Department of Psychiatry and Neurosciences, CCM, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Dtsch Arztebl Int. 2023 Nov 24;120(47):797-803. doi: 10.3238/arztebl.m2023.0208.
The introduction of digital health applications (DiGA) is a fundamental innovation in Germany. In the field of mental health, numerous applications are already available whose efficacy has been tested in clinical trials. We investigated whether, and to what extent, the use of DiGA can be recommended on the basis of the available evidence.
In this scoping review, we summarize the evidence supporting the use of DiGA in the mental health field through an examination of relevant publications that were retrieved by a systematic literature search. We provide an annotated tabular listing and discuss the current advantages of, and obstacles to, the care of mentally ill patients with the aid of DiGA.
We identified 17 DiGA for use in depression, anxiety disorders, addiction disorders, sleep disorders, stress/burnout, vaginismus, and chronic pain. These DiGA have been evaluated to date in 3 meta-analyses, 39 randomized controlled trials (RCTs), and two single-armed intervention trials. 23 of the 36 published trials were carried out with the direct participation of the manufacturers. 29 of the 39 RCTs were not blinded or contained no information regarding blinding. Active controls were used in 6 of the 39 RCTs. The reported effect sizes, with the exclusion of pre-post analyses, ranged from 0.16 to 1.79.
Most of the published studies display a high risk of bias, both because of the manufacturers' participation and because of methodological deficiencies. DiGA are an increasingly important therapeutic modality in psychiatry. The available evidence indicates that treatment effects are indeed present, but prospective comparisons with established treatments are still entirely lacking.
数字健康应用程序（DiGA）的引入是德国的一项基础创新。在心理健康领域，已经有许多应用程序，其疗效已经在临床试验中得到了验证。我们研究了这些应用程序在现有证据的基础上是否可以被推荐使用，以及在多大程度上可以被推荐使用。
在这项范围界定综述中，我们通过系统文献检索检索到的相关出版物，总结了支持数字健康应用程序在心理健康领域使用的证据。我们提供了一个注释表格列表，并讨论了使用数字健康应用程序在精神疾病患者护理方面的当前优势和障碍。
我们确定了 17 种用于治疗抑郁症、焦虑障碍、成瘾障碍、睡眠障碍、压力/倦怠、阴道痉挛和慢性疼痛的数字健康应用程序。这些数字健康应用程序迄今为止已经在 3 项荟萃分析、39 项随机对照试验（RCT）和 2 项单臂干预试验中进行了评估。36 项已发表的试验中有 23 项是由制造商直接参与完成的。39 项 RCT 中有 29 项没有进行盲法或没有关于盲法的信息。6 项 RCT 中使用了活性对照。排除前后分析后，报告的效应大小范围为 0.16 至 1.79。
大多数已发表的研究显示出较高的偏倚风险，这既与制造商的参与有关，也与方法学上的缺陷有关。数字健康应用程序是精神病学中一种越来越重要的治疗方式。现有证据表明，治疗效果确实存在，但与已确立的治疗方法的前瞻性比较仍然完全缺乏。
