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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.

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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. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

  8. 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

    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.

  9. 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

    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.

  10. 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

    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.

  11. 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

    The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) is a standardized self-report instrument that assesses health status across five dimensions.

  12. 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

    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.

  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. 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

    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.

  15. 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

    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.

  16. 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

    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.

  17. 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

    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.

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
Sep 3, 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.

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