An interventional study of digital cognitive behavioral therapy for insomnia and digital circadian intervention and digital cognitive behavioral therapy for insomnia in Eveningness, Insomnia and Circadian Rhythm, sponsored by Chinese University of Hong Kong. Not yet recruiting. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Prevention
Among 25 studies in Sleep Initiation and Maintenance Disorders by Chinese University of Hong Kong — 14 open to participants now, 14 under way, none of them phase 3. Sleep Initiation and Maintenance Disorders · Chinese University of Hong Kong.
Among the 25 studies in Sleep Initiation and Maintenance Disorders by Chinese University of Hong Kong, this one is the 6th largest by planned enrollment, is one of 5 that started in 2026, is one of 24 with no phase, reaches primary completion later than 13 of the 13 other live ones, and was the 23rd registered.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 195 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →14 of the 25 studies in Sleep Initiation and Maintenance Disorders by Chinese University of Hong Kong are open now, in 1 country. Each count lists the studies.
Of the 386 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 204 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 18 Years to 24 Years · all sexes · no healthy volunteers.
The full table on the hub →25 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 5 started in 2026.
Median enrollment 80 across the 25 interventional studies. Of the 5 that completed or were terminated, 1 (20%) have results posted.
Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
3 of the studies in Sleep Initiation and Maintenance Disorders by Chinese University of Hong Kong that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07323069Chinese University of Hong KongA Nurse-led Multicomponent Interventional Protocol to Improve Sleep Quality in Paediatric Oncology Patients | 2027-01 |
| NCT06511011Chinese University of Hong KongChinese Medicine in Treating Insomnia | 2027-05 |
| NCT07770516Chinese University of Hong KongCognitive Behavioral Therapy for Insomnia as an Adjunct to Time-restricted Eating on Weight Loss in Adults With Overweight or Obesity and Chronic Insomnia | 2027-06-30 |
Among the 25 studies in Sleep Initiation and Maintenance Disorders by Chinese University of Hong Kong, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia and digital circadian intervention.
Behavioral: digital cognitive behavioral therapy for insomnia and digital circadian intervention
Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia.
Behavioral: digital cognitive behavioral therapy for insomnia
Potential subjects will receive digital health education.
Other: digital health education
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
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.
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.
Change in clinician-rated depressive symptom severity measured by the 17-item Hamilton Rating Scale for Depression (HRSD-17)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) is a standardized self-report instrument that assesses health status across five dimensions.
Time frame: 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
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.
Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
Changes of healthcare utility and disease impairment between baseline and follow ups
measure the healthcare cost related to disease and the associated impairment
Time frame: 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)
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
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Sleep Initiation and Maintenance Disorders →
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