Status:
RECRUITING
Effects of CBT and BLT in Youth With Unipolar Depression and Evening Chronotype
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Chinese University of Hong Kong
Conditions:
Depression, Unipolar
Eveningness
Eligibility:
All Genders
12-20 years
Phase:
NA
Brief Summary
The goal of this prospective randomised controlled trial is to examine the effects of cognitive behavioural therapy and bright light therapy in youths with unipolar depression and evening chronotype. ...
Detailed Description
Adolescence is a vulnerable period often linked to the emergence of emotional and behavioural difficulties, particularly major depressive disorder (MDD). It is also associated with a gradual change of...
Eligibility Criteria
Inclusion
- Chinese aged 12-20 years old.
- Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18).
- Being able to comply with the study protocol.
- Having a DSM-5 diagnosis of depressive disorders.
- Having a score of ≥ 40 on Children's Depression Rating Scale (CDRS-R).
- Having a score of ≤ 41 on Horne-Östberg Morning-Eveningness Questionnaire (MEQ; classified as evening chronotype).
- Having a sleep onset time of 11:15pm or later for 12 year olds, 11:30pm or later for 13-14 year olds, and 12:00pm or later for 15-20 years at least 3 nights per week in the past 3 months.
Exclusion
- A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities.
- Initiation of and change of medication that may interfere with circadian rhythm within past 3 months (e.g., lithium, exogenous melatonin, melatonergic antidepressants).
- In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt).
- Having been enrolled in any other clinical trial investigational products within one month at the entry of the study.
- Initiation of or change in antidepressant medication within past 3 months.
- Having been or is currently receiving any structured psychotherapy.
- With hearing or speech deficit.
- Night shift worker.
- Trans-meridian flight in the past 1 month and during intervention.
- Presence of an eye disease (e.g., retinal blindness, severe cataract, glaucoma).
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2026
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06092411
Start Date
October 31 2023
End Date
October 20 2026
Last Update
April 22 2024
Active Locations (1)
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1
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, Hong Kong