Copenhagen Research Centre on Mental Health (CORE), University of Copenhagen, Copenhagen, Denmark.
Department of Psychology, University of Copenhagen, Copenhagen, Denmark.
Trials. 2022 Aug 15;23(1):658. doi: 10.1186/s13063-022-06614-0.
Schizophrenia spectrum disorders cause suffering for patients, relatives, and the surrounding society. Paranoid ideations, encompassing ideas of social reference and manifest persecutory delusions, are among the most frequent symptoms in this population and a cause of significant distress. Recent meta-analyses of cognitive behavioral therapy (CBT) for psychosis show small to moderate effect sizes in reducing paranoid ideations. Virtual reality-based CBT (VR-CBT) could improve therapy efficacy as exposure and behavioral experiments in VR can be optimized, individualized, and carried out in a safe environment. Few VR-CBT studies exist for paranoid ideations and there is a need for large-scale, methodologically rigorous trials.
This study is a randomized, assessor-blinded parallel-groups multi-center superiority clinical trial, fulfilling the CONSORT criteria for non-pharmacological treatment. A total of 256 patients diagnosed with schizophrenia spectrum disorder, including schizotypal disorder (ICD-10 F20-29), will be allocated to either 10 sessions of symptom-specific CBT-VR plus treatment as usual-versus 10 sessions of standard symptom-specific CBT for paranoid ideations (CBT) plus treatment as usual. All participants will be assessed at baseline, treatment end (3 months post baseline), and then 9 months post baseline. A stratified block-randomization with concealed randomization sequence will be conducted. Independent assessors blinded to the treatment will evaluate the outcome. Analysis of outcome will be carried out with the intention to treat principles. The primary outcome is ideas of social reference measured with Green Paranoid Thought Scale Part A (GPTS-A) at the cessation of treatment at 3 months post baseline. Secondary outcomes are ideas of persecution (GPTS-B), Social Interaction Anxiety Scale (SIAS), Personal and Social Performance scale (PSP), Safety Behavior Questionnaire (SBQ), and CANTAB Emotion Recognition Task.
The trial will elucidate whether VR-CBT can enhance therapy efficacy for paranoid ideations. Additionally, Trial findings will provide evidence on the effectiveness and cost-effectiveness of VR-CBT for paranoid ideations that can guide the possible dissemination and implementation into clinical practice.
ClinicalTrials.gov NCT04902066 . Initial release April 9th, 2021.
精神分裂症谱系障碍给患者、亲属和周围社会带来痛苦。偏执观念，包括社会参照观念和明显的被害妄想，是该人群中最常见的症状之一，也是造成严重困扰的原因。最近对认知行为疗法（CBT）治疗精神分裂症的荟萃分析显示，减少偏执观念的效果在小到中等之间。基于虚拟现实的 CBT（VR-CBT）可以提高治疗效果，因为在虚拟现实中进行暴露和行为实验可以得到优化、个性化，并在安全的环境中进行。针对偏执观念的 VR-CBT 研究较少，因此需要进行大规模、方法严谨的试验。
这是一项随机、评估者盲法、平行组、多中心优势临床试验，符合非药物治疗的 CONSORT 标准。共有 256 名被诊断为精神分裂症谱系障碍（包括精神分裂样障碍（ICD-10 F20-29））的患者将被分配到 10 节针对症状的 CBT-VR 加常规治疗，或 10 节针对偏执观念的标准针对症状的 CBT（CBT）加常规治疗。所有参与者将在基线、治疗结束（基线后 3 个月）和基线后 9 个月进行评估。将采用分层区组随机化和隐藏随机序列进行随机分组。独立的评估者对治疗情况进行盲法评估。将根据意向治疗原则进行结果分析。主要结局指标是在基线后 3 个月治疗结束时用 Green 偏执思维量表 A（GPTS-A）评估的社会参照观念。次要结局指标是迫害观念（GPTS-B）、社交互动焦虑量表（SIAS）、个人和社会表现量表（PSP）、安全行为问卷（SBQ）和 CANTAB 情绪识别任务。
该试验将阐明 VR-CBT 是否可以增强偏执观念的治疗效果。此外，试验结果将提供针对偏执观念的 VR-CBT 的有效性和成本效益的证据，这可以为可能的传播和实施到临床实践提供指导。
ClinicalTrials.gov NCT04902066。初始发布日期为 2021 年 4 月 9 日。
