The applicability and effectiveness of the Cognitive Behavioral Therapy for Insomnia (Smart CBT-I-CBTI plus) online program in patients with insomnia disorder combined with anxiety and depression: Aa prospective randomized controlled trial protocol

Yating Zhao ^1,2 Chengmei Yuan ^2* Fangmei Ge ² Xin Luo ² Jingru Li ² Jing Zhang ² Yi Ju ² Jie Zhang ² Yong Wang ² Dongbin Lv ² Yiren Qiu ²

• ¹ Psychiatric Clinic, Shanghai Mental Health Center, Shanghai, China
• ² Shanghai Mental Health Center, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, China

Background：Insomnia is often accompanied by depression and anxiety, which can seriously affect people's quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, but the existing CBT-I ignores the intervention for anxiety-depressive symptoms, and has poor efficacy due to the lack of artificial support, poor compliance, the inability to spread widely and high dropping rate. A balance is needed between the convenience and efficiency of web-based technology and patient needs. Again in this context, an online WeChat applet (Smart CBT-I plus) will be developed with CBT-I technology as the core, integrating cognitive behavioral intervention modules for depression and anxiety.Objectives：This study will validate the effectiveness and applicability of Smart CBT-I plus by examining whether the Smart CBT-I plus study group will significantly reduce the distress of people suffering from insomnia with anxiety and/or depression symptoms compared to the psychoeducational group. Methods: In this parallel-group，randomized controlled trial, 180 patients seeking help for insomnia combined with anxiety and/or depression will be recruited, and they will be randomized with 60 patients being assigned to the psychoeducation group (control group), and 120 patients being assigned to the Smart CBT-I plus group (study group). Measurements will be taken at baseline, post-intervention, 6 and 12 month follow-up，at the same time, semi-structured qualitative interviews about the experience of using Smart CBT-I plus will be conducted with randomly selected patients from the study group.Results: The results will involve insomnia，depression and anxiety to explore its effectiveness, in-treatment dropout rates and subjective patient feedback to explore the applicability of Smart CBT-I plus.Future recommendations：Self-help platforms need to be more individually designed to reach a wider audience. Research aimed at a wider audience, such as the general public, will make the research more universal and the platform more meaningful.