Digital Insomnia and Circadian Therapy for Reducing Depression Symptoms in College Students
2026年8月31日 更新者：CHAN NGAN YIN、Chinese University of Hong Kong
Prevent Worsening of Depressive Symptoms Using Digital Cognitive Behavioral Therapy for Insomnia and Circadian Intervention in College Students
Depression is a leading cause of global disease burden, poor quality of life, disability and suicide, and commonly occurs in adolescence and early adulthood.
Insomnia and circadian factors were regarded as potential targets for preventing worsening of depressive symptoms.
Additionally, digital insomnia treatment reduces depressive symptoms but is insufficient for individuals with an evening chronotype.
Circadian intervention is an adjunctive treatment for sleep disturbance and depression, but is often overlooked.
In this study, we aim to evaluate the effect of guided digital insomnia and circadian intervention (dCBT-I + dCI) in reducing depressive symptoms in college students with insomnia and an evening chronotype compared with digital insomnia intervention alone (dCBT-I) and a health education group (dHE).
We also aim to develop and evaluate multimodal prediction models to identify individuals who are more or less likely to respond to the interventions, using clinical, behavioral, circadian, and digital engagement data.
研究概览
地位
尚未招聘
详细说明
The current study is a three-arm randomized controlled trial.
Guided by a trained sleep therapist, all participants will receive 6-week education content delivered via a mobile application and 6 brief phone call follow-ups.
They will be re-assessed at post intervention, and 6-month after intervention to evaluate the efficacy and sustainability of the therapist-guided digital insomnia and circadian intervention.
研究类型
介入性
注册 (估计的)
195
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ngan Yin CHAN, PhD
- 电话号码：39710548
- 邮箱：rachel.chan@cuhk.edu.hk
研究联系人备份
- 姓名：Yong Wei
- 电话号码：39710548
- 邮箱：elaineyongwei@link.cuhk.edu.hk
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Youths aged between 18-24 years old.
- Insomnia disorders as determined by DSM-5 criteria with a predominant complaint of difficulty initiating sleep.
- Presence of an evening chronotype according to the score on the Horne-Östberg Morning-Eveningness Questionnaire (MEQ) and having a late bedtime of 12:00 am/midnight or later for at least 3 nights per week in the last 3 months.
- Presented with at least subclinical depressive symptoms as determined by Patient Health Questionnaire-9 ≥ 10.
- Accessibility to a smartphone.
Exclusion Criteria:
- Having a diagnosed sleep disorder that may potentially contribute to the disruption of sleep quantity and quality other than insomnia and delayed sleep phase syndrome, as ascertained by Structured Diagnostic Interview for Sleep patterns and Disorders (DISP), such as restless leg syndrome and OSA, and narcolepsy.
- Diagnosed with neuropsychiatric disorders such as major depressive disorder, anxiety disorders, bipolar affective disorders, schizophrenia, moderate or above suicidality.
- Concurrent, regular use of medications known to affect sleep continuity and quality, including both Western medications (e.g. hypnotics, steroids, antidepressants, antihistamines) and over-the-counter medications (e.g. melatonin).
- Participate in other psychotherapy (e.g., CBT, mindfulness) currently or in the past three months.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：dCBT-I + dCI group
Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia and digital circadian intervention.
|
For the combined dCBT-I + dCI program, additional circadian intervention will be included to support entrainment of the biological clock. These components include circadian education, strategies to gradually advance circadian phase, advice on morning sunlight exposure, and components of social rhythm therapy to establish a consistent daily sleep routine (e.g., consistent meal times and exercise). The digital intervention will be implemented through a therapist-guided using motivational interviewing approach. Participants will be motivated to advance their sleep schedule by following fixed daytime activities using motivational interviewing techniques to support their autonomy and self-efficacy in making behavioral changes |
|
有源比较器：dCBT-I group
Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia.
|
Digital CBT-I has been developed by our group based on a well-established framework that includes sleep education, behavioral strategies such as stimulus control and sleep restriction, constructive worry strategies, cognitive restructuring, relaxation training and sleep hygiene education.
For the dCBT-I alone group, therapists will primarily review participants' sleep schedule, setting sleep restriction window, and problem-solving efforts.
|
|
有源比较器：d-HE group
Potential subjects will receive digital health education.
|
Participants in the control group will be app-based general health education with an equivalent dosage as the two intervention groups.
To control for therapist contact time, the health education control group will also receive brief telephone follow-up sessions that focus solely on reviewing the content of the educational modules, without incorporating any active sleep-related intervention strategies.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in clinician-rated depressive symptom severity measured by the 17-item Hamilton Rating Scale for Depression (HRSD-17)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
The 17-item Hamilton Rating Scale for Depression (HRSD-17) is a clinician-administered rating scale used to assess the severity of depressive symptoms.
Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity and a worse outcome.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes of healthcare utility and disease impairment between baseline and follow ups
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
measure the healthcare cost related to disease and the associated impairment
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in self-reported depressive symptom severity measured by the 9-item Patient Health Questionnaire (PHQ-9)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
The 9-item Patient Health Questionnaire (PHQ-9) is a self-report questionnaire used to assess the severity of depressive symptoms.
Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity and a worse outcome.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in depressive symptom severity measured by the Hospital Anxiety and Depression Scale depression subscale (HADS-D)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
Depressive symptom severity will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D).
Total scores range from 0 to 21, with higher scores indicating greater depressive symptom severity and a worse outcome.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in anxiety symptom severity measured by the Hospital Anxiety and Depression Scale anxiety subscale (HADS-A)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
Anxiety symptom severity will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A).
Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity and a worse outcome.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Incidence of Major Depressive Disorder (MDD) assessed using the Structured Clinical Interview for DSM-5 Disorders (SCID-5)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
Major depressive disorder (MDD) will be assessed using the clinician-administered Structured Clinical Interview for DSM-5 Disorders (SCID-5).
The outcome will indicate whether the participant meets DSM-5 diagnostic criteria for MDD at each assessment time point.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in resilience measured by the 10-item Connor-Davidson Resilience Scale (CD-RISC-10)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
The 10-item Connor-Davidson Resilience Scale (CD-RISC-10) is a self-report questionnaire used to assess resilience.
Each of the 10 items is rated from 0 to 4 and summed to produce a total score ranging from 0 to 40.
Higher scores indicate greater resilience and a better outcome.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in insomnia symptom severity measured by the Insomnia Severity Index (ISI)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
The Insomnia Severity Index (ISI) is a self-report questionnaire used to assess the severity of insomnia symptoms.
Total scores range from 0 to 28, with higher scores indicating greater insomnia symptom severity and a worse outcome.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in chronotype measured by the Munich Chronotype Questionnaire (MCTQ) and Morningness-Eveningness Questionnaire (MEQ)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
The MCTQ assesses individual sleep-wake timing and chronotype based on habitual sleep patterns on workdays and free days, while the MEQ is a self-report questionnaire used to assess morningness-eveningness preference.
Higher MEQ scores indicate greater morning preference.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in biological rhythm disturbance measured by the Traditional Chinese Self-Report Version of the Biological Rhythms Interview of Assessment in Neuropsychiatry (C-BRIAN-SR)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
The Traditional Chinese Self-Report Version of the Biological Rhythms Interview of Assessment in Neuropsychiatry (C-BRIAN-SR) is a self-report questionnaire used to assess disturbances in biological rhythms across domains such as sleep, activity, social rhythms, and eating patterns.
Total scores range from 18 to 72, with higher scores indicating greater socio-biological rhythm disturbance.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
The Pittsburgh Sleep Quality Index (PSQI) is a validated 19-item self-report questionnaire that assesses sleep quality and sleep disturbances over the previous month.
Higher global scores indicate poorer sleep quality.
A PSQI global score greater than 5 is generally indicative of poor sleep quality.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in daytime sleepiness measured by the Epworth Sleepiness Scale (ESS)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
The Epworth Sleepiness Scale (ESS) is an 8-item self-report questionnaire used to assess the level of daytime sleepiness by evaluating the likelihood of falling asleep in various everyday situations.
Higher total scores indicate greater daytime sleepiness.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in health-related quality of life measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) is a standardized self-report instrument that assesses health status across five dimensions.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in smartphone-based multimodal behavioral and mood measures assessed using an ecological momentary assessment (EMA) smartphone application
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
Data will be collected using a modified smartphone-based ecological momentary assessment (EMA) application, which captures assessments twice daily.
The app records facial expression features (including the omega sign), voice characteristics, language use patterns, subjective mood, and subjective energy level to provide a multidimensional assessment of behavioral and emotional functioning.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in stressful life events and perceived stress measured by the Life Experiences Survey (LES)
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
The Life Experiences Survey (LES) is a self-report questionnaire used to assess major life events experienced by an individual and the subjective stress associated with those events.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in physical activity level and timing measured by the Physical Activity Rating for Children and Youth and wearable activity monitoring
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
Physical activity will be assessed using the Physical Activity Rating for Children and Youth (PARCY) and a wearable activity monitor.
These measures will be used to quantify the level, timing, duration, and intensity of physical activity, which are important factors in circadian regulation.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in sleep-wake patterns measured by 7-day actigraphy and app-based sleep diaries
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
Sleep-wake patterns will be assessed using prospective 7-day actigraphy (ActiGraph) and app-based sleep diaries, including sleep duration, bedtime, wake-up time, sleep efficiency, and sleep onset latency.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in circadian rhythm measured by 7-day actigraphy and app-based sleep diaries
大体时间：baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
Circadian rhythm will be assessed using prospective 7-day actigraphy (ActiGraph) and app-based sleep diaries.This will be evaluated through continuous monitoring of rest-activity rhythms, sleep-wake cycles, and physical activity captured by ActiGraph, with circadian metrics derived using nonparametric circadian rhythm analysis.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ngan Yin Chan, PhD、Department of Psychiatry, The Chinese University of Hong Kong
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2029年6月30日
研究完成 (估计的)
2029年6月30日
研究注册日期
首次提交
2026年6月19日
首先提交符合 QC 标准的
2026年6月29日
首次发布 (实际的)
2026年7月1日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年8月31日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.