Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.