NCT06092411 Effects of CBT and BLT in Youth With Unipolar Depression and Evening Chronotype
| NCT ID | NCT06092411 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Depression, Unipolar |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 162 participants in total. It began in 2023-10-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. The main questions it aims to answer are: 1. What is the efficacy of CBT-D and CBT-D plus bright light therapy in reducing depression severity in adolescents with depression and eveningness? 2. What are the effects of CBT-D and CBT-D plus bright light therapy on the subjective and objective sleep and circadian measures, as well as the quality of life, daytime symptoms, and functioning (e.g., sleepiness, fatigue)? Participants will participate in 8 weekly group sessions of CBT-D intervention based on the well-established CBT elements for treating depression. Concurrently participants will also be asked to wear a portable light device at home for 30 minutes daily for seven weeks, starting from the second week of the group intervention. Participants in the CBT-D only group will receive a placebo light via the device, whereas participants in the CBT-D plus light therapy group will receive the active bright light via the device.
Eligibility Criteria
Inclusion Criteria: 1. Chinese aged 12-20 years old. 2. Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18). 3. Being able to comply with the study protocol. 4. Having a DSM-5 diagnosis of depressive disorders. 5. Having a score of ≥ 40 on Children's Depression Rating Scale (CDRS-R). 6. Having a score of ≤ 41 on Horne-Östberg Morning-Eveningness Questionnaire (MEQ; classified as evening chronotype). 7. 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 Criteria: 1. 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. 2. Initiation of and change of medication that may interfere with circadian rhythm within past 3 months (e.g., lithium, exogenous melatonin, melatonergic antidepressants). 3. In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt). 4. Having been enrolled in any other clinical trial investigational products within one month at the entry of the study. 5. Initiation of or change in antidepressant medication within past 3 months. 6. Having been or is currently receiving any structured psychotherapy. 7. With hearing or speech deficit. 8. Night shift worker. 9. Trans-meridian flight in the past 1 month and during intervention. 10. Presence of an eye disease (e.g., retinal blindness, severe cataract, glaucoma).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06092411 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 20 Years, studying Depression, Unipolar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06092411 currently recruiting?
Yes, NCT06092411 is actively recruiting participants. Contact the research team at shirley.li@hku.hk for enrollment information.
Where is the NCT06092411 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06092411 clinical trial?
NCT06092411 is sponsored by The University of Hong Kong. The trial plans to enroll 162 participants.
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