Mai Anna, Pape Magdalena, Busse Theresa Sophie, Kunde Katharina, Bosompem Jennifer, Giehl Chantal, Otte Ina Carola, Herpertz Stephan, Juckel Georg, Haussleiter Ida, Wirth Rainer, Vollmar Horst Christian, Timmesfeld Nina, Dieris-Hirche Jan
Department of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, Germany.
Department of Psychosomatic Medicine and Psychotherapy, LWL-University Hospital, Ruhr University Bochum, Bochum, Germany.
Trials. 2025 Apr 10;26(1):130. doi: 10.1186/s13063-025-08809-7.
In the face of extensive waiting times for outpatient psychotherapy, prescriptible digital health applications (DiGA) are a useful and effective addition to the range of available therapy options for patients with mild to moderate depression. However, older adults face a particular challenge in implementing DiGA since higher age is a decisive predictor of lower digital health literacy. The necessity of an independent use of the prescribed DiGA is therefore associated with challenges for older patients and providers. In practice, it is crucial not to leave patients, especially older adults, alone after prescribing, but to maintain close contact to overcome technical and motivational barriers and to ensure that the novel application is used. However, this is difficult for physicians and psychotherapists due to the critical healthcare system situation in Germany described above. Another support system is needed. Hence, the main hypothesis of this study is that the additional implementation of digital nurses leads to a higher percentage of older patients with depressive symptoms starting DiGA use compared to a prescription and information alone.
Two DiGA for mild to moderate depression in older patients were available and permanently approved at the time of the funding application. Using the most suitable one of them, as shown in a pilot study, the feasibility of implementation will be examined within a randomized proof of concept study. In our study, a digital nurse is trained to support patients with depression in using a DiGA. The main outcome is DiGA use (first session started: yes/no) after 8 weeks. Major secondary outcomes are patient-relevant outcomes, feasibility of recruitment and intervention, and factors moderating the effect or predicting DiGA use in the target group. Best practice guidelines will be elaborated on how to support and improve DiGA prescription and successful use in this population.
In Germany, the approved DiGA are currently little used, especially by people with a low digital affinity. This proof of concept study will use the example of older people with depressive disorders to show whether it is possible to increase the usage rate of a DiGA with the support of a digital nurse so that a DiGA can become a serious therapy option.
DRKS: DRKS00033535. Registered on February 2, 2024.
面对门诊心理治疗漫长的等待时间,可开具处方的数字健康应用程序(DiGA)对于轻度至中度抑郁症患者而言,是现有治疗选择范围中有益且有效的补充。然而,老年人在使用DiGA时面临特殊挑战,因为年龄较大是数字健康素养较低的决定性预测因素。因此,独立使用处方DiGA的必要性给老年患者和医疗服务提供者带来了挑战。在实践中,至关重要的是在开出处方后不要让患者,尤其是老年患者独自面对,而是要保持密切联系,以克服技术和动机障碍,并确保使用这种新应用程序。然而,由于上述德国严峻的医疗系统状况,这对医生和心理治疗师来说很困难。需要另一种支持系统。因此,本研究的主要假设是,与仅开具处方和提供信息相比,额外配备数字护士会使更多有抑郁症状的老年患者开始使用DiGA。
在申请资助时,有两种用于老年患者轻度至中度抑郁症的DiGA可供使用且已永久获批。如一项试点研究所示,使用其中最合适的一种,将在一项随机概念验证研究中检验实施的可行性。在我们的研究中,培训一名数字护士来支持抑郁症患者使用DiGA。主要结局是8周后DiGA的使用情况(是否开始首次疗程)。主要次要结局是与患者相关的结局、招募和干预的可行性以及调节目标人群中DiGA使用效果或预测DiGA使用的因素。将制定最佳实践指南,说明如何支持和改善该人群中DiGA的处方开具及成功使用。
在德国,目前获批的DiGA使用较少,尤其是数字亲和力较低的人群。这项概念验证研究将以患有抑郁症的老年人为例,表明在数字护士的支持下是否有可能提高DiGA的使用率,从而使DiGA成为一种切实可行的治疗选择。
DRKS:DRKS00033535。于2024年2月2日注册。