Background

Automated delivery of psychological therapy using immersive technologies such as virtual reality (VR) might greatly increase the availability of effective help for patients. We aimed to evaluate the efficacy of an automated VR cognitive therapy (gameChange) to treat avoidance and distress in patients with psychosis, and to analyse how and in whom it might work.

Methods

We did a parallel-group, single-blind, randomised, controlled trial across nine National Health Service trusts in England. Eligible patients were aged 16 years or older, with a clinical diagnosis of a schizophrenia spectrum disorder or an affective diagnosis with psychotic symptoms, and had self-reported difficulties going outside due to anxiety. Patients were randomly assigned (1:1) to either gameChange VR therapy plus usual care or usual care alone, using a permuted blocks algorithm with randomly varying block size, stratified by study site and service type. gameChange VR therapy was provided in approximately six sessions over 6 weeks. Trial assessors were masked to group allocation. Outcomes were assessed at 0, 6 (primary endpoint), and 26 weeks after randomisation. The primary outcome was avoidance of, and distress in, everyday situations, assessed using the self-reported Oxford Agoraphobic Avoidance Scale (O-AS). Outcome analyses were done in the intention-to-treat population (ie, all participants who were assigned to a study group for whom data were available). We performed planned mediation and moderation analyses to test the effects of gameChange VR therapy when added to usual care. This trial is registered with the ISRCTN registry, 17308399.

Findings

Between July 25, 2019, and May 7, 2021 (with a pause in recruitment from March 16, 2020, to Sept 14, 2020, due to COVID-19 pandemic restrictions), 551 patients were assessed for eligibility and 346 were enrolled. 231 (67%) patients were men and 111 (32%) were women, 294 (85%) were White, and the mean age was 37·2 years (SD 12·5). 174 patients were randomly assigned to the gameChange VR therapy group and 172 to the usual care alone group. Compared with the usual care alone group, the gameChange VR therapy group had significant reductions in agoraphobic avoidance (O-AS adjusted mean difference –0·47, 95% CI –0·88 to –0·06; n=320; Cohen's d –0·18; p=0·026) and distress (–4·33, –7·78 to –0·87; n=322; –0·26; p=0·014) at 6 weeks. Reductions in threat cognitions and within-situation defence behaviours mediated treatment outcomes. The greater the severity of anxious fears and avoidance, the greater the treatment benefits. There was no significant difference in the occurrence of serious adverse events between the gameChange VR therapy group (12 events in nine patients) and the usual care alone group (eight events in seven patients; p=0·37).

Interpretation

Automated VR therapy led to significant reductions in anxious avoidance of, and distress in, everyday situations compared with usual care alone. The mediation analysis indicated that the VR therapy worked in accordance with the cognitive model by reducing anxious thoughts and associated protective behaviours. The moderation analysis indicated that the VR therapy particularly benefited patients with severe agoraphobic avoidance, such as not being able to leave the home unaccompanied. gameChange VR therapy has the potential to increase the provision of effective psychological therapy for psychosis, particularly for patients who find it difficult to leave their home, visit local amenities, or use public transport.

Funding

National Institute of Health Research Invention for Innovation programme, National Institute of Health Research Oxford Health Biomedical Research Centre.

中文翻译：

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自动虚拟现实疗法治疗精神病患者的广场恐惧症回避和痛苦（gameChange）：在英国进行的一项多中心、平行组、单盲、随机、对照试验，进行中介和调节分析

 背景

使用虚拟现实 (VR) 等沉浸式技术自动提供心理治疗可能会大大增加患者获得有效帮助的可能性。我们的目的是评估自动 VR 认知疗法 (gameChange) 在治疗精神病患者的回避和痛苦方面的功效，并分析它的作用方式和对象。

 方法

我们在英格兰的九个国家卫生服务信托机构中进行了一项平行组、单盲、随机、对照试验。符合条件的患者年龄在 16 岁或以上，临床诊断为精神分裂症谱系障碍或情感诊断为精神病症状，并且自我报告因焦虑而难以外出。患者被随机分配 (1:1) 接受 gameChange VR 治疗加常规护理或单独常规护理，使用随机变化块大小的置换块算法，按研究地点和服务类型分层。 gameChange VR 疗法在 6 周内分大约 6 次进行。试验评估人员对分组分配情况不知情。在随机分组后第 0、6（主要终点）和 26 周评估结果。主要结果是日常生活中的回避和痛苦，使用自我报告的牛津广场恐惧回避量表（O-AS）进行评估。结果分析是在意向治疗人群（即分配到有数据可用的研究组的所有参与者）中进行的。我们进行了有计划的中介和调节分析，以测试将 gameChange VR 疗法添加到常规护理中的效果。该试验已在 ISRCTN 注册处注册，编号为 17308399。

 发现

2019年7月25日至2021年5月7日期间（由于COVID-19大流行限制，招募从2020年3月16日至2020年9月14日暂停），对551名患者进行了资格评估，并入组了346名患者。 231 名患者 (67%) 为男性，111 名患者 (32%) 为女性，294 名患者 (85%) 为白人，平均年龄为 37·2 岁 (SD 12·5)。 174 名患者被随机分配到 gameChange VR 治疗组，172 名患者被分配到单独常规护理组。与单独常规护理组相比，gameChange VR 治疗组的广场恐惧症回避显着降低（O-AS 调整平均差 –0·47，95% CI –0·88 至 –0·06；n=320；Cohen d –0·18；p=0·026）和 6 周时的痛苦（–4·33、–7·78 至 –0·87；n=322；–0·26；p=0·014）。威胁认知和情境内防御行为的减少介导了治疗结果。焦虑恐惧和回避越严重，治疗效果就越大。 gameChange VR治疗组（9名患者中发生12起事件）和单独常规护理组（7名患者中发生8起事件；p=0·37）之间严重不良事件的发生率没有显着差异。

 解释

与单独的常规护理相比，自动化 VR 治疗可显着减少日常情况下的焦虑回避和痛苦。中介分析表明，VR 疗法通过减少焦虑想法和相关的保护行为，按照认知模型发挥作用。适度分析表明，VR 疗法特别有利于患有严重广场恐惧症的患者，例如无法在无人陪伴的情况下离开家的患者。 gameChange VR 疗法有可能增加对精神病的有效心理治疗，特别是对于那些难以离开家、访问当地设施或使用公共交通工具的患者。

 资金

国家卫生研究院发明创新计划、国家卫生研究院牛津健康生物医学研究中心。