Digital Health applications (DiGA) to support psychological wellbeing – A systematic review protocol

Annika Schmitz, Silke Frey, Ana Luisa Neves, Birgitta Weltermann

Keywords: digital health application, DiGA, review, mental health, depression, study protocol

Background:

Lack of psychological well-being is a frequent cause of GP consultations. For example, depression is a common diagnosis in primary care. Behavioural therapy is effective, as single or group therapy, in a face-to-face or online format, or - more recently - as a digital application. A recent review of 12 international studies showed positive effects of smartphone-app based interventions on middle to severe depression (Serrano-Ripoll 2022). The inSIGHT study showed that 53% of the GPs surveyed prescribed at least one digital health technology for any diagnosis in a 4 month-period during the COVID pandemic (Neves 2019). Since October 2020, digital health applications (DiGA) are a new therapeutic option in Germany, which can be prescribed like a medication. Proof of effectiveness is required for approval by the Federal Institute for Drugs and Medical Devices (BfArM). However, to date, no systematic review has been performed to evaluate the effectiveness of all available DiGA for mental health outcomes.

Research questions:

The aim of the study is to systematically evaluate DiGA for patients with mental health issues, especially depression and anxiety disorder.

Method:

All DiGA addressing mental illnesses listed in the directory will be included in the review. Effectiveness studies provided in the directory and those retrieved from electronic databases will be included. No exclusion criteria for participants will be applied. The systematic analysis is based on various frameworks: 1. general information and expert-based usability will be analysed using the framework of Arnold et al. (2019); 2. intervention effects will be summarized; 3. content and intervention strategies will be described using the behaviour change techniques and theoretical domain framework taxonomy (BCTTv1).

Results:

Data extraction is ongoing. First results will be available at the congress.

Conclusions:

The review will show if the DiGA used in Germany reach a similar level of evidence as comparable international evaluations.

Points for discussion:

Which quality aspects interest you most in digital health applications for your patients’ well-being?

Will you prescribe more digital health applications in the future when their effectiveness is proven by more profound study designs?