Digital Insomnia and Circadian Therapy for Reducing Depression Symptoms in College Students

NCT07677930 | Not Yet Recruiting

• 1 other identifier: 2024.692
• Study Type: interventional
• Target: 195
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Eveningness; Insomnia; Circadian Rhythm; Depressed Mood

Keywords

Eveningness; Insomnia; Depressed Mood; Circadian Rhythm

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (15)

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

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

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

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

• Changes of Incidence of major depression disorders at follow ups

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

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

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

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

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

Study Arms (3)

dCBT-I + dCI group

EXPERIMENTAL

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

dCBT-I group

ACTIVE COMPARATOR

Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia.

Behavioral: digital cognitive behavioral therapy for insomnia

d-HE group

ACTIVE COMPARATOR

Potential subjects will receive digital health education.

Other: digital health education

Interventions

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.

dCBT-I group

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.

d-HE group

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

dCBT-I + dCI group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Consciousness Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Study Officials

• Ngan Yin Chan, PhD

  Department of Psychiatry, the Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ngan Yin CHAN, PhD

CONTACT

39710548; rachel.chan@cuhk.edu.hk

Yong Wei

CONTACT

39710548; elaineyongwei@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share