Glasgow Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Glasgow Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Lancet Psychiatry. 2022 Jun;9(6):477-486. doi: 10.1016/S2215-0366(22)00103-1.
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.
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).
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).
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.
UK National Institute for Health Research Health Technology Assessment programme and the Australian National Health and Medical Research Council.
服务使用者对精神分裂症的早期预警信号监测显示，该方法有望预防复发，但证据质量较低。我们旨在确定开展一项确定的随机对照试验的可行性，以确定针对精神分裂症复发预防的混合数字干预的有效性。
这项多中心、可行性、集群随机对照试验旨在比较早期预警信号监测以预防精神病复发和促进幸福感、参与度和康复（EMPOWER）与常规社区精神卫生服务（CMHS）中的常规治疗。CMHS 是随机分组的单位，根据可能有五个或更多护理协调员愿意参与的单位进行选择。如果参与者年龄在 16 岁以上，通过病历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 年内有过复发，则有资格参加。参与者按照分层聚类随机分配到 EMPOWER 组或继续接受常规护理。EMPOWER 将智能手机用于主动监测早期预警信号，并结合同伴支持来促进自我管理和临床分诊，以促进预防复发。主要结局是可行性、可接受性、可用性和安全性，这些都是通过面对面访谈来评估的。应用程序的使用情况通过智能手机和自我报告进行评估。主要终点是 12 个月。参与提供干预措施的参与者、研究助理和其他团队成员没有对治疗条件进行屏蔽。复发的评估是由一个独立的裁决小组进行的，该小组对随机分组情况进行了屏蔽。该研究在 ISRCTN 注册（ISRCTN99559262）。
我们确定并随机分配了包括 47 名护理协调员在内的 8 个 CMHS（6 个在格拉斯哥，2 个在墨尔本）。我们在 2018 年 1 月 19 日至 8 月 8 日期间招募了 86 名服务使用者；73 名被随机分配（42[58%]为 EMPOWER，31[42%]为常规治疗）。其中 37 名（51%）为男性，36 名（49%）为女性。在 12 个月时，EMPOWER 组的 32 名（76%）和常规治疗组的 30 名（97%）服务使用者都收集了主要结局。在被分配到 EMPOWER 的参与者中，有 30 名（71%）达到了我们假设可行的每日监测超过 33%的依从性的预先确定标准。这些参与者的中位停药时间为 31.5 周（SD 14.5）。EMPOWER 组有 29 例不良事件，常规治疗组有 25 例不良事件。EMPOWER 组有 13 例与应用程序相关的不良事件，影响 11 人，其中 1 例为严重不良事件。与常规治疗组相比，EMPOWER 组在 12 个月时的复发恐惧程度较低（平均差值-7.53[95%CI-14.45 至 0.60；Cohen's d-0.53）。
一项针对精神分裂症早期预警信号监测的数字技术试验，结合同伴支持和临床分诊，以检测和预防复发，似乎是可行的、安全的和可接受的。值得开展进一步的主要试验。
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理事会。
