Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
South London & Maudsley NHS Foundation Trust, London, UK.
Trials. 2021 May 25;22(1):366. doi: 10.1186/s13063-021-05301-w.
AVATAR therapy is a novel intervention targeting distressing auditory verbal hallucinations (henceforth 'voices'). A digital simulation (avatar) of the voice is created and used in a three-way dialogue between participant, avatar and therapist. To date, therapy has been delivered over 6 sessions, comprising an initial phase, focusing on standing up to a hostile avatar, and a second phase in which the avatar concedes and focus shifts to individualised treatment targets, including beliefs about voices. The first fully powered randomised trial found AVATAR therapy resulted in a rapid and substantial fall in voice frequency and associated distress that was superior to supportive counselling at 12 weeks. The main objective of this AVATAR2 trial is to test the efficacy of two forms of AVATAR therapy in reducing voice-related distress: AVATAR-brief (standardised focus on exposure, assertiveness and self-esteem) and AVATAR-extended (phase 1 mirroring AVATAR-brief augmented by a formulation-driven phase 2). Secondary objectives include the examination of additional voice, wellbeing and mood outcomes, the exploration of mediators and moderators of therapy response, and examining cost-effectiveness of both forms of therapy compared with usual treatment (TAU).
This multi-site parallel group randomised controlled trial will independently randomise 345 individuals to receive AVATAR-brief (6 sessions) plus TAU or AVATAR-extended (12 sessions) plus TAU or TAU alone (1:1:1 allocation). Participants will be people with a diagnosis of schizophrenia spectrum and other psychotic disorders who have heard distressing voices for more than 6 months. The primary outcome is the PSYRATS Auditory Hallucinations Distress dimension score at 16 and 28 weeks, conducted by blinded assessors. Statistical analysis will follow the intention-to-treat principle and data will be analysed using linear mixed models. Mediation and moderation analyses using contemporary causal inference methods will be conducted as secondary analyses. Service costs will be calculated, and cost-effectiveness assessed in terms of quality-adjusted life years accrued.
This study will clarify optimal therapy delivery, test efficacy in a multi-site study and enable the testing of the AVATAR software platform, therapy training and provision in NHS settings.
ISRCTN registry ISRCTN55682735 . Registered on 22 January 2020. The trial is funded by the Wellcome Trust (WT).
AVATAR 疗法是一种针对令人痛苦的听觉言语幻觉（简称“幻听”）的新型干预措施。创建一个声音的数字模拟（化身），并在参与者、化身和治疗师之间进行三方对话。迄今为止，该疗法已进行了 6 个疗程，包括一个初始阶段，重点是对抗一个充满敌意的化身，以及第二个阶段，重点是针对个人治疗目标，包括对声音的信念。首次完全有力的随机试验发现，AVATAR 疗法可迅速显著降低幻听频率及其相关痛苦，在 12 周时优于支持性咨询。AVATAR2 试验的主要目的是测试两种 AVATAR 疗法在减轻与声音相关的痛苦方面的疗效：AVATAR-简短（标准化重点是暴露、自信和自尊）和 AVATAR-扩展（第 1 阶段模仿 AVATAR-简短，第 2 阶段增加基于配方的阶段）。次要目标包括检查额外的声音、健康和情绪结果，探索治疗反应的中介和调节因素，并检查两种疗法与常规治疗（TAU）相比的成本效益。
这项多地点平行组随机对照试验将独立随机分配 345 名参与者接受 AVATAR-简短（6 个疗程）加 TAU 或 AVATAR-扩展（12 个疗程）加 TAU 或 TAU 单独治疗（1:1:1 分配）。参与者将是被诊断为精神分裂症谱系和其他精神病性障碍的人，他们已经听到令人痛苦的声音超过 6 个月。主要结局是 16 周和 28 周时 PSYRATS 听觉幻觉痛苦维度评分，由盲法评估者进行。统计分析将遵循意向治疗原则，使用线性混合模型进行数据分析。使用现代因果推理方法进行中介和调节分析将作为次要分析进行。将计算服务成本，并根据获得的质量调整生命年来评估成本效益。
这项研究将阐明最佳治疗方法，在多地点研究中检验疗效，并能够测试 AVATAR 软件平台、治疗培训和在 NHS 环境中的提供。
ISRCTN 注册处 ISRCTN55682735 。于 2020 年 1 月 22 日注册。该试验由惠康信托基金（WT）资助。
