Real-world evidence for the use of digital cognitive behavioural therapy for insomnia within primary care

Abstract Background The introduction of digital health applications (DiGAs) in the German healthcare system has enabled scalable access to guideline-recommended treatment for chronic insomnia. Since October 2020, the DiGA somnio has been available for prescription by practitioners offering digital cognitive behavioural therapy for insomnia (CBT-I) for patients with an insomnia diagnosis. The availability of user data now allows us to investigate the effects of digital CBT‑I as part of standard care for the first time. Objective An 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) score ≥ 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 was 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 the start and the end of the programme (d = 1.58). At completion, 57% met the response criteria (reduction ≥ 8 points on the ISI) and 38% met the criteria for remission (ISI < 8). Evaluation of diary entries showed a large improvement in sleep continuity and quality over time (ds = 0.68–1.07). Conclusion Consistent with controlled studies, our real-world data suggest that digital CBT-I can yield clinically meaningful improvements in sleep and the ISI. The results support implementation of digital therapeutics within primary care.