NEVERMIND电子健康系统治疗严重躯体疾病患者的抑郁症状：一项多中心、实用性随机对照试验。
The NEVERMIND e-health system in the treatment of depressive symptoms among patients with severe somatic conditions: A multicentre, pragmatic randomised controlled trial.
作者信息
Carli Vladimir, Petros Nuhamin Gebrewold, Hadlaczky Gergö, Vitcheva Tereza, Berchialla Paola, Bianchi Silvia, Carletto Sara, Christinaki Eirini, Citi Luca, Dinis Sérgio, Gentili Claudio, Geraldes Vera, Giovinazzo Lorena, Gonzalez-Martinez Sergio, Meyer Björn, Ostacoli Luca, Ottaviano Manuel, Ouakinin Silvia, Papastylianou Tasos, Paradiso Rita, Poli Riccardo, Rocha Isabel, Settanta Carmen, Scilingo Enzo Pasquale, Valenza Gaetano
机构信息
National Centre for Suicide Research and Prevention of Mental Ill-Health, Karolinska Institutet, Stockholm, Sweden.
Department of Clinical and Biological Sciences, Università degli Studi di Torino, Turin, Italy.
出版信息
EClinicalMedicine. 2022 May 6;48:101423. doi: 10.1016/j.eclinm.2022.101423. eCollection 2022 Jun.
BACKGROUND
This study assessed the effectiveness of the NEVERMIND e-health system, consisting of a smart shirt and a mobile application with lifestyle behavioural advice, mindfulness-based therapy, and cognitive behavioural therapy, in reducing depressive symptoms among patients diagnosed with severe somatic conditions. Our hypothesis was that the system would significantly decrease the level of depressive symptoms in the intervention group compared to the control group.
METHODS
This pragmatic, randomised controlled trial included 425 patients diagnosed with myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants were recruited from hospitals in Turin and Pisa (Italy), and Lisbon (Portugal), and were randomly assigned to either the NEVERMIND intervention or to the control group. Clinical interviews and structured questionnaires were administered at baseline, 12 weeks, and 24 weeks. The primary outcome was depressive symptoms at 12 weeks measured by the Beck Depression Inventory II (BDI-II). Intention-to-treat analyses included 425 participants, while the per-protocol analyses included 333 participants. This trial is registered in the German Clinical Trials Register, DRKS00013391.
FINDINGS
Patients were recruited between Dec 4, 2017, and Dec 31, 2019, with 213 assigned to the intervention and 212 to the control group. The sample had a mean age of 59·41 years (SD=10·70), with 44·24% women. Those who used the NEVERMIND system had statistically significant lower depressive symptoms at the 12-week follow-up (mean difference=-3·03, <0·001; 95% CI -4·45 to -1·62) compared with controls, with a clinically relevant effect size (Cohen's =0·39).
INTERPRETATION
The results of this study show that the NEVERMIND system is superior to standard care in reducing and preventing depressive symptoms among patients with the studied somatic conditions.
FUNDING
The NEVERMIND project received funding from the European Union's Horizon 2020 Research and Innovation Programme under grant agreement No. 689691.
背景
本研究评估了NEVERMIND电子健康系统的有效性，该系统由一件智能衬衫和一个移动应用程序组成，提供生活方式行为建议、正念疗法和认知行为疗法，用于减轻被诊断患有严重躯体疾病患者的抑郁症状。我们的假设是，与对照组相比，该系统将显著降低干预组的抑郁症状水平。
方法
这项实用的随机对照试验纳入了425名被诊断患有心肌梗死、乳腺癌、前列腺癌、肾衰竭或下肢截肢的患者。参与者从意大利都灵和比萨以及葡萄牙里斯本的医院招募，并被随机分配到NEVERMIND干预组或对照组。在基线、12周和24周时进行临床访谈和结构化问卷调查。主要结局是12周时用贝克抑郁量表第二版（BDI-II）测量的抑郁症状。意向性分析包括425名参与者，符合方案分析包括333名参与者。该试验已在德国临床试验注册中心注册，注册号为DRKS00013391。
结果
患者于2017年12月4日至2019年12月31日招募，213人被分配到干预组，212人被分配到对照组。样本的平均年龄为59.41岁（标准差=10.70），女性占44.24%。与对照组相比，使用NEVERMIND系统的患者在12周随访时抑郁症状在统计学上显著更低（平均差异=-3.03，<0.001；95%置信区间-4.45至-1.62），具有临床相关的效应量（科恩氏d=0.39）。
解读
本研究结果表明，NEVERMIND系统在减轻和预防所研究的躯体疾病患者的抑郁症状方面优于标准护理。
资金
NEVERMIND项目获得了欧盟地平线2020研究与创新计划的资助，资助协议编号为689691。
Zotero 插件