Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07677930

Digital Insomnia and Circadian Therapy for Reducing Depression Symptoms 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Eveningness Circadian Rhythm Consciousness Disorders Depressed Mood Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

digital cognitive behavioral therapy for insomnia and digital circadian intervention

Behavioral

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 insomnia

Behavioral

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 education

Other

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.

Primary outcomes

  1. Changes of Hamilton Rating Scale for Depression (HRSD) between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    A 17-item clinician-administered instrument to assess depressive symptomatology. It will be rated by an independent assessor blinded to the randomization status.

Secondary outcomes

  1. Changes of Patient Health Questionnaire 9-item (PHQ-9) between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    PHQ-9 is used to measure the severity of depressive symptoms

  2. Changes of Hospital Anxiety and Depression Scale (HADS) between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    HADS is used to measure self-reported depression and anxiety severity

  3. Changes of Incidence of major depression disorders at follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    The incidence of major depression disorder will be assessed through structured clinical interview according to DSM-V criteria (SCID-5).

  4. Changes of The Connor-Davidson Resilience Scale - 10 item (CDRS-10) between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    CDRS-10 is used to measure different components of resilience. This 10-item instrument uses a 5-point scale (0 = "Not true at all" to 4 = "True nearly all the time"), where higher scores denote greater resilience.

  5. Changes of Insomnia Severity Index (ISI) between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    ISI is used to measure the severity of insomnia symptoms

  6. Changes of 7-day actigraphy and app-based sleep diary outcomes between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    Prospective 7-day actigraphy and app-based sleep diaries are used to record sleep-wake patterns, including sleep duration, wake-up time, bedtime, sleep efficiency and sleep onset latency. Circadian rhythm will also be assessed through continuous monitoring of rest-activity rhythm, sleep-wake cycles, and physical activity captured by ActiGraph using nonparametric circadian rhythm analysis.

  7. Changes of Munich chronotype questionnaire (MCTQ) and morningness-eveningness questionnaire (MEQ) between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    MCTQ and MEQ are used to measure chronotype.

  8. Changes of The Traditional Chinese self-report version of Biological Rhythms Interview for Assessment in Neuropsychiatry between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    The C-BRIAN-SR scale demonstrated a high level of internal consistency in all 160 subjects, with a Cronbach's alpha value of 0.92 for the 18 items (Table 3), and a value of 0.91 for the 21 items. The total BRIAN scores range from 18 to 72, where the higher value indicates higher socio-biological rhythm disturbance

  9. Changes of Pittsburgh Sleep Quality Index (PSQI) between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    The PSQI is a validated 19-item self-report questionnaire that evaluates sleep quality and disturbances in the past month. Higher total scores indicate poorer sleep quality. A global score greater than 5 is generally indicative of poor sleep quality

  10. Changes of The Epworth Sleepiness Scale (ESS) between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    8-item ESS will be used to assess youths' daytime sleepiness

  11. Changes of EuroQol 5-Dimension 5-Level Questionnaire between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    EQ-5D-5L covers five dimensions of health and has recently been validated locally in youth.

  12. Changes of Smartphone-based multimodal measurement between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    Multimodal assessments will be captured through our modified smartphone app. The app is equipped with EMA monitoring of facial expression recording (including omega sign), voice, language use, and subjective mood and energy level for 2 times per day

  13. 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

    measure the healthcare cost related to disease and the associated impairment

  14. Changes of stressful life events between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    Life Experience Survey (LES) will be included to measure major life events and self-perceived stress associated with these events that an individual has experienced.

  15. Changes in the level and timing of physical activity between baseline and follow ups

    Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up

    The level and timing of physical activity are important factors for circadian regulation, it would be captured by the physical activity rating for children and youth, as well as the wearable, which could quantify the duration and intensity of physical activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Ngan Yin CHAN, PhD

CONTACT

[email protected]

39710548

Yong Wei

CONTACT

[email protected]

39710548

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Prevent Worsening of Depressive Symptoms Using Digital Cognitive Behavioral Therapy for Insomnia and Circadian Intervention in College Students

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.