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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dCBT-I + dCI group | Experimental | Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia and digital circadian intervention. |
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| dCBT-I group | Active Comparator | Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia. |
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| d-HE group | Active Comparator | Potential subjects will receive digital health education. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Patient Health Questionnaire 9-item (PHQ-9) between baseline and follow ups | PHQ-9 is used to measure the severity of depressive symptoms | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ngan Yin CHAN, PhD | Contact | 39710548 | rachel.chan@cuhk.edu.hk | |
| Yong Wei | Contact | 39710548 | elaineyongwei@link.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Ngan Yin Chan, PhD | Department of Psychiatry, the Chinese University of Hong Kong | Principal Investigator |
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| 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. |
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| 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. |
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HADS is used to measure self-reported depression and anxiety severity |
| baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up |
| Changes of Incidence of major depression disorders at follow ups | 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 | 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. | 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 | ISI is used to measure the severity of insomnia symptoms | baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up |
| Changes of 7-day actigraphy and app-based sleep diary outcomes between baseline and follow ups | 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. | baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up |
| Changes of Munich chronotype questionnaire (MCTQ) and morningness-eveningness questionnaire (MEQ) between baseline and follow ups | MCTQ and MEQ are used to measure chronotype. | baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up |
| Changes of The Traditional Chinese self-report version of Biological Rhythms Interview for Assessment in Neuropsychiatry between baseline and follow ups | 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 | baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up |
| Changes of Pittsburgh Sleep Quality Index (PSQI) between baseline and follow ups | 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 |
| Changes of The Epworth Sleepiness Scale (ESS) between baseline and follow ups | 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 |
| Changes of EuroQol 5-Dimension 5-Level Questionnaire between baseline and follow ups | 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 |
| Changes of Smartphone-based multimodal measurement between baseline and follow ups | 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 | baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up |
| Changes of healthcare utility and disease impairment between baseline and follow ups | 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 |
| Changes of stressful life events between baseline and follow ups | 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. | baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up |
| Changes in the level and timing of physical activity between baseline and follow ups | 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. | baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
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