Status:
UNKNOWN
A Transdiagnostic Sleep and Circadian Treatment for Major Depressive Disorder
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
University of California, Berkeley
Conditions:
Major Depressive Disorder
Sleep Disturbance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will examine the use of a transdiagnostic Sleep and Circadian Treatment (TranS-C) in treating Major Depressive Disorder (MDD) in Chinese adults. Sleep disturbance is highly comorbid with a ...
Eligibility Criteria
Inclusion
- Hong Kong Citizen who is able to speak Cantonese and read Chinese;
- Aged ≥ 18 years;
- Presence of the DSM-IV diagnostic criteria of MDD based on Chinese-bilingual Structured Clinical Interview for DSM-IV (SCID);
- Score on PHQ-9 is 10 or above;
- More than 1 sleep or circadian problem according to the Sleep and Circadian Problem Checklist, including time needed to fall asleep more than 30 minutes for more than 3 nights per week, less than 6 hours of sleep per night or at least 9 hour of sleep per night per 24 hour period for at least 3 nights per week, variability in the sleep-wake schedule at least 2.78 hours within a week, and falling asleep after 2 am on at least 3 nights per week;
- Adequate opportunity and circumstances for sleep to occur; and
- Willing to give informed consent and comply with the trial protocol.
Exclusion
- Presence of other psychiatric disorders as defined by the DSM-IV diagnostic criteria using SCID;
- Major medical or neurocognitive disorders that make participation infeasible;
- Have suicidal ideation based on Beck Depression Inventory (BDI-II) Item 9 score ≥ 2;
- Untreated sleep disorders based on SLEEP-50 (≥ 7 on narcolepsy; ≥ 15 on OSA; ≥ 7 on RLS/PLMD);
- Past or current involvement in a psychological treatment programme for depression and/or sleep problems;
- Shift work, pregnancy, work, family, or other commitments that interfere with regular night-time sleep patterns;
- Hospitalization; and
- A change in psychotropic drugs within 2 weeks before baseline assessment
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03786731
Start Date
January 1 2019
End Date
June 1 2021
Last Update
March 11 2020
Active Locations (1)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong