Longitudinal Ecological Study on Sleep-Wake Patterns in MDD Using Actigraphy
NCT ID: NCT06233422
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
140 participants
OBSERVATIONAL
2024-06-30
2026-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No intervention involved
No intervention involved
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.
No intervention involved
No intervention involved
Interventions
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No intervention involved
No intervention involved
Eligibility Criteria
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Inclusion Criteria
* Being fluent and literate in Cantonese
* A Patient Health Questionnaire-9 (PHQ-9) score of below 5, indicating minimal or no depressive symptoms
* Accessibility to an Internet-enabled mobile device (iOS or Android operating system)
* Willingness to provide informed consent and comply with the trial protocol.
* Adults aged 18-65 years living in Hong Kong
* Being fluent and literate in Cantonese
* A PHQ-9 score of at least 10, indicating a moderate level of depression.
* Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI)
* Experiencing ≥ 1 sleep or circadian problem in the past 3 months according to the sleep and circadian problems checklist (i.e., time needed to fall asleep ≥ 30 minutes, wake after sleep onset ≥ 30 minutes, \< 6-hour sleep per night or ≥ 9-hour sleep per night per 24-hour period, and falling asleep after 2:00 AM ≥ 3 nights per week; and variability in the sleep-wake schedule ≥ 2.78 hours within a week)
* Access to an Internet-enabled mobile device (iOS or Android operating system)
* Willingness to provide informed consent and comply with the trial protocol.
Exclusion Criteria
* Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns
* Presence of other untreated sleep disorders based on cut-off scores of individual sections in SLEEP-50.
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.
* Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience
* Presence of other psychiatric disorders as assessed by MINI
* A history of electroconvulsive therapy (ECT)
* Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems
* A change in the class or dose of any prescribed psychotropic drugs within 6 weeks before the baseline assessment
* Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns
* Presence of other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) based on the cut-off scores of SLEEP-50 (narcolepsy ≥ 7; OSA ≥ 15; RLS/PLMD ≥ 7)
18 Years
65 Years
ALL
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Fiona YY Ho
Associate Professor
Locations
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The Chinese University of Hong Kong
Shatin, , Hong Kong
Countries
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Other Identifiers
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PSY033
Identifier Type: -
Identifier Source: org_study_id
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