Background

Early warning signs monitoring by service users with schizophrenia has shown promise in preventing relapse but the quality of evidence is low. We aimed to establish the feasibility of undertaking a definitive randomised controlled trial to determine the effectiveness of a blended digital intervention for relapse prevention in schizophrenia.

Methods

This multicentre, feasibility, cluster randomised controlled trial aimed to compare Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) with treatment as usual in community mental health services (CMHS) in Glasgow and Melbourne. CMHS were the unit of randomisation, selected on the basis of those that probably had five or more care coordinators willing to participate. Participants were eligible if they were older than 16 years, had a schizophrenia or related diagnosis confirmed via case records, were able to provide informed consent, had contact with CMHS, and had had a relapse within the previous 2 years. Participants were randomised within stratified clusters to EMPOWER or to continue their usual approach to care. EMPOWER blended a smartphone for active monitoring of early warning signs with peer support to promote self-management and clinical triage to promote access to relapse prevention. Main outcomes were feasibility, acceptability, usability, and safety, which was assessed through face-to-face interviews. App usage was assessed via the smartphone and self-report. Primary end point was 12 months. Participants, research assistants and other team members involved in delivering the intervention were not masked to treatment conditions. Assessment of relapse was done by an independent adjudication panel masked to randomisation group. The study is registered at ISRCTN (99559262).

Findings

We identified and randomised eight CMHS (six in Glasgow and two in Melbourne) comprising 47 care coordinators. We recruited 86 service users between Jan 19 and Aug 8, 2018; 73 were randomised (42 [58%] to EMPOWER and 31 [42%] to treatment as usual). There were 37 (51%) men and 36 (49%) women. At 12 months, main outcomes were collected for 32 (76%) of service users in the EMPOWER group and 30 (97%) of service users in the treatment as usual group. Of those randomised to EMPOWER, 30 (71%) met our a priori criterion of more than 33% adherence to daily monitoring that assumed feasibility. Median time to discontinuation of these participants was 31·5 weeks (SD 14·5). There were 29 adverse events in the EMPOWER group and 25 adverse events in the treatment as usual group. There were 13 app-related adverse events, affecting 11 people, one of which was serious. Fear of relapse was lower in the EMPOWER group than in the treatment as usual group at 12 months (mean difference –7·53 (95% CI –14·45 to 0·60; Cohen's d –0·53).

Interpretation

A trial of digital technology to monitor early warning signs blended with peer support and clinical triage to detect and prevent relapse appears to be feasible, safe, and acceptable. A further main trial is merited.

Funding

UK National Institute for Health Research Health Technology Assessment programme and the Australian National Health and Medical Research Council.

中文翻译：

---

EMPOWER 混合数字干预预防精神分裂症复发：苏格兰和澳大利亚的可行性集群随机对照试验

背景

对精神分裂症服务使用者进行的早期预警信号监测已显示出预防复发的希望，但证据质量较低。我们的目的是确定进行最终随机对照试验的可行性，以确定混合数字干预对精神分裂症复发预防的有效性。

方法

这项多中心、可行性、整群随机对照试验旨在比较早期迹象监测以防止精神病复发并促进幸福、参与和康复 (EMPOWER) 与格拉斯哥和墨尔本社区心理健康服务 (CMHS) 的常规治疗。CMHS 是随机化的单位，根据可能有五个或更多护理协调员愿意参与的人员进行选择。如果参与者年龄超过 16 岁，通过病例记录确认患有精神分裂症或相关诊断，能够提供知情同意，与 CMHS 有联系，并且在过去 2 年内复发，则参与者符合条件。参与者在分层集群中被随机分配到 EMPOWER 或继续他们通常的护理方法。EMPOWER 将用于主动监测早期预警信号的智能手机与同伴支持相结合，以促进自我管理和临床分诊，从而促进获得预防复发的机会。主要结果是可行性、可接受性、可用性和安全性，通过面对面访谈进行评估。应用程序使用情况通过智能手机和自我报告进行评估。主要终点为 12 个月。参与实施干预的参与者、研究助理和其他团队成员没有隐瞒治疗条件。复发的评估是由一个对随机分组不知情的独立裁决小组进行的。该研究已在 ISRCTN (99559262) 注册。这是通过面对面的访谈进行评估的。应用程序使用情况通过智能手机和自我报告进行评估。主要终点为 12 个月。参与实施干预的参与者、研究助理和其他团队成员没有隐瞒治疗条件。复发的评估是由一个对随机分组不知情的独立裁决小组进行的。该研究已在 ISRCTN (99559262) 注册。这是通过面对面的访谈进行评估的。应用程序使用情况通过智能手机和自我报告进行评估。主要终点为 12 个月。参与实施干预的参与者、研究助理和其他团队成员没有隐瞒治疗条件。复发的评估是由一个对随机分组不知情的独立裁决小组进行的。该研究已在 ISRCTN (99559262) 注册。

发现

我们确定并随机分配了 8 个 CMHS（6 个在格拉斯哥，2 个在墨尔本），包括 47 名护理协调员。我们在 2018 年 1 月 19 日至 8 月 8 日期间招募了 86 名服务用户；73 人被随机分配（42 人 [58%] 接受 EMPOWER 治疗，31 人 [42%] 接受常规治疗）。有 37 名 (51%) 男性和 36 名 (49%) 女性。在 12 个月时，收集了 EMPOWER 组 32 名（76%）服务用户和照常治疗组 30 名（97%）服务用户的主要结果。在随机分配到 EMPOWER 的患者中，30 人 (71%) 符合我们的先验标准，即 33% 以上的人坚持假设可行的日常监测。这些参与者的中位停药时间为 31·5 周 (SD 14·5)。EMPOWER组有29起不良事件，照常治疗组有25起不良事件。有 13 起与应用程序相关的不良事件，影响了 11 人，其中之一是严重的。在 12 个月时，EMPOWER 组对复发的恐惧低于照常治疗组（平均差 –7·53（95% CI –14·45 至 0·60；Cohen'sd –0·53)。

解释

一项监测早期预警信号的数字技术试验与同伴支持和临床分诊相结合以检测和预防复发似乎是可行、安全和可接受的。值得进行进一步的主要试验。

资金

英国国家卫生研究院卫生技术评估计划和澳大利亚国家卫生与医学研究委员会。