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.
Background Seventy percent of patients with schizophrenia and other psychotic disorders has paranoid delusions. Paranoid delusions are associated with great distress, hospital admission and social isolation. Cognitive behavioral therapy (CBT) is the main psychological treatment, but the median effect size is only small to medium. Virtual reality (VR) has a great potential to improve psychological treatment of paranoid delusions. In a previous study, we found that VR based CBT (VRcbt) for paranoid delusions is effective compared to waiting list. As a next step, a direct comparison with standard CBT is needed. The aim of this project is to investigate if VRcbt is more (cost-)effective than standard CBT for treatment of paranoid delusions and improving daily life social functioning of patients with schizophrenia and related psychotic disorders. Three research questions will be addressed: 1. Does VRcbt lead to better clinical and social outcomes? 2. Are fewer treatment sessions needed to achieve meaningful clinical change? 3. Is VRcbt more cost-effective at 6 months follow-up? Methods A total of 106 patients with DSM-5 diagnosis of psychotic disorder and at least moderate level of paranoid ideations will be randomized to either VRcbt or standard CBT treatment 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 CBT also consists of maximum 16 sessions, aiming at reappraisal of the meaning of paranoid beliefs to reduce distress and improve coping in daily life, including the use of exposure and behavioral experiments. Participants will be interviewed and tested at baseline, post-treatment and at six months follow-up. Primary outcome is 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 level of paranoid ideation and global clinical impression. Results Seven mental health services throughout the Netherlands participate in this RCT. Up until now, fourteen psychologists have been trained in VRcbt and the first patients have been included in the trial. Discussion Comparison of VRcbt and cbt will provide information about the relative (cost-)effectiveness of VRcbt for this population. VRcbt may become the preferred psychological treatment for paranoid delusions and social anxiety in patients with psychotic disorder.
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