TY - JOUR AU - Lobban, Fiona AU - Dodd, Alyson L AU - Sawczuk, Adam P AU - Asar, Ozgur AU - Dagnan, Dave AU - Diggle, Peter J AU - Griffiths, Martin AU - Honary, Mahsa AU - Knowles, Dawn AU - Long, Rita AU - Morriss, Richard AU - Parker, Rob AU - Jones, Steven PY - 2017 DA - 2017/03/24 TI -评估基于web的增强双相情感障碍复发预防的可行性和可接受性(ERPonline):一项随机对照试验研究背景:双相情感障碍(BD)患者认识和应对复发早期预警信号(EWS)的干预措施被推荐，但在临床实践中的实施情况很差。目的:本研究的目的是测试一项随机对照试验(RCT)的可行性和可接受性，以评估基于网络的增强复发预防干预(ERPonline)，并报告其有效性的初步证据。方法:一项为期48周的单盲、平行、主要在线随机对照试验(n=96)，比较通过国家卫生服务(NHSs)、志愿组织和媒体招募的双相障碍患者的ERPonline加常规治疗与“候补名单(WL)对照”加常规治疗。随机化是独立的，最小化既往事件数(<8、8-20、21+)。主要结局是招募率和保留率、干预措施使用水平、不良事件和参与者反馈。通过电话和网络评估过程和临床结果，并使用意向治疗分析的线性模型进行比较。结果:共有280人在线注册，其中96人符合纳入标准，同意，并在17个月内随机分配(49人到WL, 47人到ERPonline)，除第48周(76%)外，所有时间点的电话和在线随访保留率为80%。erp在线方法和试验方法的可接受性都很高。ERPonline的创建成本约为19340英镑，每年托管和维护网站的成本约为2176英镑。 Qualitative data highlighted the importance of the relationship that the users have with Web-based interventions. Differences between the group means suggested that access to ERPonline was associated with: a more positive model of BD at 24 weeks (10.70, 95% CI 0.90 to 20.5) and 48 weeks (13.1, 95% CI 2.44 to 23.93); increased monitoring of EWS of depression at 48 weeks (−1.39, 95% CI −2.61 to −0.163) and of hypomania at 24 weeks (−1.72, 95% CI −2.98 to −0.47) and 48 weeks (−1.61, 95% CI −2.92 to −0.30), compared with WL. There was no evidence of impact of ERPonline on clinical outcomes or medication adherence, but relapse rates across both arms were low (15%) and the sample remained high functioning throughout. One person died by suicide before randomization and 5 people in ERPonline and 6 in WL reported ideas of suicide or self-harm. None were deemed study related by an independent Trial Steering Committee (TSC). Conclusions: ERPonline offers a cheap accessible option for people seeking ongoing support following successful treatment. However, given high functioning and low relapse rates in this study, testing clinical effectiveness for this population would require very large sample sizes. Building in human support to use ERPonline should be considered. Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN): 56908625; http://www.isrctn.com/ISRCTN56908625 (Archived by WebCite at http://www.webcitation.org/6of1ON2S0) SN - 1438-8871 UR - //www.mybigtv.com/2017/3/e85/ UR - https://doi.org/10.2196/jmir.7008 UR - http://www.ncbi.nlm.nih.gov/pubmed/28341619 DO - 10.2196/jmir.7008 ID - info:doi/10.2196/jmir.7008 ER -