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The proposed study will include a longitudinal ecological study (Study 1) and a randomised controlled trial (Study 2). The aims will be to (1) identify the sleep-wake profiles in individuals with Major Depressive Disorder (MDD) through clustering; (2) examine the associations between sleep-wake features/profiles and the prognosis of MDD; and (3) investigate the anti-depressant effects of sleep- and circadian-targeted intervention in those with MDD and whether sleep-wake features/profiles may moderate the treatment outcomes.
In Study 1, a total of 140 participants comprising 70 participants with MDD and 70 age- and gender-matched healthy controls will be recruited. Sleep-wake patterns will be collected for 4 consecutive weeks using actigraphy devices and one-off self-report measures will be collected via an in-house smartphone application, PsyHub.
Study 1 and 2 will follow the CONSORT and STROBE guidelines, respectively. The current registration is only for Study 1 of the current research project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Major Depressive Disorder (MDD) Group | MDD group will consist of 70 participants with MDD, aged between 18-65, with a Patient Health Questionnaire-9 (PHQ-9) score of at least 10; who are also experiencing at least 1 sleep or circadian problem in the past 3 months. |
| |
| Healthy Control Group | Healthy control group will consist of 70 healthy control participants, aged between 18-65, with a Patient Health Questionnaire-9 (PHQ-9) score of below 5, indicating minimal or no depressive symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention involved | Other | No intervention involved |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) | A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression, by scoring each item from "0" (not at all) to "3" (nearly everyday), total severity scale ranging from 0 to 27. | 1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1 |
| Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep onset latency (SOL) | Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, SOL is one of the sleep parameters which will be measured by Actigraphy. | 24-hour wear time for 4 consecutive weeks |
| Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - wake after sleep onset (WASO) | Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, WASO is one of the sleep parameters which will be measured by Actigraphy. | 24-hour wear time for 4 consecutive weeks |
| Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - total sleep time (TST) | Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, TST is one of the sleep parameters which will be measured by Actigraphy. | 24-hour wear time for 4 consecutive weeks |
| Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep efficiency (SE) | Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, SE is one of the sleep parameters which will be measured by Actigraphy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale (HADS) | A 14-item scale measuring anxiety and depression in both hospital and community settings. | 1 at baseline, and 1 at the end of study 1 |
| Change in Insomnia Severity Index (ISI) |
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Inclusion Criteria for Healthy Control Group:
Exclusion Criteria for Healthy Control Group:
We will not exclude those with current suicidal risks (i.e., non-fleeting intent or plan), which is a common symptom of MDD. However, if serious suicidal risk (i.e., PHQ-9 Item 9 score > 2) is identified, the participant will be referred to the PI (a clinical psychologist) for further assessment and professional mental health services if deemed necessary.
Inclusion Criteria for the Major Depressive Disorder (MDD) group:
Exclusion Criteria for the Major Depressive Disorder (MDD) group:
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Community sample, if recruitment in the community is insufficient, we will recruit participants from our collaborating outpatient clinics, non-governmental organizations, and community centers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
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| 24-hour wear time for 4 consecutive weeks |
| Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - fragmentation index (FI) | Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, FI is one of the sleep parameters which will be measured by Actigraphy. | 24-hour wear time for 4 consecutive weeks |
| Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - time in bed (TIB) | Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, TIB is one of the sleep parameters which will be measured by Actigraphy. | 24-hour wear time for 4 consecutive weeks |
| Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - number of awakenings (NOA) | Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, NOA is one of the sleep parameters which will be measured by Actigraphy. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using non-parametric approach - interdaily stability (IS) | IS is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using non-parametric approach - intradaily variability (IV) | IV is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using non-parametric approach - relative amplitude (RA) | RA is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using non-parametric approach - the least active 5 hours (L5) | L5 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using non-parametric approach - the most active 10 hours (M10) | M10 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using extended cosinor approach - amplitude | Rhythm height (amplitude) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the difference between the peak and nadir of the rhythm. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using extended cosinor approach - mesor | Rhythm height (mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the 24-hour adjusted mean rhythm activity, | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using extended cosinor approach - acrophase | Rhythm timing (acrophase) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the time of peak rhythm activity. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using extended cosinor approach - up-mesor | Rhythm timing (up-mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the activity initiation time. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using extended cosinor approach - down-mesor | Rhythm timing (down-mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the time of activity offset. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using extended cosinor approach - alpha | Rhythm shape (alpha) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the width of the rhythm. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using extended cosinor approach - beta | Rhythm shape (beta) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the steepness of the fitted curve. | 24-hour wear time for 4 consecutive weeks |
| Variability in sleep-wake variables using extended cosinor approach - pseudo F-statistic | Rhythm robustness (pseudo F-statistic) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the goodness of extended cosine fit. | 24-hour wear time for 4 consecutive weeks |
A 7-item scale used to assess the perceived severity of insomnia.
| 1 at baseline, and 1 at the end of study 1 |
| Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI) | 8-item scales to assess sleep and circadian functions. | 1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1 |
| Change in Multidimensional Fatigue Inventory (MFI) | A 20-item scale used to assess five dimensions of fatigue. | 1 at baseline, and 1 at the end of study 1 |
| Change in Short Form (6-Dimension) Health Survey (SF-6D) | A health survey used for measuring the quality of life on six dimensions. | 1 at baseline, and 1 at the end of study 1 |
| Change in Sheehan Disability Scale (SDS) | A 5-item scale used to assess functional impairments in work/ school, social life, and family life. | 1 at baseline, and 1 at the end of study 1 |
| Change in Core Consensus Standardized Sleep Diary | A 9-item scale used to record sleep time, wake time, perceived sleeping quality, and use of hypnotics. | 4-week daily survey |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009784 | Occupational Diseases |
| D001523 | Mental Disorders |