Digital Insomnia and Circadian Therapy for Reducing Depression Symptoms in College Students
29 giugno 2026 aggiornato da: CHAN NGAN YIN, Chinese University of Hong Kong
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
195
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Ngan Yin CHAN, PhD
- Numero di telefono: 39710548
- Email: rachel.chan@cuhk.edu.hk
Backup dei contatti dello studio
- Nome: Yong Wei
- Numero di telefono: 39710548
- Email: elaineyongwei@link.cuhk.edu.hk
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: dCBT-I + dCI group
Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia and digital circadian intervention.
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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 |
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Comparatore attivo: dCBT-I group
Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia.
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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.
|
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Comparatore attivo: d-HE group
Potential subjects will receive digital health education.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes of Hamilton Rating Scale for Depression (HRSD) between baseline and follow ups
Lasso di tempo: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
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A 17-item clinician-administered instrument to assess depressive symptomatology.
It will be rated by an independent assessor blinded to the randomization status.
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes of Patient Health Questionnaire 9-item (PHQ-9) between baseline and follow ups
Lasso di tempo: 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
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Changes of Hospital Anxiety and Depression Scale (HADS) between baseline and follow ups
Lasso di tempo: 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
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Changes of Incidence of major depression disorders at follow ups
Lasso di tempo: 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).
|
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
Lasso di tempo: 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.
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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
Lasso di tempo: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
ISI is used to measure the severity of insomnia symptoms
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Changes of 7-day actigraphy and app-based sleep diary outcomes between baseline and follow ups
Lasso di tempo: 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.
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Changes of Munich chronotype questionnaire (MCTQ) and morningness-eveningness questionnaire (MEQ) between baseline and follow ups
Lasso di tempo: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
MCTQ and MEQ are used to measure chronotype.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Changes of The Traditional Chinese self-report version of Biological Rhythms Interview for Assessment in Neuropsychiatry between baseline and follow ups
Lasso di tempo: 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
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Changes of Pittsburgh Sleep Quality Index (PSQI) between baseline and follow ups
Lasso di tempo: 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
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Changes of The Epworth Sleepiness Scale (ESS) between baseline and follow ups
Lasso di tempo: 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
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Changes of EuroQol 5-Dimension 5-Level Questionnaire between baseline and follow ups
Lasso di tempo: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Changes of Smartphone-based multimodal measurement between baseline and follow ups
Lasso di tempo: 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
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Changes of healthcare utility and disease impairment between baseline and follow ups
Lasso di tempo: 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
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Changes of stressful life events between baseline and follow ups
Lasso di tempo: 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.
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
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Changes in the level and timing of physical activity between baseline and follow ups
Lasso di tempo: 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.
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Ngan Yin Chan, PhD, Department of Psychiatry, the Chinese University of Hong Kong
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 luglio 2026
Completamento primario (Stimato)
30 giugno 2029
Completamento dello studio (Stimato)
30 giugno 2029
Date di iscrizione allo studio
Primo inviato
19 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 giugno 2026
Primo Inserito (Effettivo)
1 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Disordini mentali
- Manifestazioni neurocomportamentali
- Disturbi neurocognitivi
- Disturbi del sonno e della veglia
- Disturbi del sonno, intrinseci
- Dissonnie
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Disturbi dell'inizio e del mantenimento del sonno
- Disturbi della coscienza
Altri numeri di identificazione dello studio
- 2024.692
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .