Status:
NOT_YET_RECRUITING
Sleep-Wake Patterns on Illness Trajectories and Treatment Response in MDD
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Depression
Sleep Disorders, Circadian Rhythm
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 MDD ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for the MDD group:
- Adults aged 18-65 years living in Hong Kong
- Being fluent and literate in Cantonese
- A Patient Health Questionnaire-9 (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 for the MDD group:
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06181110
Start Date
June 1 2024
End Date
January 1 2026
Last Update
May 30 2024
Active Locations (1)
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1
The Chinese University of Hong Kong
Shatin, Hong Kong