Effects of CBT and BLT in Youth With Unipolar Depression and Evening Chronotype
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-20
SponsorThe University of Hong Kong
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cognitive Behavioural Therapy for Depression
- Bright Light Therapy
Treatment groups
162 Participants
are divided into 3 treatment groupsSponsors and collaborators
The University of Hong Kong
Lead sponsor
Chinese University of Hong Kong
Collaborator
Source ClinicalTrials.gov