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失眠认知行为疗法(Smart CBT-I-CBTI plus)在线项目在失眠障碍合并焦虑和抑郁患者中的适用性和有效性:一项前瞻性随机对照试验方案

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

Frontiers in Oncology 等信源发布 2025-02-07 08:02

可切换为仅中文


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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.

背景:失眠常伴有抑郁和焦虑,严重影响人们的生活质量。失眠认知行为疗法(CBT-I)是一线治疗方法,但现有的CBT-I忽视了对焦虑抑郁症状的干预,由于缺乏人工支持、依从性差、无法广泛传播和下降率高,疗效不佳。

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.

需要在基于网络的技术的便利性和效率与患者需求之间取得平衡。同样在这种情况下,将以CBT-I技术为核心开发在线微信小程序(Smart CBT-I plus),整合抑郁症和焦虑症的认知行为干预模块。目标:本研究将通过检查Smart CBT-I plus研究组与心理教育组相比,是否会显着减轻患有焦虑和/或抑郁症状的失眠患者的痛苦,来验证Smart CBT-I plus的有效性和适用性。

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).

方法:在这项平行组随机对照试验中,将招募180名因失眠伴焦虑和/或抑郁寻求帮助的患者,并将其随机分为60名患者被分配到心理教育组(对照组),120名患者被分配到Smart CBT-I plus组(研究组)。

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.

将在基线,干预后,6个月和12个月的随访中进行测量,同时,将对研究组中随机选择的患者进行关于使用Smart CBT-I plus的经验的半结构化定性访谈。结果:结果将涉及失眠、抑郁和焦虑,探讨其有效性,在治疗辍学率和患者主观反馈方面的适用性。