NCT06593262进行中（未招募）不适用
Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) With Artificial Intelligence Chatbot for Youth With Insomnia: An Assessor-blind, Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
Experimental
干预措施: app-based digital cognitive behavioral therapy for insomnia with AI chatbot (Behavioral)
app-based digital cognitive behavioral therapy for insomnia without AI chatbot
Active Comparator
干预措施: app-based digital cognitive behavioral therapy for insomnia without AI chatbot (Behavioral)
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))
研究者
Tim M. H. Li
Prof.
Chinese University of Hong Kong
研究点 (1)
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