| Summary: | Abstract Background Digital cognitive behavior therapy for insomnia (dCBT-I) is an effective treatment in alleviating insomnia. This study examined the effect of dCBT-I for improving sleep quality in patients with insomnia complaints from a clinical population in a real-world setting. Methods The study included 6,002 patients aged 18 years and above with primary complaints of dissatisfying sleep from a sleep clinic in a psychiatric hospital from November 2016 to April 2021. Patients were diagnosed with insomnia, anxiety disorders, or anxiety comorbid with insomnia or depression according to ICD-10. A mobile app was developed for self-reported assessment and delivering dCBT-I interventions and treatment prescriptions to participants. The primary outcome was change in global sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). At 8- and 12-week follow-up, 509 patients were reassessed. Data were analyzed with non-parametric tests for repeated measures. Results Patients treated with dCBT-I monotherapy were younger, with a more frequent family history of insomnia compared to those with medication monotherapy and those with combined dCBT-I and medication therapy. Improvements of sleep quality from baseline to 8-week follow-up were significant in each treatment type. Compared to 8-week follow-up, PSQI scores at 12-week were significantly decreased in the depression group receiving combined therapy and in the anxiety group treated with dCBT-I monotherapy and with combined therapy. A time-by-treatment interaction was detected in anxiety patients indicating differential reduction in PSQI scores over time between different treatment options. Conclusion The current findings suggest dCBT-I is a practical and effective approach for lessening insomnia symptoms, especially for patients with anxiety symptoms suggesting with a more extended intervention period (i.e., 12 weeks). Trial registration Chinese Clinical Trial Registry (ChiCTR1900022699).
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