INTRODUCTION There is a significant demand for interventions that reduce distress related to auditory verbal hallucinations (AVHs). AVH distress is associated with the way voice hearers relate with AVHs. We aimed to establish the feasibility of a randomized controlled trial to demonstrate that adding "Relating Therapy" (RT) to treatment as usual (TAU) is superior to TAU in reducing AVH distress. METHODS We conducted a multicenter, parallel, single-blind, randomized controlled feasibility trial in five mental health centers in Germany. Participants were ≥19 years of age, had persistent and distressing AVHs, and had a diagnosis of a schizophrenia-spectrum disorder. RT was delivered over a maximum of 16 sessions within 5 months. Blind assessments were conducted at baseline and at 5 and 9 months. Feasibility outcomes were the number of patients recruited and retained, and safety and therapist adherence. The primary endpoint was the distress factor score of the AVH subscale of the Psychotic Symptoms Rating Scales at 9 months. RESULTS Eighty-five of 177 enrolled participants were randomized into RT + TAU (n = 43) or TAU (n = 42). Feasibility was excellent with 87% retention at 9 months, 86% reaching treatment uptake criteria, 98% therapist adherence, and no unexpected serious adverse reactions. Compared to TAU, RT + TAU showed nonsignificant trends toward less AVH distress (b = -2.40, SE = 1.52, p = 0.121, 90% CI (-4.94 to 0.15) and stronger improvement on all but one of the secondary outcomes. CONCLUSION A randomized controlled trial of RT is feasible, safe, and well accepted. Our results provide an encouraging basis to further test the efficacy of RT in a definitive multicenter trial.

中文翻译：

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减少听觉语言幻觉带来的痛苦：一项相关治疗的多中心、平行、单盲、随机对照可行性试验。


引言 对减少与幻听 （AVH） 相关的痛苦的干预措施有很大的需求。AVH 痛苦与语音听者与 AVH 的关系方式有关。我们旨在确定一项随机对照试验的可行性，以证明在常规治疗 （TAU） 中加入 “相关疗法” （RT） 在减少 AVH 痛苦方面优于 TAU。方法 我们在德国的 5 个心理健康中心进行了一项多中心、平行、单盲、随机对照可行性试验。参与者年龄≥19岁，患有持续性和令人痛苦的AVH，并被诊断为精神分裂症谱系障碍。RT 在 5 个月内最多进行 16 次给药。在基线以及 5 个月和 9 个月时进行盲法评估。可行性结果是招募和保留的患者数量，以及安全性和治疗师依从性。主要终点是 9 个月时精神病症状评定量表的 AVH 分量表的痛苦因素评分。结果 177 名登记参与者中有 85 名被随机分配到 RT + TAU （n = 43） 或 TAU （n = 42）。可行性非常好，9 个月时保留率为 87%，86% 达到治疗接受标准，治疗师依从性为 98%，并且没有意外的严重不良反应。与 TAU 相比，RT + TAU 显示出 AVH 痛苦减少的无统计学趋势 （b = -2.40，SE = 1.52，p = 0.121,90% CI （-4.94 至 0.15），除一个次要结局外，所有次要结局均有更强的改善。结论 RT 的随机对照试验是可行的、安全的，并且被广泛接受。我们的结果为在确定性多中心试验中进一步测试 RT 的疗效提供了令人鼓舞的基础。