Longitudinal Ecological Study on Sleep-Wake Patterns in MDD Using Actigraphy

Launched by CHINESE UNIVERSITY OF HONG KONG · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying sleep patterns in people with Major Depressive Disorder (MDD) to better understand how sleep affects their mental health. The research will involve two parts: the first part will track the sleep and wake habits of 140 participants for four weeks using a small device that monitors their movements while they sleep. This group will include 70 individuals diagnosed with MDD and 70 healthy individuals of similar age and gender for comparison. Researchers aim to see how different sleep patterns relate to the severity of depression and to explore if targeted sleep therapies can improve mood in those with MDD.

To participate, individuals with MDD must be between 18-65 years old, fluent in Cantonese, and have moderate levels of depression as measured by a specific questionnaire. Healthy participants should also be within the same age range and show minimal signs of depression. Everyone will need access to a smartphone and must agree to follow the study guidelines. The trial is not yet recruiting, but it represents an important step toward understanding how sleep impacts depression and finding new ways to help those affected.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for Healthy Control Group:
• • Adults aged 18 to 65 years living in Hong Kong
• • 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.
• Exclusion Criteria for Healthy Control Group:
• • Presence of any psychiatric disorder(s) as assessed by MINI
• • 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.
• Inclusion Criteria for the Major Depressive Disorder (MDD) group:
• • 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 for the Major Depressive Disorder (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)