Suicide is a leading cause of death globally. Suicide deaths are elevated in those experiencing severe mental health problems, including schizophrenia. Psychological talking therapies are a potentially effective means of alleviating suicidal thoughts, plans, and attempts. However, talking therapies need to i) focus on suicidal experiences directly and explicitly, and ii) be based on testable psychological mechanisms. The Cognitive AppRoaches to coMbatting Suicidality (CARMS) project is a Randomised Controlled Trial (RCT) which aims to investigate both the efficacy and the underlying mechanisms of a psychological talking therapy for people who have been recently suicidal and have non-affective psychosis. The CARMS trial is a two-armed single-blind RCT comparing a psychological talking therapy (Cognitive Behavioural Suicide Prevention for psychosis [CBSPp]) plus Treatment As Usual (TAU) with TAU alone. There are primary and secondary suicidality outcome variables, plus mechanistic, clinical, and health economic outcomes measured over time. The primary outcome is a measure of suicidal ideation at 6 months after baseline. The target sample size is 250, with approximately 125 randomised to each arm of the trial, and an assumption of up to 25% attrition. Hence, the overall recruitment target is up to 333. An intention to treat analysis will be used with primary stratification based on National Health Service (NHS) recruitment site and antidepressant prescription medication. Recruitment will be from NHS mental health services in the North West of England, UK. Participants must be 18 or over; be under the care of mental health services; have mental health problems which meet ICD-10 non-affective psychosis criteria; and have experienced self-reported suicidal thoughts, plans, and/or attempts in the 3 months prior to recruitment. Nested qualitative work will investigate the pathways to suicidality, experiences of the therapy, and identify potential implementation challenges beyond a trial setting as perceived by numerous stake-holders. This trial has important implications for countering suicidal experiences for people with psychosis. It will provide definitive evidence about the efficacy of the CBSPp therapy; the psychological mechanisms which lead to suicidal experiences; and provide an understanding of what is required to implement the intervention into services should it be efficacious. ClinicalTrials.gov (NCT03114917), 14th April 2017. ISRCTN (reference ISRCTN17776666 https://doi.org/10.1186/ISRCTN17776666); 5th June 2017). Registration was recorded prior to participant recruitment commencing.

中文翻译：

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适用于非情感性精神病的自杀心理干预：CARMS（对抗自杀的认知方法）随机对照试验方案。

自杀是全球死亡的主要原因。那些患有严重精神健康问题（包括精神分裂症）的人自杀死亡人数较高。心理谈话疗法是减轻自杀念头、计划和企图的潜在有效方法。然而，谈话疗法需要 i) 直接、明确地关注自杀经历，ii) 基于可测试的心理机制。对抗自杀的认知方法 (CARMS) 项目是一项随机对照试验 (RCT)，旨在研究心理谈话疗法对最近有自杀倾向和非情感性精神病患者的疗效和潜在机制。CARMS 试验是一项双组单盲随机对照试验，比较心理谈话疗法（精神病认知行为自杀预防 [CBSPp]）加常规治疗 (TAU) 与单独使用 TAU。有主要和次要的自杀结果变量，以及随着时间的推移测量的机械、临床和健康经济结果。主要结局是基线后 6 个月时自杀意念的测量。目标样本量为 250 个，其中大约 125 个随机分配到试验的每个组，并假设流失率高达 25%。因此，总体招募目标为 333 名。将根据国家医疗服务体系 (NHS) 招募地点和抗抑郁处方药进行初步分层，进行意向治疗分析。招募人员将从英国英格兰西北部的 NHS 心理健康服务机构进行。参加者必须年满18岁；接受心理健康服务机构的照顾；存在符合 ICD-10 非情感性精神病标准的心理健康问题；并在招募前 3 个月内自我报告有自杀想法、计划和/或尝试。嵌套定性工作将调查自杀的途径、治疗经历，并确定众多利益相关者认为超出试验环境的潜在实施挑战。这项试验对于对抗精神病患者的自杀经历具有重要意义。它将提供关于 CBSPp 疗法疗效的明确证据；导致自杀经历的心理机制；并了解如果干预措施有效，需要采取哪些措施来实施服务干预。ClinicalTrials.gov (NCT03114917)，2017 年 4 月 14 日。ISRCTN（参考 ISRCTN17776666 https://doi.org/10.1186/ISRCTN17776666）；2017 年 6 月 5 日）。在参与者招募开始之前记录注册。