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癌症幸存者失眠的数字化认知行为疗法:一项实用临床试验方案。

Digital Cognitive-Behavioral Therapy for Insomnia in Cancer Survivors: Protocol for a Pragmatic Clinical Trial.

机构信息

Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC). Universidade de Coimbra. Coimbra; Faculty of Psychology and Educational Sciences. Universidade de Coimbra. Coimbra; Chronopsychology and Cognitive Systems Lab (ChronCog). Universidade de Coimbra. Coimbra. Portugal.

Department of Clinical, Neuro and Developmental Psychology & Amsterdam Public Health Research Institute. Vrije Universiteit Amsterdam. Amsterdam. Portugal.

出版信息

Acta Med Port. 2024 Oct 1;37(10):713-719. doi: 10.20344/amp.21094. Epub 2024 Aug 12.

DOI:10.20344/amp.21094
PMID:39140169
Abstract

INTRODUCTION

Insomnia is one of the most prevalent, persistent, and distressing conditions associated with cancer, affecting almost half of all cancer survivors. Although cognitive-behavioral therapy for insomnia is well established as the gold-standard treatment for insomnia, its accessibility is very limited in routine care. We aim to examine the real-world effectiveness and acceptability of a digital cognitive-behavioral therapy for insomnia for cancer survivors with insomnia symptoms through a randomized controlled trial in Portugal.

METHODS AND ANALYSIS

Our cancer trial will test the effects and acceptability of an accessible internet-delivered self-administered cognitive-behavioral therapy for insomnia digital intervention with clinician support, OncoSleep. This online program includes six interactive, personalized weekly sessions featuring evidence-based techniques targeting psychophysiological hyperarousal and maladaptive conditioning, tailored for cancer survivors. Research study procedures include screening for eligibility in the general population and randomization into one of two arms: the digital CBT-I program or a waitlist control group. Insomnia severity (primary outcome), fatigue, sleep diary outcomes, psychological distress, and quality of life (secondary outcomes) will be assessed at baseline and post-intervention.

摘要

简介

失眠是与癌症相关的最普遍、最持久和最痛苦的病症之一,几乎影响了所有癌症幸存者的一半。尽管认知行为疗法被广泛认为是失眠的黄金标准治疗方法,但在常规护理中,其可及性非常有限。我们旨在通过葡萄牙的一项随机对照试验,研究针对有失眠症状的癌症幸存者的数字认知行为疗法治疗失眠的真实世界效果和可接受性。

方法和分析

我们的癌症试验将测试一种易于使用的互联网提供的自我管理认知行为疗法治疗失眠的数字干预措施的效果和可接受性,该干预措施有临床医生的支持,名为 OncoSleep。该在线程序包括六个互动的、个性化的每周课程,针对心理生理过度唤醒和适应不良的条件作用等证据基础技术,为癌症幸存者量身定制。研究程序包括在普通人群中进行筛选,以确定是否符合条件,并随机分为两个组之一:数字 CBT-I 程序或候补对照组。将在基线和干预后评估失眠严重程度(主要结局)、疲劳、睡眠日记结果、心理困扰和生活质量(次要结局)。

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