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

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  • Zhao, Dongya

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.

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  • Zhao, Dongya, 2025. "The Application Value of Cognitive Behavioral Therapy for Insomnia Software in the Adjunctive Treatment of Patients with Sleep Disorders: A Randomized Controlled Trial," GBP Proceedings Series, Scientific Open Access Publishing, vol. 13, pages 1-6.
    • Handle: RePEc:axf:gbppsa:v:13:y:2025:i::p:1-6
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