An observational study in Major Depressive Disorder (MDD), Sleep Disorders and Circadian Rhythm, sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Chinese University of Hong Kong · Observational
This proposed study will be a longitudinal follow-up study of a case-control study of 160 participants (CREC Ref: 2023.234). This study aims to follow up on the trajectory of depression and rest-activity rhythm (RAR) disruptions, as well as examine their association over time. The investigators aim to identify distinctive RAR profiles of MDD using the data from the original project and hypothesize that two or more groups will be identified based on individual RAR variables using cluster analysis. The investigators hypothesize that significant differences in depressive symptom severity, sleep quality, and other outcome measures collected in this follow-up will be found between the clustered groups. Individuals exhibiting the most disrupted RAR profiles are hypothesized to have the greatest deterioration in depression symptom severity and other outcome measures. The investigators also hypothesize that people persisting with MDD will exhibit greater disruptions in RAR compared to those without MDD at the follow-up. Furthermore, the investigators will examine whether individual RAR parameters are longitudinally associated with changes in depression symptom severity and other outcome measures.
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's planned enrollment of 160 is above the median of 140 across 357 observational studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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The study population will be 160 participants (80 participants with Major Depressive Disorder and 80 age- and gender-matched healthy controls) who participated in a case-control study carried out from 2023 Aug to 2025 Feb in Hong Kong. Those participants will be invited to participate in this study via message, phone call, or email.
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for actigraphy assessment:
This group includes participants who meet the DSM-5 diagnostic criteria for current Major Depressive Disorder based the structured clinical interview SCID-5-RV. In this study, all participants will be given a structured clinical interview SCID-5-RV, complete the baseline assessment and then proceed to 14 days of monitoring of sleep, mood, and activity levels. Objective sleep measurements will be collected through actigraphy (e.g., ActiGraph accelerometer), while subjective sleep measurements will be collected using a 14-day sleep diary and self-report measures. The participants who are eligible for actigraphy assessment will also be instructed to wear the device on their non-dominant wrist 24 hours a day for 14 consecutive days.
This group includes participants who do not meet the DSM-5 diagnostic criteria for current Major Depressive Disorder based the structured clinical interview SCID-5-RV. In this study, all participants will be given a structured clinical interview SCID-5-RV, complete the baseline assessment and then proceed to 14 days of monitoring of sleep, mood, and activity levels. Objective sleep measurements will be collected through actigraphy (e.g., ActiGraph accelerometer), while subjective sleep measurements will be collected using a 14-day sleep diary and self-report measures. The participants who are eligible for actigraphy assessment will also be instructed to wear the device on their non-dominant wrist 24 hours a day for 14 consecutive days.
Research Version of the Structured Clinical Interview for DSM-5 (SCID-5-RV)
A structured clinical interview for making the major DSM-5 diagnoses. This measure will be used to evaluate the presence of major depressive disorder and other psychiatric conditions, including subtypes of depression.
Time frame: Baseline
Change in Hospital Anxiety and Depression Scale (HADS)
A 14-item self-report scale used to measure the symptom severity of anxiety (7-item subscale) and depression (7-item subscale). The minimum score is 0 while maximum socre is 42. Higher scores indicate greater distress.
Time frame: Baseline, Day 7, Day 14
Change in Insomnia Severity Index (ISI)
A 7-item self-report scale commonly used to assess the perceived severity of insomnia. The minimum score is 0 while maximum socre is 28. Higher scores indicate greater distress.
Time frame: Baseline, Day 7, Day 14
Change in the Young Mania Rating Scale (YMRS)
An 11-item scale used to assess subjective manic symptoms. The minimum score is 0 while maximum socre is 60. Higher scores indicate greater distress.
Time frame: Baseline, Day 7, Day 14
Change in the Morningness-Eveningness Questionnaire (MEQ)
A 19-item self-report questionnaire used to measure the chronotype of human circadian rhythms. The minimum score is 16 while maximum socre is 86. Lower scores indicate eveningness, while higher scores indicate morningness.
Time frame: Baseline, Day 7, Day 14
Change in the Positive and Negative Affect Schedule (PANAS)
A 20-item scale commonly used to measure positive (10-item subscale) and negative affect (10-item subscale). Each item is rated on a 5-point Likert scale ranging from 1 to 5. Total scores on the scale range from 20 to 100, with higher scores on each subscale indicating greater levels of the respective affect. Specifically, a higher score on the positive affect subscale reflects higher levels of positive emotions, while a higher score on the negative affect subscale reflects higher levels of negative emotions.
Time frame: 14-day daily survey
Change in the Multidimensional Fatigue Inventory (MFI-20)
A 20-item scale used to assess five dimensions of fatigue, with each subscale score ranging from 4 to 20. The total score ranges from 20 to 100. Higher scores indicate more severe fatigue.
Time frame: Baseline, Day 7, Day 14
Change in the Short Form (6-Dimension) Health Survey (SF-6D)
A health survey used for measuring the quality of life on six dimensions. The scale is scored by converting participants' responses across six health dimensions into predefined utility weights and combining them using a standard multi-attribute algorithm to produce a single health-related quality-of-life score ranging from approximately 0.29 (worst) to 1.00 (full health). Higher scores indicate better health.
Time frame: Baseline, Day 7, Day 14
Change in sleep time
Recorded daily using the Consensus Sleep Diary.
Time frame: 14-day daily survey
Change in wake time
Recorded daily using the Consensus Sleep Diary.
Time frame: 14-day daily survey
Change in perceived sleeping quality
Recorded daily using the Consensus Sleep Diary. The minimum score is 1 while the maximum score is 4. Higher scores indicate better perceived sleeping quality.
Time frame: 14-day daily survey
Change in use of hypnotics
Recorded daily using the Consensus Sleep Diary.
Time frame: 14-day daily survey
Change in actigraphy-derived rest-activity pattern
24-hour rest-activity pattern will be collected using research-grade wearables (actigraphy), a validated physiological measurement tool that continuously records movement to estimate sleep-wake cycles. Participants will be instructed to wear the actigraphy on their non- dominant wrist, 24 hours a day, for 14 consecutive days, with exceptions during water sports activities.
Time frame: 14-day on a daily basis, 24 hours a day
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong