Digital Insomnia and Circadian Therapy for Reducing Depression Symptoms in College Students
31. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
195
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Ngan Yin CHAN, PhD
- Telefonní číslo: 39710548
- E-mail: rachel.chan@cuhk.edu.hk
Studijní záloha kontaktů
- Jméno: Yong Wei
- Telefonní číslo: 39710548
- E-mail: elaineyongwei@link.cuhk.edu.hk
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in clinician-rated depressive symptom severity measured by the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Časové okno: 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.
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes of healthcare utility and disease impairment between baseline and follow ups
Časové okno: 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
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Change in self-reported depressive symptom severity measured by the 9-item Patient Health Questionnaire (PHQ-9)
Časové okno: 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.
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Change in depressive symptom severity measured by the Hospital Anxiety and Depression Scale depression subscale (HADS-D)
Časové okno: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in anxiety symptom severity measured by the Hospital Anxiety and Depression Scale anxiety subscale (HADS-A)
Časové okno: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Incidence of Major Depressive Disorder (MDD) assessed using the Structured Clinical Interview for DSM-5 Disorders (SCID-5)
Časové okno: 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.
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Change in resilience measured by the 10-item Connor-Davidson Resilience Scale (CD-RISC-10)
Časové okno: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Change in insomnia symptom severity measured by the Insomnia Severity Index (ISI)
Časové okno: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in chronotype measured by the Munich Chronotype Questionnaire (MCTQ) and Morningness-Eveningness Questionnaire (MEQ)
Časové okno: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
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)
Časové okno: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
Časové okno: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in daytime sleepiness measured by the Epworth Sleepiness Scale (ESS)
Časové okno: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Change in health-related quality of life measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Časové okno: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Change in smartphone-based multimodal behavioral and mood measures assessed using an ecological momentary assessment (EMA) smartphone application
Časové okno: 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.
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Change in stressful life events and perceived stress measured by the Life Experiences Survey (LES)
Časové okno: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in physical activity level and timing measured by the Physical Activity Rating for Children and Youth and wearable activity monitoring
Časové okno: 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.
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
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Change in sleep-wake patterns measured by 7-day actigraphy and app-based sleep diaries
Časové okno: 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.
|
baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
|
|
Change in circadian rhythm measured by 7-day actigraphy and app-based sleep diaries
Časové okno: 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.
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baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Ngan Yin Chan, PhD, Department of Psychiatry, The Chinese University of Hong Kong
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. září 2026
Primární dokončení (Odhadovaný)
30. června 2029
Dokončení studie (Odhadovaný)
30. června 2029
Termíny zápisu do studia
První předloženo
19. června 2026
První předloženo, které splnilo kritéria kontroly kvality
29. června 2026
První zveřejněno (Aktuální)
1. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
3. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
31. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
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