Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) With Artificial Intelligence Chatbot for Youth With Insomnia: An Assessor-blind, Randomized Controlled Trial

Chinese University of Hong Kong1 个研究点分布在 1 个国家目标入组 168 人2024年7月26日

干预措施app-based digital cognitive behavioral therapy for insomnia with AI chatbot app-based digital cognitive behavioral therapy for insomnia without AI chatbot

概览

阶段: 不适用
干预措施: app-based digital cognitive behavioral therapy for insomnia with AI chatbot
疾病 / 适应症: Insomnia
发起方: Chinese University of Hong Kong
入组人数: 168
试验地点: 1
主要终点: Insomnia Severity Index
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

Insomnia is a common sleep problem, which affects 9.4-38.2% of youths worldwide. Youth insomnia is linked to mental health problems, leading to substantial health and economic burden. The project aims to conduct an assessor-blind, randomized controlled trial to evaluate the efficacy of an app-based CBT-I with AI chatbot in reducing insomnia symptoms among youths, compared to an app-based CBT-I without AI chatbot.

注册库

clinicaltrials.gov

开始日期

2024年7月26日

结束日期

2026年8月1日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Chinese University of Hong Kong

责任方

Principal Investigator

主要研究者

Tim M. H. Li

Prof.

Chinese University of Hong Kong

入排标准

入选标准

•i. Youth aged 18 to 25 years (as defined by WHO and evidence on AI mental health chatbots only available for individuals aged 18 years and older)
•ii. Online informed consent of participation in the study should be provided
•iii. Willing to comply with the requirements of the study protocol
•iv. The presence of moderate to severe insomnia measured by a score of 15 or above on the Insomnia Severity Index (ISI)
•v. difficulties initiating, maintaining or nonrestorative sleep over a 1-month period
•vi. Having access to a smartphone and consistent internet access for their smartphone
•vii. Accepting the terms of service and privacy policies of the mobile apps used in the study for the delivery of the intervention

排除标准

•i. A history of any sleep disorder(s) (other than insomnia disorder) such as narcolepsy, obstructive sleep apnea, and restless legs syndrome
•ii. A history of any mental retardation or neuropsychiatric disorder(s) (other than depression and anxiety disorders as they are the secondary outcomes) such as bipolar disorder, schizophrenia, and substance use disorder
•iii. Presence of serious suicidality as evidenced by ideation with a plan or an attempt
•iv. Receiving any pharmacological treatment (including sleep promoting agents)
•v. Receiving any structured psychotherapy
•vi. Having shiftwork and trans-meridian travel in the past 3 months and during the intervention

研究组 & 干预措施

app-based digital cognitive behavioral therapy for insomnia with AI chatbot

干预措施: app-based digital cognitive behavioral therapy for insomnia with AI chatbot

app-based digital cognitive behavioral therapy for insomnia without AI chatbot

干预措施: app-based digital cognitive behavioral therapy for insomnia without AI chatbot

结局指标

主要结局

Insomnia Severity Index

时间窗: a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)

the severity of insomnia symptoms

次要结局

sleep onset latency (SOL)(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
wake after sleep onset (WASO)(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
sleep efficiency (SE)(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
Total sleep time (TST)(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
The Pre-Sleep Arousal Scale(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
The Cognitive Failures Questionnaire(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
Ford Insomnia Response to Stress Test(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
reduced Horne and Östberg Morningness and Eveningness Questionnaire(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
The Dysfunctional Beliefs and Attitudes about Sleep Scale(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
Patient Health Questionnaire-9(a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
General Anxiety Disorder-7(a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
The Sleep Hygiene Index(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
The Charlotte Attitudes Towards Sleep Scale(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))
The Multidimensional Fatigue Inventory(a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline))