がん患者の疼痛におけるデジタル認知行動療法（DCBT-I）：前向き無作為化比較試験のプロトコル

Xiaoxiao Lan¹, Xin Hu¹, Zhixuan Lan¹

¹Department of Pain Medicine, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530007, People's Republic of China.

Journal of pain research

|December 30, 2025

要旨

Introduction:

Insomnia is one of the most common complications in cancer patients, and Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for insomnia in the general population and patients with a cancer diagnosis. Traditional CBT-I is susceptible to limitations such as geography, physical condition, and cost of access to healthcare, hindering its widespread adoption. With the application and development of digitalization and artificial intelligence providing opportunities for the administration and promotion of Digital Cognitive Behavioral Therapy for Insomnia (DCBT-I) to provide a better sleep treatment option for cancer pain patients, this study aims to evaluate its efficacy.

Methods:

This single-center trial will randomize 158 cancer pain patients with insomnia to DCBT-I or sleep hygiene education (1:1) to test if DCBT-I is superior for improving sleep quality. Assessments will also cover pain intensity, mental health, and quality of life.

Discussion:

This study will provide valuable clinical evidence that DCBT-I helps to improve sleep quality, pain intensity, mental health, and quality of life in cancer pain patients suffering from insomnia and contributes to the dissemination of this non-pharmacological alternative treatment option.

Conclusion:

This study protocol outlines a rigorous randomized controlled trial to evaluate the efficacy of Digital Cognitive Behavioral Therapy for Insomnia (DCBT-I) compared to Sleep Hygiene Education (SHE) in cancer pain patients with comorbid insomnia. The Resleep smartphone-based intervention integrates evidence-based CBT-I components (sleep restriction, stimulus control, cognitive restructuring, and relaxation training) to address the limitations of traditional therapy, such as accessibility and cost.

Clinical Trial Registration:

This study is a registered clinical trial.

Registry:

Chinese Clinical Trial Registry (ChiCTR), listed in the WHO International Clinical Trials Registry Platform (WHO ICTRP).

Trial Registration Number:

ChiCTR2500096855.

Date Of Registration:

07 February 2025.

Registration Url:

https://www.chictr.org.cn/index.html.

キーワード:

DCBT-I がん性疼痛不眠症睡眠衛生教育