The Application Value of Cognitive Behavioral Therapy for Insomnia Software in the Adjunctive Treatment of Patients with Sleep Disorders: A Randomized Controlled Trial

Dongya Zhao

GBP Proceedings Series, 2025, vol. 13, 1-6

Abstract: Background: Insomnia is a prevalent sleep disorder with considerable implications for public health. Cognitive behavioral therapy for insomnia (CBTI) is regarded as the first-line treatment, yet its dissemination remains restricted. Digital CBTI solutions may offer a practical and scalable alternative. Objective: To assess the therapeutic effectiveness and usability of a CBTI program (XDK-CBTI-01) in individuals with primary insomnia. Methods: From January to December 2024, a single-center randomized controlled trial was performed. A total of 130 participants with primary insomnia were randomly allocated to either the experimental group (CBTI software plus sleep hygiene education, n = 65) or the control group (sleep hygiene education only, n = 65). The intervention period was 8 weeks. The primary endpoint was the Insomnia Severity Index (ISI); secondary endpoints included the Pittsburgh Sleep Quality Index (PSQI), Generalized Anxiety Disorder-7 (GAD-7), and Patient Health Questionnaire-9 (PHQ-9). Measurements were obtained at baseline and at the 8-week mark. Results: Compared with controls, the experimental group exhibited significantly greater decreases in ISI (16.28 ± 3.24 to 8.41 ± 2.09 vs. 16.09 ± 3.31 to 12.38 ± 2.47, P < 0.001) and PSQI (13.81 ± 2.13 to 7.09 ± 1.92 vs. 13.74 ± 2.09 to 10.34 ± 2.11, P < 0.001). No meaningful group differences emerged for GAD-7 or PHQ-9 (P > 0.05). Conclusions: The CBTI program markedly alleviated insomnia severity and enhanced subjective sleep quality in primary insomnia patients, though its influence on anxiety and depression was limited. Digital CBTI demonstrates strong feasibility.

Keywords: cognitive behavioral therapy for insomnia; digital health; randomized controlled trial; sleep disorder (search for similar items in EconPapers)
Date: 2025
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