development support teams (Andrea Cockram, Veronica French, Corinne Hendy [Nottinghamshire Healthcare NHS Foundation Trust]; Nick Raven, Bill Wells [Oxford Health NHS Foundation Trust]); the independent members of the Data Monitoring and Ethics Committee (David Kingdon, Issy Reading [University of Southampton, Southampton, UK]; Tom Craig [King's College London, London, UK]; Andrew Gumley [University of Glasgow, Glasgow, UK]); and the clinical teams in the participating NHS trusts. Funding Information: DF is a founder and a non-executive director of Oxford VR, which will commercialise the therapy; holds equity in and receives personal payments from Oxford VR; holds a contract for his university team to advise Oxford VR on treatment development; and reports grants from National Institute for Health Research (NIHR), Medical Research Council (MRC), and International Foundation. CH reports grants from NIHR and MRC; and was chair of the National Institute for Health and Care Excellence Guideline for psychosis and schizophrenia in children and young people (CG155). The University of Oxford, Oxford Health NHS Foundation Trust, McPin Foundation, NIHR MindTech MedTech Co-operative, and the Royal College of Art received a share of the licencing fee from Oxford VR for the gameChange software. DMC reports a Senior Investigator Award from the Wellcome Trust and is National Clinical and Informatic Advisor for the NHS Improving Access to Psychological Therapy (IAPT) programme. RD reports a grant from the NIHR, is a clinician working in the NHS delivering cognitive therapy, and receives payments for workshops of cognitive behavioural therapy and royalties from books on cognitive behavioural therapy. SL reports consultancy work and fees from Oxford VR. AP reports a grant from the NIHR. All other authors declare no competing interests. Publisher Copyright: © 2022 The Author(s).
Dates:	Published: 1 May 2022 Published (online): 5 April 2022
Institution:	The University of York
Academic Units:	The University of York > Faculty of Sciences (York) > Psychology (York) The University of York > Faculty of Social Sciences (York) > Centre for Health Economics (York)
Depositing User:	Pure (York)
Date Deposited:	07 Dec 2023 13:20
Last Modified:	21 Jan 2025 18:11
Published Version:	https://doi.org/10.1016/S2215-0366(22)00060-8
Status:	Published
Refereed:	Yes
Identification Number:	10.1016/S2215-0366(22)00060-8
Related URLs:	http://www.scopus.com/inward/record.url?...
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:206348

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Description: 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

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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

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