Real-world evidence for the use of digital cognitive behavioural therapy for insomnia within primary care: A systematic evaluation of user data

Abstract

Background: The introduction of digital health applications (DiGA) in the German healthcare system has enabled scalable access to guideline-recommended treatment for chronic insomnia. Since October 2020, the DiGA somnio can be prescribed by practitioners and offers digital cognitive-behavioural therapy for insomnia (CBT-I) for patients with an insomnia diagnosis. The availability of user data now enables us to investigate the effects of digital CBT‑I as part of its use in standard care for the first time. Objectives: Analysis of user data derived from the digital CBT‑I intervention somnio will provide a more comprehensive understanding of its impact, benefits, and acceptability within primary care. Materials and methods: We analysed data from N = 5000 randomly selected users who completed somnio between 2021 and 2022 and reported an insomnia severity index (ISI) ≥ 8 at the start of the intervention. Insomnia severity (ISI) and sleep behaviour were evaluated descriptively over the course of the digital intervention. Cohen’s d for within-group changes were calculated to provide information on effect measures. Results: Our analysis revealed a reduction in insomnia severity of −8.49 ± 5.39 points on the ISI between start and end of the program (d = 1.58). At completion, 57% met response criteria (reduction ≥ 8 points on the ISI) and 38% met criteria for remission (ISI < 8). Evaluation of diary entries showed large improvement in sleep continuity and quality over time (ds = 0.68–1.07). Discussion: Consistent with controlled studies, our real-world data suggests that digital CBT-I can yield clinically meaningful improvements in sleep and insomnia severity. The results support the implementation of digital therapeutics within primary care.