Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder--the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial.
Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder--the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial.
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DOI：
10.1136/bmjopen-2013-003353
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发表时间：
2013
期刊：
影响因子：
2.9
通讯作者：
Kessing LV
中科院分区：
文献类型：
--
作者：
Faurholt-Jepsen M;Vinberg M;Christensen EM;Frost M;Bardram J;Kessing LV
建议使用手机对情感症状进行电子自我监测，作为监测疾病活动和识别情感症状早期迹象的一种实用且廉价的方法。电子自我监测是否能改善双相情感障碍的预后，从未在随机临床试验中进行过测试。我们正在进行一项试验，测试在双相情感障碍中使用智能手机进行自我监控的效果。我们为基于android的智能手机开发了MONARCA应用程序，允许患有双相情感障碍的患者进行日常自我监测，包括通过基于网络的界面在患者和临床医生之间进行互动反馈循环。应用程序的效果在一项平行组单盲随机对照试验中进行了测试，其中包括78名年龄在18-60岁的双相情感障碍患者，他们在6个月的研究期间使用带有MONARCA应用程序的智能手机（干预组）或使用没有应用程序的手机（安慰剂组）。这项研究从2011年9月开始进行。结果是情感症状（初级）、社会功能、感知压力、自评抑郁和躁狂症状、生活质量、药物依从性、压力和认知功能（二级和三级）的变化。招聘正在进行中。已获得伦理许可。将公布研究的正面、中性和负面结果。该试验已获得丹麦首都地区伦理委员会（H-2-2011-056）和丹麦数据保护局（2013-411-1710）的批准。该试验在ClinicalTrials.gov注册为NCT01446406。
Electronic self-monitoring of affective symptoms using cell phones is suggested as a practical and inexpensive way to monitor illness activity and identify early signs of affective symptoms. It has never been tested in a randomised clinical trial whether electronic self-monitoring improves outcomes in bipolar disorder. We are conducting a trial testing the effect of using a Smartphone for self-monitoring in bipolar disorder. We developed the MONARCA application for Android-based Smartphones, allowing patients suffering from bipolar disorder to do daily self-monitoring—including an interactive feedback loop between patients and clinicians through a web-based interface. The effect of the application was tested in a parallel-group, single-blind randomised controlled trial so far including 78 patients suffering from bipolar disorder in the age group 18–60 years who were given the use of a Smartphone with the MONARCA application (intervention group) or to the use of a cell phone without the application (placebo group) during a 6-month study period. The study was carried out from September 2011. The outcomes were changes in affective symptoms (primary), social functioning, perceived stress, self-rated depressive and manic symptoms, quality of life, adherence to medication, stress and cognitive functioning (secondary and tertiary). Recruitment is ongoing. Ethical permission has been obtained. Positive, neutral and negative findings of the study will be published. The trial is approved by the Regional Ethics Committee in The Capital Region of Denmark (H-2-2011-056) and The Danish Data Protection Agency (2013-41-1710). The trial is registered at ClinicalTrials.gov as NCT01446406.
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影响因子：
5
作者：
COHEN, S;KAMARCK, T;MERMELSTEIN, R
通讯作者：
MERMELSTEIN, R
影响因子：
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Geddes, JR
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