RELATE - A randomized controlled trial of a cognitive behavioural module for distressing auditory verbal hallucinations

幻听（AH）与痛苦和功能下降有关。心理干预显示出对精神病理学的有希望的效果，但在减少AH相关的痛苦方面不太成功，患者报告这是一个优先事项。研究表明，痛苦与听话人以被动和从属的方式与AH相关。因此，一种新颖的方法是使用经验角色扮演来教授对AH的自信反应。英国的一项小型试点研究证明了这种方法对AH困扰的巨大影响，但需要进行一项独立的多中心研究来确定不同环境下的有效性。计划的可行性试验旨在估计后续完全把握度前瞻性、随机化、对照、平行组、双臂、多中心、开放性试验的预期效果，以证明在按需治疗（TAU）中添加相关模块（RM）在减少AH痛苦方面上级单独TAU。可行性问题涉及不同类型的心理和精神病门诊设施的患者招募，治疗师培训和治疗监测。将在3个研究中心招募总计75例诊断为精神分裂症谱系障碍（ICD-10，F2）和持续性痛苦AH的患者，并在4个月内接受16次50分钟的RM + TAU或单独TAU治疗。将在基线、4个月（干预后）和9个月（主要终点）时进行评估。

Auditory hallucinations (AH) are associated with distress and reduced functioning. Psychological interventions show promising effects on psychopathology but have been less successful in reducing AH related distress, which patients report to be a priority. Research suggests that distress is associated with the hearer relating to AH in a passive and subordinate manner. A novel approach thus teaches assertive responses to AH using experiential role-plays. A small pilot study in the United Kingdom evidenced a large effect of this approach on AH distress but an independent multicentre study is required to ascertain effectiveness across different settings. The planned feasibility trial aims to estimate the expected effect for a subsequent fully powered prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial to demonstrate that adding a Relating Module (RM) to Treatment as Usual (TAU) is superior to TAU alone in reducing AH distress. Feasibility questions relate to patient recruitment, therapist training and therapy monitoring in different types of psychological and psychiatric outpatient facilities. A total of 75 patients diagnosed with a schizophrenia spectrum disorder (ICD-10, F2) and persistent distressing AH will be recruited across 3 sites and receive either 16 50-minute sessions of RM plus TAU or TAU alone within a 4-months period. Assessments will take place at baseline, at 4 months (post-intervention) and at 9 months (primary endpoint).