Effects of CBT and BLT in Youth With Unipolar Depression and Evening Chronotype
Recruiting · NCT06092411 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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).
Where it is running
1 location listed.
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong - Hong Kong, Hong Kong