digital cognitive behavioral therapy for insomnia and digital circadian interven / digital health education / Circadian Rhythm · Interventional Study

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

ClinicalTrials.gov · September 3, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned three-arm randomized trial comparing combined digital cognitive behavioral therapy for insomnia plus circadian intervention (dCBT-I + dCI) versus dCBT-I alone versus digital health education control in college students with insomnia and evening chronotype. The study aims to measure changes in depressive symptoms by HRSD-17 at baseline, 1-week, and 6-month follow-up, and to develop prediction models for intervention response. No results have been posted to the registry; this document describes the protocol only.

What was studied

Interventional, Randomized, Parallel, Double masking, Prevention purpose. Eveningness, Insomnia, Circadian Rhythm, Depressed Mood; age from 18 Years; to 24 Years. Intervention: dCBT-I + dCI group. Compared with: dCBT-I group — Active Comparator; d-HE group — Active Comparator. n = 195.

Key findings

Safety

This is a registry record with no results posted; no efficacy, safety, or outcome data are available.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record describing a planned interventional study with no results reported; enrollment has not yet begun, making it an early-stage protocol document.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in clinician-rated depressive symptom severity measured by the 17-item Hamilton Rating Scale for Depression (HRSD-17) (assessed at baseline, 1-week post-intervention follow-up, and 6-month post-intervention fol…)

DesignInterventional, Randomized, Parallel, Double masking, Prevention purpose

PopulationEveningness, Insomnia, Circadian Rhythm, Depressed Mood; age from 18 Years; to 24 Years

Sample size195

InterventiondCBT-I + dCI group

ComparatordCBT-I group — Active Comparator; d-HE group — Active Comparator

Reported figures

Quoted from the source exactly as published.

Planned enrollment195

Primary outcome measure17-item Hamilton Rating Scale for Depression (HRSD-17) change from baseline

Follow-up timepoints1-week post-intervention and 6-month post-intervention

Caveats

This is a registry record with no results posted; no efficacy, safety, or outcome data are available.
Recruitment has not yet begun (status: NOT_YET_RECRUITING); study conduct and completion timeline unknown.
Blinding strategy, allocation concealment method, and statistical analysis plan not described in this registry excerpt.
Predictive modelling component described but no specification of model development set, validation approach, or primary prediction outcome.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Three-arm behavioral intervention trial with planned follow-up to 6 months post-intervention.

Directness

strong

Primary outcome directly measures clinician-rated depressive symptom severity using HRSD-17.

Consistency

insufficient

No results reported; consistency cannot be assessed from protocol alone.

Risk of bias

insufficient

Blinding status, allocation concealment, and other trial conduct details not stated in registry record.

Sample adequacy

moderate

Estimated 195 participants across three arms; sample size justification not reported in registry.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07677930). This is a study registration, not published results. Lead sponsor: Chinese University of Hong Kong. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 195 participants (ESTIMATED). Conditions: Eveningness, Insomnia, Circadian Rhythm, Depressed Mood. Interventions: BEHAVIORAL: digital cognitive behavioral therapy for insomnia and digital circadian intervention; BEHAVIORAL: digital cognitive behavioral therapy for insomnia; OTHER: digital health education. Primary outcome measures: Change in clinician-rated depressive symptom severity measured by the 17-item Hamilton Rating Scale for Depression (HRSD-17) , baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

digital cognitive behavioral therapy for insomnia and digital circadian intervenNCT07677930digital health educationChinese University of Hong KongCircadian Rhythmdigital cognitive behavioral therapy for insomniaInsomniaEveningness