EveningnessNCT07677930
Digital Insomnia and Circadian Therapy for Reducing Depression Symptoms in College Students
A study testing digital cognitive behavioral therapy for insomnia and digital circadian intervention, digital cognitive behavioral therapy for insomnia and digital health education in people with Eveningness and Insomnia, run by Chinese University of Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Eveningness, Insomnia, Circadian Rhythm
- What is being tested?
- digital cognitive behavioral therapy for insomnia and digital circadian intervention, digital cognitive behavioral therapy for insomnia and digital health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Eveningness, Insomnia, Circadian Rhythm, Depressed Mood
- Being tested
- digital cognitive behavioral therapy for insomnia and digital circadian intervention, digital cognitive behavioral therapy for insomnia, digital health education
- Keywords
- Eveningness, Insomnia, Depressed Mood, Circadian Rhythm
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital cognitive behavioral therapy for insomnia and digital circadian interventionBehavioural
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 cognitive behavioral therapy for insomniaBehavioural
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.
digital health educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| dCBT-I + dCI group | Experimental | Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia and digital circadian intervention. Receives: Behavioral: digital cognitive behavioral therapy for insomnia and digital circadian intervention |
| dCBT-I group | Active comparator | Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia. Receives: Behavioral: digital cognitive behavioral therapy for insomnia |
| d-HE group | Active comparator | Potential subjects will receive digital health education. Receives: Other: digital health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EveningnessStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN NGAN YIN, Chinese University of Hong Kong
- Investigators
- Ngan Yin Chan, PhD, Principal investigator, Department of Psychiatry, the Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677930
- Sponsor's protocol ID
- 2024.692
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevent Worsening of Depressive Symptoms Using Digital Cognitive Behavioral Therapy for Insomnia and Circadian Intervention in College Students
- ClinicalTrials.gov ID
- NCT07677930
- Acronym / sponsor ID
- 2024.692
- Conditions
- Eveningness, Insomnia, Circadian Rhythm, Depressed Mood
- Keywords
- Eveningness, Insomnia, Depressed Mood, Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dCBT-I + dCI group | Experimental | Behavioral: digital cognitive behavioral therapy for insomnia and digital circadian interventionPotential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia and digital circadian intervention. |
| dCBT-I group | Active comparator | Behavioral: digital cognitive behavioral therapy for insomniaPotential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia. |
| d-HE group | Active comparator | Other: digital health educationPotential subjects will receive digital health education. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital cognitive behavioral therapy for insomnia and digital circadian interventionFor 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 | Behavioural | dCBT-I + dCI group |
| digital cognitive behavioral therapy for insomniaDigital 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. | Behavioural | dCBT-I group |
| digital health educationParticipants 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. | Other | d-HE group |
Primary outcome
Change in clinician-rated depressive symptom severity measured by the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Time frame: 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.
17 secondary outcomes
Change in self-reported depressive symptom severity measured by the 9-item Patient Health Questionnaire (PHQ-9)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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)
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
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
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
Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Eveningness
Not yet recruiting
Efficacy of Cognitive Behavioural Therapy for Insomnia and Bright Light Therapy in Adolescents With ADHD, Insomnia, and Evening Chronotype
Insomnia, ADHD
Recruiting
Chronotype Alignment and Time Perception
Chronotype, Circadian Rhythm
Recruiting
Effect of Bright Light Therapy on Idiopathic Scoliosis
Idiopathic Scoliosis, Eveningness
Recruiting
Adjunctive Bright Light Therapy in Adolescents With Depression and Eveningness
Depression, Unipolar
Active, not recruiting
Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness
Bipolar Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ngan Yin Chan, PhD principal investigator
Department of Psychiatry, the Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing digital cognitive behavioral therapy for insomnia and digital circadian intervention, digital cognitive behavioral therapy for insomnia and digital health education in people with Eveningness and Insomnia, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ngan Yin CHAN, PhD (39710548, rachel.chan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinician-rated depressive symptom severity measured by the 17-item Hamilton Rating Scale for Depression (HRSD-17) (time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.