Sleep-Wake Patterns on Illness Trajectories and Treatment Response in MDD

Launched by CHINESE UNIVERSITY OF HONG KONG · Dec 22, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how sleep patterns affect people with Major Depressive Disorder (MDD) and how specific treatments might help. The study has two parts: first, researchers will look at different sleep-wake profiles in individuals with depression to see how these profiles relate to their mental health. Then, they will test a new treatment aimed at improving sleep and daily rhythms in people with MDD, comparing it to usual care. The trial will involve 70 participants, who will be randomly assigned to either receive the new treatment or continue with standard care for 8 weeks.

To take part in this study, participants must be adults aged 18-65 living in Hong Kong, able to read and speak Cantonese, and have a moderate level of depression as measured by a questionnaire. They should also have experienced sleep problems in the last three months. Participants will need access to a smartphone and be willing to follow the trial guidelines. Importantly, this study will provide the treatment at no cost. If you're interested in participating, it's a great opportunity to potentially improve your sleep and mood while contributing to important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for the MDD group:
• • 1. Adults aged 18-65 years living in Hong Kong
• • 2. Being fluent and literate in Cantonese
• • 3. A Patient Health Questionnaire-9 (PHQ-9) score of at least 10, indicating a moderate level of depression.
• • 4. Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI)
• • 5. 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)
• • 6. Access to an Internet-enabled mobile device (iOS or Android operating system)
• • 7. Willingness to provide informed consent and comply with the trial protocol.
• Exclusion Criteria for the MDD group:
• • 1. Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience
• • 2. Presence of other psychiatric disorders as assessed by MINI
• • 3. A history of electroconvulsive therapy (ECT)
• • 4. Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems
• • 5. A change in the class or dose of any prescribed psychotropic drugs within 6 weeks before the baseline assessment
• • 6. Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns
• • 7. 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)