Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial

Abstract Background Seventy per cent of patients with psychotic disorders has paranoid delusions. Paranoid delusions are associated with significant distress, hospital admission and social isolation. Cognitive-behavioural therapy for psychosis (CBTp) is the primary psychological treatment, but the m...

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Main Authors: M. Berkhof, E. C. D. van der Stouwe, B. Lestestuiver, E. van’t Hag, R. van Grunsven, J. de Jager, E. Kooijmans, C. E. R. Zandee, A. B. P. Staring, R. M. C. A. Pot-Kolder, M. Vos, W. Veling
Format: Article
Language:English
Published: BMC 2021-10-01
Series:BMC Psychiatry
Subjects:
Online Access:https://doi.org/10.1186/s12888-021-03473-y
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author M. Berkhof
E. C. D. van der Stouwe
B. Lestestuiver
E. van’t Hag
R. van Grunsven
J. de Jager
E. Kooijmans
C. E. R. Zandee
A. B. P. Staring
R. M. C. A. Pot-Kolder
M. Vos
W. Veling
author_facet M. Berkhof
E. C. D. van der Stouwe
B. Lestestuiver
E. van’t Hag
R. van Grunsven
J. de Jager
E. Kooijmans
C. E. R. Zandee
A. B. P. Staring
R. M. C. A. Pot-Kolder
M. Vos
W. Veling
author_sort M. Berkhof
collection DOAJ
description Abstract Background Seventy per cent of patients with psychotic disorders has paranoid delusions. Paranoid delusions are associated with significant distress, hospital admission and social isolation. Cognitive-behavioural therapy for psychosis (CBTp) is the primary psychological treatment, but the median effect size is only small to medium. Virtual reality (VR) has a great potential to improve the effectiveness of CBTp. In a previous study, we found that VR based CBT (VRcbt) for paranoid delusions is superior to waiting list. As a next step, a direct comparison with CBTp is needed. The present study aims to investigate whether VRcbt is more effective and cost-effective than regular CBTp in treating paranoid delusions and improving daily life social functioning of patients with psychotic disorders. Methods A total of 106 patients with DSM-5 diagnosis of psychotic disorder and at least moderate level of paranoid ideations will be recruited for this multicentre randomized controlled trial (RCT). Patients will be randomized to either VRcbt or standard CBTp for paranoid delusions. VRcbt consists of maximum 16 sessions in virtual social situations that trigger paranoid ideations and distress, delivered in an 8–12 week time frame. Standard CBTp also consists of maximum 16 sessions including exposure and behavioural experiments, delivered in an 8–12 week time frame. The two groups will be compared at baseline, post-treatment and six months follow-up. Primary outcome is the level of paranoid ideations in daily life social situations, measured with ecological momentary assessments (EMA) at semi-random moments ten times a day during seven days, before and after treatment. Every session, participants and therapists will rate the level of paranoid ideation and global clinical impression. Discussion Comparison of VRcbt and CBTp will provide information about the relative (cost-) effectiveness of VRcbt for this population. VRcbt may become a preferred psychological treatment for paranoid delusions and social anxiety in patients with psychotic disorder. Trial registration Netherlands Trial Register, NL7758. Registered on 23 May 2019.
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spelling doaj.art-d5877ef814f846c5a2bd2cb85683b61e2022-12-21T20:12:29ZengBMCBMC Psychiatry1471-244X2021-10-0121111010.1186/s12888-021-03473-yVirtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trialM. Berkhof0E. C. D. van der Stouwe1B. Lestestuiver2E. van’t Hag3R. van Grunsven4J. de Jager5E. Kooijmans6C. E. R. Zandee7A. B. P. Staring8R. M. C. A. Pot-Kolder9M. Vos10W. Veling11University Medical Centre Groningen, University of GroningenUniversity Medical Centre Groningen, University of GroningenUniversity Medical Centre Groningen, University of GroningenUniversity Medical Centre Groningen, University of GroningenParnassia Psychiatry InstituteMental Health Service Organization GGZ Noord-Holland-NoordPro Persona, ArnhemFlexible Assertive Community Treatment Team, Outpatient Treatment CenterFirst Episode and Early Detection and Intervention Service, Altrecht Psychiatric InstituteDepartment of Clinical Psychology, VU UniversityUniversity Medical Centre Groningen, University of GroningenUniversity Medical Centre Groningen, University of GroningenAbstract Background Seventy per cent of patients with psychotic disorders has paranoid delusions. Paranoid delusions are associated with significant distress, hospital admission and social isolation. Cognitive-behavioural therapy for psychosis (CBTp) is the primary psychological treatment, but the median effect size is only small to medium. Virtual reality (VR) has a great potential to improve the effectiveness of CBTp. In a previous study, we found that VR based CBT (VRcbt) for paranoid delusions is superior to waiting list. As a next step, a direct comparison with CBTp is needed. The present study aims to investigate whether VRcbt is more effective and cost-effective than regular CBTp in treating paranoid delusions and improving daily life social functioning of patients with psychotic disorders. Methods A total of 106 patients with DSM-5 diagnosis of psychotic disorder and at least moderate level of paranoid ideations will be recruited for this multicentre randomized controlled trial (RCT). Patients will be randomized to either VRcbt or standard CBTp for paranoid delusions. VRcbt consists of maximum 16 sessions in virtual social situations that trigger paranoid ideations and distress, delivered in an 8–12 week time frame. Standard CBTp also consists of maximum 16 sessions including exposure and behavioural experiments, delivered in an 8–12 week time frame. The two groups will be compared at baseline, post-treatment and six months follow-up. Primary outcome is the level of paranoid ideations in daily life social situations, measured with ecological momentary assessments (EMA) at semi-random moments ten times a day during seven days, before and after treatment. Every session, participants and therapists will rate the level of paranoid ideation and global clinical impression. Discussion Comparison of VRcbt and CBTp will provide information about the relative (cost-) effectiveness of VRcbt for this population. VRcbt may become a preferred psychological treatment for paranoid delusions and social anxiety in patients with psychotic disorder. Trial registration Netherlands Trial Register, NL7758. Registered on 23 May 2019.https://doi.org/10.1186/s12888-021-03473-yPsychotic disorderParanoiaDelusionsSocial anxietyVirtual realityCognitive Behavioural therapy
spellingShingle M. Berkhof
E. C. D. van der Stouwe
B. Lestestuiver
E. van’t Hag
R. van Grunsven
J. de Jager
E. Kooijmans
C. E. R. Zandee
A. B. P. Staring
R. M. C. A. Pot-Kolder
M. Vos
W. Veling
Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial
BMC Psychiatry
Psychotic disorder
Paranoia
Delusions
Social anxiety
Virtual reality
Cognitive Behavioural therapy
title Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial
title_full Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial
title_fullStr Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial
title_full_unstemmed Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial
title_short Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial
title_sort virtual reality cognitive behavioural therapy versus cognitive behavioural therapy for paranoid delusions a study protocol for a single blind multi centre randomised controlled superiority trial
topic Psychotic disorder
Paranoia
Delusions
Social anxiety
Virtual reality
Cognitive Behavioural therapy
url https://doi.org/10.1186/s12888-021-03473-y
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