基于网络的同伴支持自我管理干预对精神分裂症或双相障碍患者亲属的临床效果（REACT）：在线、观察盲、随机对照优势试验。
Clinical effectiveness of a web-based peer-supported self-management intervention for relatives of people with psychosis or bipolar (REACT): online, observer-blind, randomised controlled superiority trial.
机构信息
Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.
Clinical Trials Research Centre, Institute of Child Health, Alder Hey, University of Liverpool, Liverpool, UK.
出版信息
BMC Psychiatry. 2020 Apr 14;20(1):160. doi: 10.1186/s12888-020-02545-9.
BACKGROUND
The Relatives Education And Coping Toolkit (REACT) is an online supported self-management toolkit for relatives of people with psychosis or bipolar designed to improve access to NICE recommended information and emotional support.
AIMS
Our aim was to determine clinical and cost-effectiveness of REACT including a Resource Directory (RD), versus RD-only.
METHODS
A primarily online, observer-blind randomised controlled trial comparing REACT (including RD) with RD only (registration ISRCTN72019945). Participants were UK relatives aged > = 16, with high distress (assessed using the GHQ-28), and actively help-seeking, individually randomised, and assessed online. Primary outcome was relatives' distress (GHQ-28) at 24 weeks. Secondary outcomes were wellbeing, support, costs and user feedback.
RESULTS
We recruited 800 relatives (REACT = 399; RD only = 401) with high distress at baseline (GHQ-28 REACT mean 40.3, SD 14.6; RD only mean 40.0, SD 14.0). Median time spent online on REACT was 50.8 min (IQR 12.4-172.1) versus 0.5 min (IQR 0-1.6) on RD only. Retention to primary follow-up (24 weeks) was 75% (REACT n = 292 (73.2%); RD-only n = 307 (76.6%)). Distress decreased in both groups by 24 weeks, with no significant difference between the two groups (- 1.39, 95% CI -3.60, 0.83, p = 0.22). Estimated cost of delivering REACT was £62.27 per person and users reported finding it safe, acceptable and convenient. There were no adverse events or reported side effects.
CONCLUSIONS
REACT is an inexpensive, acceptable, and safe way to deliver NICE-recommended support for relatives. However, for highly distressed relatives it is no more effective in reducing distress (GHQ-28) than a comprehensive online resource directory.
TRIAL REGISTRATION
ISRCTN72019945 prospectively registered 19/11/2015.
背景
亲属教育和应对工具包（REACT）是一种在线支持的自我管理工具包，适用于精神分裂症或双相情感障碍患者的亲属，旨在改善获得 NICE 推荐信息和情感支持的机会。
目的
我们的目的是确定 REACT（包括资源目录（RD））与仅 RD 的临床和成本效益。
方法
一项主要在线、观察者盲随机对照试验，比较了 REACT（包括 RD）与仅 RD（注册 ISRCTN72019945）。参与者为年龄≥16 岁的英国亲属，有高度困扰（使用 GHQ-28 评估），积极寻求帮助，进行个体随机分组，并在线评估。主要结局是 24 周时亲属的困扰（GHQ-28）。次要结局是幸福感、支持、成本和用户反馈。
结果
我们招募了 800 名有高困扰的亲属（REACT=399；仅 RD=401），基线时 GHQ-28 评分较高（REACT 平均 40.3，SD 14.6；仅 RD 平均 40.0，SD 14.0）。REACT 在线时间中位数为 50.8 分钟（IQR 12.4-172.1），而 RD 仅为 0.5 分钟（IQR 0-1.6）。主要随访（24 周）的保留率为 75%（REACT n=292（73.2%）；RD-only n=307（76.6%））。两组在 24 周时困扰均有所减轻，两组之间无显著差异（-1.39，95%CI-3.60，0.83，p=0.22）。REACT 的估计交付成本为每人 62.27 英镑，用户报告发现它安全、可接受和方便。没有不良事件或报告的副作用。
结论
REACT 是一种廉价、可接受和安全的方式，可以为亲属提供 NICE 推荐的支持。然而，对于高度困扰的亲属来说，它在减轻困扰（GHQ-28）方面并不比综合在线资源目录更有效。
试验注册
ISRCTN72019945 于 2015 年 11 月 19 日前瞻性注册。
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