Automated virtual reality (VR) cognitive therapy for patients with psychosis: study protocol for a single-blind parallel group randomised controlled trial (gameChange)
Open accessAbstract
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 .
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
A large, ongoing randomized controlled trial of automated VR-CBT for anxious avoidance of social situations among patients with psychosis is underway.
“Recent advances in this field include a large, ongoing randomized controlled trial of automated VR-CBT for anxious avoidance of social situations among patients with psychosis (Freeman et al. 2019;Lambe et al. 2020).”
From Better, Virtually: the Past, Present, and Future of Virtual Reality Cognitive Behavior Therapy (2021) · cites this paper as Freeman et al. 2019
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
The PHQ-9: Validity of a brief depression severity measure
Kroenke, K., Spitzer, R. L., & Williams, J. B. W. (2001) · Journal of General Internal Medicine · doi:10.1046/j.1525-1497.2001.016009606.x · Cited by 44,910 · see citing works
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
the CONSORT Group, Schulz, K. F., Altman, D. G., & Moher, D. (2010) · BMC Medicine · doi:10.1186/1741-7015-8-18 · Cited by 13,371 · see citing works
Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)
Herdman, M., Gudex, C., Lloyd, A., Janssen, M., Kind, P., Parkin, D., Bonsel, G., & Badia, X. (2011) · Quality of Life Research · doi:10.1007/s11136-011-9903-x · Cited by 9,795 · cited 2× · see citing works
“The health economics will use an NHS and social care services perspective with resource utilisation valued using national cost data sets and EQ-5D-5L data converted into utilities using the UK tariffs.”
BackgroundPosner, K., Brown, G. K., Stanley, B., Brent, D. A., Yershova, K. V., Oquendo, M. A., Currier, G. W., Melvin, G. A., Greenhill, L., Shen, S., et al. (2011) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2011.10111704 · Cited by 5,157 · see citing works
International Statistical Classification of Diseases and Related Health Problems
Eisfeld, J. (2014) · TSQ Transgender Studies Quarterly · doi:10.1215/23289252-2399740 · Cited by 3,570 · see citing works
The client satisfaction questionnaire
Attkisson, C. C., & Zwick, R. (1982) · Evaluation and Program Planning · doi:10.1016/0149-7189(82)90074-x · Cited by 1,743 · see citing works
Virtual Reality in the Assessment, Understanding, and Treatment of Mental Health Disorders
Freeman, D., Reeve, S., Robinson, A., Ehlers, A., Clark, D., Spanlang, B., & Slater, M. (2017) · Psychological Medicine · doi:10.1017/s003329171700040x · Cited by 1,428 · see citing works
Self-citationHjorthøj, C., Stürup, A. E., McGrath, J. J., & Nordentoft, M. (2017) · The Lancet Psychiatry · doi:10.1016/s2215-0366(17)30078-0 · Cited by 1,304 · see citing works
Body-Esteem Scale for Adolescents and Adults
Mendelson, B. K., Mendelson, M. J., & White, D. R. (2001) · Journal of Personality Assessment · doi:10.1207/s15327752jpa7601_6 · Cited by 1,009 · see citing works
Carl, E., Stein, A. T., Levihn-Coon, A., Pogue, J. R., Rothbaum, B., Emmelkamp, P., Asmundson, G. J. G., Carlbring, P., & Powers, M. B. (2019) · Journal of Anxiety Disorders · doi:10.1016/j.janxdis.2018.08.003 · Cited by 889 · see citing works
The Mobility Inventory for Agoraphobia
Chambless, D. L., Caputo, G. C., Jasin, S. E., Gracely, E. J., & Williams, C. (1985) · Behaviour Research and Therapy · doi:10.1016/0005-7967(85)90140-8 · Cited by 775 · see citing works
Costing psychiatric interventions.
Beecham, J. K., & Knapp, M. R. J. (1992) · Kent Academic Repository (University of Kent) · Cited by 710 · see citing works
Effectiveness of computer-generated (virtual reality) graded exposure in the treatment of acrophobia
(1995) · American Journal of Psychiatry · doi:10.1176/ajp.152.4.626 · Cited by 694 · see citing works
Mayo-Wilson, E., Dias, S., Mavranezouli, I., Kew, K., Clark, D. M., Ades, A. E., & Pilling, S. (2014) · The Lancet Psychiatry · doi:10.1016/s2215-0366(14)70329-3 · Cited by 680 · see citing works
Self-citationSlade, M., & Thornicroft, G. (2025) · doi:10.1093/med/9780198898818.003.0007 · Cited by 679 · see citing works
Anxiety disorders: Why they persist and how to treat them
Clark, D. M. (1999) · Behaviour Research and Therapy · doi:10.1016/s0005-7967(99)00048-0 · Cited by 556 · cited 1× · see citing works
“The thoughts must then be tested in behavioural experiments in the troubling situations while the defence behaviours are dropped.(7) However, there is a dearth of therapists to carry out this skilled work for patients with schizophrenia.”
BackgroundSelf-citationMorina, N., Ijntema, H., Meyerbröker, K., & Emmelkamp, P. M. G. (2015) · Behaviour Research and Therapy · doi:10.1016/j.brat.2015.08.010 · Cited by 439 · see citing works
Green, C. E. L., Freeman, D., Kuipers, E., Bebbington, P., Fowler, D., Dunn, G., & Garety, P. A. (2008) · Psychological Medicine · doi:10.1017/s0033291707001638 · Cited by 401 · see citing works
Depression and Schizophrenia: Cause, Consequence or Trans-diagnostic Issue?
Upthegrove, R., Marwaha, S., & Birchwood, M. (2016) · Schizophrenia Bulletin · doi:10.1093/schbul/sbw097 · Cited by 400 · see citing works
Freeman, D., Haselton, P., Freeman, J., Spanlang, B., Kishore, S., Albery, E., Denne, M., Brown, P., Slater, M., & Nickless, A. (2018) · The Lancet Psychiatry · doi:10.1016/s2215-0366(18)30226-8 · Cited by 377 · see citing works
Self-citationNeil, S. T., Kilbride, M., Pitt, L., Nothard, S., Welford, M., Sellwood, W., & Morrison, A. P. (2009) · Psychosis · doi:10.1080/17522430902913450 · Cited by 362 · see citing works
Self-citationFreeman, D. H., Loe, B. S., Kingdon, D., Startup, H. M., Molodynski, A., Rosebrock, L. E., Brown, P., Sheaves, B., Waite, F., & Bird, J. C. (2019) · Psychological Medicine · doi:10.1017/s0033291719003155 · Cited by 308 · see citing works
Self-citationVirtual reality graded exposure in the treatment of acrophobia: A case report
ROTHBAUM, B. O., Hodges, L. F., Rob Kooper, A., Opdyke, D., Williford, J. S., & North, M. M. (1995) · Behavior Therapy · doi:10.1016/s0005-7894(05)80100-5 · Cited by 278 · see citing works
Keetharuth, A. D., Brazier, J. E., Connell, J., Bjørner, J. B., Carlton, J., Buck, E. T., Ricketts, T., McKendrick, K., Browne, J. P., Croudace, T. J., et al. (2018) · The British Journal of Psychiatry · doi:10.1192/bjp.2017.10 · Cited by 269 · see citing works
Freeman, D. H., Bradley, J., Antley, A., Bourke, E., DeWeever, N., Evans, N., Černis, E., Sheaves, B., Waite, F., Dunn, G., et al. (2016) · The British Journal of Psychiatry · doi:10.1192/bjp.bp.115.176438 · Cited by 243 · see citing works
Self-citationPot-Kolder, R. M. C. A., Geraets, C. N. W., Veling, W., van Beilen, M., Staring, A. B. P., Gijsman, H. J., Delespaul, P. A. E. G., & van der Gaag, M. (2018) · The Lancet Psychiatry · doi:10.1016/s2215-0366(18)30053-1 · Cited by 239 · see citing works
Testing the continuum of delusional beliefs: An experimental study using virtual reality.
Freeman, D. H., Pugh, K., Vorontsova, N., Antley, A., & Slater, M. (2010) · Journal of Abnormal Psychology · doi:10.1037/a0017514 · Cited by 198 · see citing works
Self-citationAssessment of physical activity in middle-aged and older adults with schizophrenia
Lindamer, L. A., McKibbin, C. L., Norman, G. J., Jordan, L. S., Harrison, K. A., Abeyesinhe, S., & Patrick, K. (2008) · Schizophrenia Research · doi:10.1016/j.schres.2008.04.040 · Cited by 145 · see citing works
Treatable clinical intervention targets for patients with schizophrenia
Freeman, D., Taylor, K. M., Molodynski, A., & Waite, F. (2019) · Schizophrenia Research · doi:10.1016/j.schres.2019.07.016 · Cited by 125 · see citing works
Self-citationA validation of a new measure of activity in psychosis
JOLLEY, S., GARETY, P., ELLETT, L., KUIPERS, E., FREEMAN, D., BEBBINGTON, P., FOWLER, D., & DUNN, G. (2006) · Schizophrenia Research · doi:10.1016/j.schres.2006.03.012 · Cited by 78 · see citing works
Self-citationFreeman, D. H., Lister, R., Waite, F., Yu, L., Slater, M., Dunn, G., & Clark, D. M. (2019) · Trials · doi:10.1186/s13063-019-3198-6 · Cited by 63 · see citing works
Self-citationA question of time: A study of time use in people with schizophrenia
Cella, M., Edwards, C., & Wykes, T. (2016) · Schizophrenia Research · doi:10.1016/j.schres.2016.06.033 · Cited by 52 · see citing works
The Dunn Worry Questionnaire and the Paranoia Worries Questionnaire: new assessments of worry
Freeman, D. H., Bird, J. C., Loe, B. S., Kingdon, D., Startup, H. M., Clark, D. M., Ehlers, A., Černis, E., Wingham, G., Evans, N., et al. (2019) · Psychological Medicine · doi:10.1017/s0033291719000588 · Cited by 48 · see citing works
Self-citationFreeman, D. H., Waite, F., Emsley, R., Kingdon, D., Davies, L. M., Fitzpatrick, R. M., & Dunn, G. (2016) · Trials · doi:10.1186/s13063-016-1245-0 · Cited by 29 · see citing works
Self-citation
Flagged first, then by citations
Research works printed but not linked: 3
- [19]Lambe S et al The self-report Oxford behavioural assessment task. University of Oxford, 2019.
- [30]Lambe S et al Cognitions and defences behaviour questionnaire. University of Oxford, 2019.
- [32]Rosebrock L et al Negative voices when outside questionnaire. University of Oxford, 2019.
Cited by
Sorted by citations
Virtual Reality for the Enhancement of Emotion Regulation
Colombo, D., Díaz‐García, A., Fernandez‐Álvarez, J., & Botella, C. (2021) · Clinical Psychology & Psychotherapy · doi:10.1002/cpp.2618 · Cited by 120 · see citing works
Better, Virtually: the Past, Present, and Future of Virtual Reality Cognitive Behavior Therapy
Lindner, P. (2021) · International Journal of Cognitive Therapy · doi:10.1007/s41811-020-00090-7 · Cited by 120 · see citing works
Developing an automated VR cognitive treatment for psychosis: gameChange VR therapy
Lambe, S., Knight, I., Kabir, T., West, J., Patel, R., Lister, R., Rosebrock, L., Rovira, A., Garnish, B., Freeman, J., et al. (2020) · Journal of Behavioral and Cognitive Therapy · doi:10.1016/j.jbct.2019.12.001 · Cited by 48 · see citing works
Self-citationTsamitros (2022) · doi:10.1007/s00115-022-01378-z · Cited by 16 · see citing works
Hoşgelen, E. I., Kartelli, F., Berger, M., Erinç, S., Yerlikaya, D., Özbek, Y., Yener, G., Akdede, B. B., & Alptekin, K. (2022) · Turkish Journal of Psychiatry · doi:10.5080/u27046 · Cited by 3 · see citing works
- Authors
- Freeman, D., Yu, L.-M., 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, T. L., Robotham, D., Andleeb, H., Geddes, J. R., Hollis, C., Clark, D. M., & Waite, F.
- Affiliations
- Oxford Health NHS Foundation Trust (GB)
- University of Oxford (GB)
- McPin Foundation (GB)
- University of Nottingham (GB)
- Greater Manchester Mental Health NHS Foundation Trust (GB)
- Avon and Wiltshire Mental Health Partnership NHS Trust (GB)
- Cumbria Northumberland Tyne and Wear NHS Foundation Trust (GB)
- Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK
- Corresponding author
- Freeman, Daniel
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2019-08
- Volume
- 9
- Issue
- 8
- Pages
- e031606
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC6720451
- OpenAlex
- W2970979717
- Cited by
- 52
- References
- 34
- Citations by year
- 2026: 2 · 2025: 5 · 2024: 4 · 2023: 5 · 2022: 14 · 2021: 12 · 2020: 9 · 2019: 1
- FWCI
- 8.51
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- BMJ Open (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Repository@Nottingham (University of Nottingham) (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Repository@Nottingham (University of Nottingham) (submittedVersion, cc-by)
- HighWire Press Open Archive (submittedVersion)
- Newcastle University ePrints (Newcastle Univesity) (cc-by)
- Funders
- National Institute for Health Research (II-C7-0117-20001)
- Topics
- Physical Sciences › Computer Science › Human-Computer Interaction › Virtual Reality Applications and Impacts
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- psychosis, virtual reality, cognitive behavioral therapy, social anxiety, avoidance behavior, virtual coach, social withdrawal, paranoia, hallucinations, usual care, quality of life, activity level
- MeSH terms
- England, Humans, Psychotic Disorders, Quality of Life, Therapy, Computer-Assisted, Time Factors, Multicenter Studies as Topic, Cognitive Behavioral Therapy, Randomized Controlled Trials as Topic, Single-Blind Method, Treatment Outcome, Virtual Reality Exposure Therapy
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
