The effects of an Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR therapy): study protocol for a randomised controlled trial
The effects of an Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR therapy): study protocol for a randomised controlled trial
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DOI：
10.1186/s13063-015-0888-6
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发表时间：
2015-08-13
期刊：
影响因子：
2.5
通讯作者：
Garety, Philippa
中科院分区：
文献类型：
--
作者：
Craig, Tom K. J.;Rus-Calafell, Mar;Garety, Philippa
背景：采用明确的人际方法的心理干预是治疗痛苦声音的最新发展。化身疗法就是这样一种方法，它在声音听到者和他们的迫害声音（化身）的计算机化表示之间建立直接对话，通过这种对话，人们可以得到支持，以获得更大的权力和控制感。该试验的主要目的是测试该疗法降低幻听（AVH）频率和严重程度的临床疗效。该研究的次要目标是探索作用的解释机制和潜在的调节因素，对参与者的体验进行定性评估并进行经济评估。方法/设计：AVATAR 随机临床试验将独立随机分配 142 名参与者，接受 7 次 AVATAR 治疗或支持性咨询 (SC)。研究人群将是患有精神分裂症谱系和其他精神障碍的个体，他们报告称在超过 12 个月内听到持续令人痛苦的声音，这些声音对抗精神病药物没有反应或仅部分反应。主要假设是，与 SC 相比，AVATAR 疗法将降低 AVH 的频率和严重程度，并且还将减少所报道的这些声音的无所不能和恶意。评估将在第 0 周（基线）、12 周（干预后）和 24 周（随访）时进行，并将由盲法评估员进行。这两种干预措施都将在社区心理健康中心提供。将监测两组的治疗能力和依从性。统计分析将遵循意向治疗原则，并在每个治疗后时间点使用混合（随机）效应模型分别分析数据。作为二次分析，将使用当代因果推理方法进行正式的中介和调节分析。该试验由 Welcome Trust (WT) 资助。讨论：AVATAR 疗法在一项试点研究中显示出有希望的效果，但该方法的疗效需要在更大规模的随机临床试验中进行检验，然后才能在心理健康服务中广泛传播和实施。
Background: Psychological interventions which adopt an explicitly interpersonal approach are a recent development in the treatment of distressing voices. AVATAR therapy is one such approach which creates a direct dialogue between a voice-hearer and a computerised representation of their persecutory voice (the avatar) through which the person may be supported to gain a sense of greater power and control. The main objective of the trial is to test the clinical efficacy of this therapy to reduce the frequency and severity of auditory verbal hallucinations (AVH). Secondary objectives of the study are to explore explanatory mechanisms of action and potential moderators, to carry out a qualitative evaluation of participants' experience and to conduct an economic evaluation.Methods/Design: The AVATAR randomised clinical trial will independently randomise 142 participants to receive either 7 sessions of AVATAR therapy or supportive counselling (SC). The study population will be individuals with schizophrenia spectrum and other psychotic disorders who report hearing persistent distressing voices, for more than 12 months, which are unresponsive or only partially responsive to antipsychotic medication. The main hypotheses are that, compared to SC, AVATAR therapy will reduce the frequency and severity of AVH and will also reduce the reported omnipotence and malevolence of these voices. Assessments will occur at 0 weeks (baseline), 12 weeks (post-intervention) and 24 weeks (follow-up), and will be carried out by blinded assessors. Both interventions will be delivered in a community-based mental health centre. Therapy competence and adherence will be monitored in both groups. Statistical analysis will follow the intention-to-treat principle and data will be analysed using a mixed (random) effects model at each post treatment time point separately. A formal mediation and moderator analysis using contemporary causal inference methods will be conducted as a secondary analysis. The trial is funded by the Welcome Trust (WT).Discussion: AVATAR therapy showed promising effects in a pilot study, but the efficacy of the approach needs to be examined in a larger randomised clinical trial before wider dissemination and implementation in mental health services.