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Treatment effect modifiers of virtual reality-based versus standard cognitive behavioral therapy for paranoia in schizophrenia spectrum disorders: an exploratory moderator analysis of clinical and demographic characteristics in the FaceYourFears trial.

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Τίτλος: Treatment effect modifiers of virtual reality-based versus standard cognitive behavioral therapy for paranoia in schizophrenia spectrum disorders: an exploratory moderator analysis of clinical and demographic characteristics in the FaceYourFears trial.
Συγγραφείς: Christensen MJ; Department of Psychiatry, https://ror.org/02jk5qe80Aalborg University Hospital, Aalborg, North Denmark Region, Denmark.; Department of Clinical Medicine, Aalborg University, Denmark., Vernal DL; Department of Psychiatry, https://ror.org/02jk5qe80Aalborg University Hospital, Aalborg, North Denmark Region, Denmark.; Department of Clinical Medicine, Aalborg University, Denmark., Jeppesen UN; Department of Psychology, https://ror.org/035b05819University of Copenhagen, Denmark.; VIRTU Research Group, Mental Health Center Copenhagen, https://ror.org/035b05819Copenhagen University Hospital - Mental Health Services CPH, Denmark., Hjorthøj C; Department of Public Health, https://ror.org/035b05819University of Copenhagen, Denmark.; https://ror.org/035b05819Copenhagen Research Centre for Mental Health (CORE), Capital Region, Denmark., Mainz J; Department of Psychiatry, https://ror.org/02jk5qe80Aalborg University Hospital, Aalborg, North Denmark Region, Denmark.; Department of Clinical Medicine, Aalborg University, Denmark.; Department of Health Economics, https://ror.org/03yrrjy16University of Southern Denmark, Odense, Denmark., Pinkham A; School of Behavioral and Brain Sciences, https://ror.org/049emcs32University of Texas at Dallas, USA., Austin S; Department of Psychology, https://ror.org/035b05819University of Copenhagen, Denmark.; Mental Health Services East, https://ror.org/035b05819Copenhagen University Hospital - Psychiatry Region Zealand, Roskilde, Denmark., Veling W; Centre of Psychiatry, University Medical Center Groningen, Faculty of Medical Sciences, https://ror.org/03cv38k47University of Groningen, Netherlands., Ward T; South London & Maudsley NHS Foundation Trust, London, UK.; Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, https://ror.org/0220mzb33King's College London, London, UK., Nordentoft M; https://ror.org/035b05819Copenhagen Research Centre for Mental Health (CORE), Capital Region, Denmark.; Department of Clinical Medicine, Faculty of Health and Medical Sciences, https://ror.org/035b05819University of Copenhagen, Denmark., Glenthøj LB; Department of Psychology, https://ror.org/035b05819University of Copenhagen, Denmark.; VIRTU Research Group, Mental Health Center Copenhagen, https://ror.org/035b05819Copenhagen University Hospital - Mental Health Services CPH, Denmark.
Πηγή: Psychological medicine [Psychol Med] 2026 Apr 27; Vol. 56, pp. e117. Date of Electronic Publication: 2026 Apr 27.
Τύπος έκδοσης: Equivalence Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Cambridge University Press Country of Publication: England NLM ID: 1254142 Publication Model: Electronic Cited Medium: Internet ISSN: 1469-8978 (Electronic) Linking ISSN: 00332917 NLM ISO Abbreviation: Psychol Med Subsets: MEDLINE
Imprint Name(s): Publication: London : Cambridge University Press
Original Publication: London, British Medical Assn.
Ιατρικοί όροι (MeSH): Cognitive Behavioral Therapy*/methods , Paranoid Disorders*/therapy , Paranoid Disorders*/etiology , Psychotic Disorders*/therapy , Psychotic Disorders*/complications , Schizophrenia*/complications , Schizophrenia*/therapy , Virtual Reality Exposure Therapy*/methods, Adult ; Female ; Humans ; Male ; Middle Aged ; Delusions ; Treatment Effect Heterogeneity ; Treatment Outcome ; Virtual Reality
Περίληψη: Background: This exploratory study examined baseline characteristics modifying treatment effects on paranoia in individuals diagnosed with schizophrenia spectrum disorders following a 10-session virtual reality-based cognitive behavioral therapy for psychosis (VR-CBTp) or standard CBTp.
Methods: All participants in the FaceYourFears trial were included (n=254; CBTp n=128; VR-CBTp n=126). General linear and logistic regression models examined baseline variables associated with end-of-treatment paranoia. In covariate analyses, regression coefficients quantified associations across treatments. In moderation analyses, interaction terms (randomization x moderator) were tested, with corresponding regression coefficients estimated and assessed at the 25th (low), 50th (medium), and 75th (high) percentiles of continuous variables.
Results: Across treatments, higher baseline avolition, safety behavior, delusion severity, and cognitive biases were associated with end-of-treatment paranoia. Moderation analyses revealed interactions for avolition, delusion severity, and negative other-beliefs. Although avolition and delusion severity were associated with poorer outcomes overall, individuals with high avolition and those with moderate-to-high delusion severity improved more in VR-CBTp than CBTp, whereas participants with lower delusion severity showed better outcomes in CBTp. No demographic (age, gender, education, and occupation) or other clinical characteristics (diagnosis, paranoia, social anxiety, depression, anhedonia, total negative symptoms, functioning, core beliefs, or interpersonal trauma) were significantly associated with outcome.
Conclusions: This exploratory study generates hypotheses for future research, including VR-CBTp's potential to engage individuals with high avolition. Given the modest effects and largely nonsignificant findings, both CBTp and VR-CBTp appear suitable for a wide range of individuals with paranoia, highlighting the importance of considering patient preferences.
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Grant Information: 148727 TrygFonden; 0134-00066B Danmarks Frie Forskningsfond; L-2021-00244 Fonden til Lægevidenskabens Fremme
Contributed Indexing: Keywords: cognitive behavioral therapy; delusions; effect modifier; immersive virtual reality; paranoia; psychosis; schizophrenia spectrum disorders
Molecular Sequence: ClinicalTrials.gov NCT04902066
Entry Date(s): Date Created: 20260427 Date Completed: 20260715 Latest Revision: 20260902
Update Code: 20260903
PubMed Central ID: PMC13125928
DOI: 10.1017/S0033291726103870
PMID: 42037481
Βάση Δεδομένων: MEDLINE
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  Data: Treatment effect modifiers of virtual reality-based versus standard cognitive behavioral therapy for paranoia in schizophrenia spectrum disorders: an exploratory moderator analysis of clinical and demographic characteristics in the FaceYourFears trial.
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  Data: <searchLink fieldCode="AU" term="%22Christensen+MJ%22">Christensen MJ</searchLink>; Department of Psychiatry, https://ror.org/02jk5qe80Aalborg University Hospital, Aalborg, North Denmark Region, Denmark.; Department of Clinical Medicine, Aalborg University, Denmark.<br /><searchLink fieldCode="AU" term="%22Vernal+DL%22">Vernal DL</searchLink>; Department of Psychiatry, https://ror.org/02jk5qe80Aalborg University Hospital, Aalborg, North Denmark Region, Denmark.; Department of Clinical Medicine, Aalborg University, Denmark.<br /><searchLink fieldCode="AU" term="%22Jeppesen+UN%22">Jeppesen UN</searchLink>; Department of Psychology, https://ror.org/035b05819University of Copenhagen, Denmark.; VIRTU Research Group, Mental Health Center Copenhagen, https://ror.org/035b05819Copenhagen University Hospital - Mental Health Services CPH, Denmark.<br /><searchLink fieldCode="AU" term="%22Hjorthøj+C%22">Hjorthøj C</searchLink>; Department of Public Health, https://ror.org/035b05819University of Copenhagen, Denmark.; https://ror.org/035b05819Copenhagen Research Centre for Mental Health (CORE), Capital Region, Denmark.<br /><searchLink fieldCode="AU" term="%22Mainz+J%22">Mainz J</searchLink>; Department of Psychiatry, https://ror.org/02jk5qe80Aalborg University Hospital, Aalborg, North Denmark Region, Denmark.; Department of Clinical Medicine, Aalborg University, Denmark.; Department of Health Economics, https://ror.org/03yrrjy16University of Southern Denmark, Odense, Denmark.<br /><searchLink fieldCode="AU" term="%22Pinkham+A%22">Pinkham A</searchLink>; School of Behavioral and Brain Sciences, https://ror.org/049emcs32University of Texas at Dallas, USA.<br /><searchLink fieldCode="AU" term="%22Austin+S%22">Austin S</searchLink>; Department of Psychology, https://ror.org/035b05819University of Copenhagen, Denmark.; Mental Health Services East, https://ror.org/035b05819Copenhagen University Hospital - Psychiatry Region Zealand, Roskilde, Denmark.<br /><searchLink fieldCode="AU" term="%22Veling+W%22">Veling W</searchLink>; Centre of Psychiatry, University Medical Center Groningen, Faculty of Medical Sciences, https://ror.org/03cv38k47University of Groningen, Netherlands.<br /><searchLink fieldCode="AU" term="%22Ward+T%22">Ward T</searchLink>; South London & Maudsley NHS Foundation Trust, London, UK.; Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, https://ror.org/0220mzb33King's College London, London, UK.<br /><searchLink fieldCode="AU" term="%22Nordentoft+M%22">Nordentoft M</searchLink>; https://ror.org/035b05819Copenhagen Research Centre for Mental Health (CORE), Capital Region, Denmark.; Department of Clinical Medicine, Faculty of Health and Medical Sciences, https://ror.org/035b05819University of Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Glenthøj+LB%22">Glenthøj LB</searchLink>; Department of Psychology, https://ror.org/035b05819University of Copenhagen, Denmark.; VIRTU Research Group, Mental Health Center Copenhagen, https://ror.org/035b05819Copenhagen University Hospital - Mental Health Services CPH, Denmark.
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  Data: <searchLink fieldCode="JN" term="%221254142%22">Psychological medicine</searchLink> [Psychol Med] 2026 Apr 27; Vol. 56, pp. e117. <i>Date of Electronic Publication: </i>2026 Apr 27.
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  Data: Equivalence Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Background: This exploratory study examined baseline characteristics modifying treatment effects on paranoia in individuals diagnosed with schizophrenia spectrum disorders following a 10-session virtual reality-based cognitive behavioral therapy for psychosis (VR-CBTp) or standard CBTp.<br />Methods: All participants in the FaceYourFears trial were included (n=254; CBTp n=128; VR-CBTp n=126). General linear and logistic regression models examined baseline variables associated with end-of-treatment paranoia. In covariate analyses, regression coefficients quantified associations across treatments. In moderation analyses, interaction terms (randomization x moderator) were tested, with corresponding regression coefficients estimated and assessed at the 25th (low), 50th (medium), and 75th (high) percentiles of continuous variables.<br />Results: Across treatments, higher baseline avolition, safety behavior, delusion severity, and cognitive biases were associated with end-of-treatment paranoia. Moderation analyses revealed interactions for avolition, delusion severity, and negative other-beliefs. Although avolition and delusion severity were associated with poorer outcomes overall, individuals with high avolition and those with moderate-to-high delusion severity improved more in VR-CBTp than CBTp, whereas participants with lower delusion severity showed better outcomes in CBTp. No demographic (age, gender, education, and occupation) or other clinical characteristics (diagnosis, paranoia, social anxiety, depression, anhedonia, total negative symptoms, functioning, core beliefs, or interpersonal trauma) were significantly associated with outcome.<br />Conclusions: This exploratory study generates hypotheses for future research, including VR-CBTp's potential to engage individuals with high avolition. Given the modest effects and largely nonsignificant findings, both CBTp and VR-CBTp appear suitable for a wide range of individuals with paranoia, highlighting the importance of considering patient preferences.
– Name: Ref
  Label: References
  Group: RefInfo
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  Data: 148727 TrygFonden; 0134-00066B Danmarks Frie Forskningsfond; L-2021-00244 Fonden til Lægevidenskabens Fremme
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  Data: <i>Keywords: </i>cognitive behavioral therapy; delusions; effect modifier; immersive virtual reality; paranoia; psychosis; schizophrenia spectrum disorders
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