Psychosis often causes significant distress and impacts not only in the individuals, but also those close to them. Many relatives and friends (‘carers’) provide long-term support and need resources to assist them. We have co-produced a digital mental health intervention called COPe-support (Carers fOr People with Psychosis e-support) to provide carers with flexible access to high quality psychoeducation and interactive support from experts and peers. This study evaluates the effectiveness of COPe-support to promote mental wellbeing and caregiving experiences in carers. This study is a single-blind, parallel arm, individually randomized controlled trial (RCT) comparing COPe-support, with attention control. Both groups continue to receive usual care. COPe-support provides interactive web-based psychoeducation on psychosis-related issues, wellbeing-promotion and network support through forums. The attention-control is a non-interactive online information resource pack. Carers living in England are eligible if they provide at least weekly support to a family member or close friend affected by psychosis, and use internet communication (including emails) daily. All trial procedures are run online, including collection of outcome measurements which participants will directly input into our secure platform. Following baseline assessment, a web-based randomization system will be used to allocate 360 carers to either arm. Participants have unlimited access to the allocated condition for 40 weeks. Data collection is at three time points (10, 20, and 40 weeks after randomization). Analyses will be conducted by trial statisticians blinded to allocation. The primary outcome is mental wellbeing measured by Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), at 20 weeks. As well as an intention-to-treat analysis, a complier average causal effect (CACE) analysis will be conducted to estimate the intervention effect in participants who have accessed COPe-support content twice or more. The secondary objectives and analysis will examine other health and caregiving-related outcomes and explore mechanisms. In a process evaluation, we will interview 20% of the intervention arm participants regarding the acceptability of COPe-support. We will explore in detail participants’ usage patterns. The results of this trial will provide valuable information about the effectiveness of COPe-support in promoting wellbeing and caregiving experiences in carers. The RCT is registered with the Current Controlled Trials registration (ISRCTN 89563420, registration date: 02/03/2018).

中文翻译：

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COPe支持-针对精神病患者的家庭护理人员的多组分数字干预：一项随机对照试验的研究方案。

精神病不仅会给个人造成严重的困扰，而且还会影响亲人。许多亲戚和朋友（“照顾者”）提供长期支持，需要资源来帮助他们。我们与他人共同制作了一种名为COPe-support（精神病患者的照护者电子支持）的数字心理健康干预措施，以使护理者可以灵活地获得高质量的心理教育，并获得专家和同行的互动支持。这项研究评估了COPe支持在促进护理人员心理健康和护理方面的有效性。这项研究是一项单盲，平行臂，独立随机对照试验（RCT），将COPe支持与注意控制进行了比较。两组均继续接受常规护理。COPe支持人员针对与精神病相关的问题提供基于网络的交互式心理教育，通过论坛提供福利和网络支持。注意控件是一个非交互式的在线信息资源包。如果居住在英格兰的看护者至少每周向遭受精神病困扰的家庭成员或密友提供支持，并且每天使用互联网通信（包括电子邮件），则有资格参加。所有试用程序均在线运行，包括收集结果测量值，参与者将其直接输入到我们的安全平台中。在进行基线评估后，将使用基于网络的随机系统将360名护理人员分配给任一部门。参与者可以在40周内无限制地使用分配的条件。在三个时间点（随机分组后的10、20和40周）收集数据。分析将由不愿分配的试验统计人员进行。主要结果是在20周时通过Warwick Edinburgh心理健康量表（WEMWBS）衡量的心理健康。除了意向性治疗分析之外，还将进行Complier平均因果效应（CACE）分析，以评估两次或多次访问COPe支持内容的参与者的干预效果。次要目标和分析将检查其他与健康和护理相关的结果并探索机制。在过程评估中，我们将就COPe支持的可接受性采访20％的干预部门参与者。我们将详细探讨参与者的使用模式。该试验的结果将提供有关COPe支持在促进护理人员幸福感和护理方面的有效性的有价值的信息。