@文章{info:doi/ 10.296 /29154，作者="Ghaemi, S Nassir和Sverdlov, Oleksandr和van Dam, Joris和Campellone, Timothy和Gerwien, Robert"，标题="基于智能手机的干预作为精神分裂症标准护理治疗的辅助:随机对照试验"，期刊="JMIR Form Res"，年="2022"，月="3"，日="28"，卷="6"，数="3"，页数="e29154"，关键词="数字治疗;精神分裂症;智能手机;随机对照试验;背景:抗精神病药物对精神分裂症的疗效有限，认知行为疗法可能是一种有益的辅助疗法。除了标准的抗精神病药物外，还有可能实施基于移动认知行为疗法的精神分裂症治疗。目的:本研究旨在确定基于智能手机的研究性数字疗法PEAR-004添加到标准治疗方案中是否能改善精神分裂症急性精神病发作的症状。方法:这是一项为期12周、多中心、随机、假对照、评分盲法、平行组概念证明研究，研究对象为112名精神分裂症中度急性精神病加重患者。该研究于2018年12月至2019年9月在美国的6个临床试验研究地点进行。主要结局，阳性和阴性综合征量表(PANSS)从基线到第12周或最后一次访问的变化，使用重复测量的混合效应回归模型进行分析，应用于意向治疗样本。 Results: The total PANSS scores slightly decreased from baseline over the study period in both groups; the treatment difference at day 85 between PEAR-004 and sham was 2.7 points, in favor of the sham (2-sided P=.09). The secondary scales found no benefit, except for transient improvement in depressive symptoms with PEAR-004. Application engagement was good, and patient and clinical investigator satisfaction was high. No safety concerns were observed. There was some evidence of study site heterogeneity for the onboarding processes and directions on PEAR-004 product use at baseline and throughout the study. However, these differences did not affect the efficacy results. Conclusions: In the largest-to-date randomized, sham-controlled study of a digital therapeutic in schizophrenia, PEAR-004 did not demonstrate an effect on the primary outcome---total PANSS scores---when compared with a nonspecific digital sham control. The secondary and exploratory results also did not demonstrate any notable benefits, except for possible temporary improvement in depressive symptoms. This study provided many useful scientific and operational insights that can be used in the further clinical development of PEAR-004 and other investigational digital therapeutics. Trial Registration: ClinicalTrials.gov NCT03751280; https://clinicaltrials.gov/ct2/show/NCT03751280 ", issn="2561-326X", doi="10.2196/29154", url="https://formative.www.mybigtv.com/2022/3/e29154", url="https://doi.org/10.2196/29154", url="http://www.ncbi.nlm.nih.gov/pubmed/35343910" }