Actively Recruiting
Effects of Cognitive Behavioural Therapy and Bright Light Therapy in Youth With Unipolar Depression and Evening Chronotype: An Assessor-blind Parallel-group Randomised Controlled Trial
Led by The University of Hong Kong · Updated on 2024-04-22
162
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
Sponsors
T
The University of Hong Kong
Lead Sponsor
C
Chinese University of Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are examining the effects of cognitive behavioural therapy for depression (CBT-D) and bright light therapy on adolescents aged 12 to 20 years with unipolar depression and an evening chronotype. The study aims to determine how these treatments affect depression severity, sleep patterns, circadian rhythms, quality of life, daytime symptoms such as sleepiness and fatigue, and overall functioning. This is a randomised controlled trial sponsored by The University of Hong Kong, focusing on youth with depression and eveningness. Participants will be randomly assigned to one of three groups: CBT-D plus bright light therapy, CBT-D plus placebo light, or a waiting list control. The active treatments involve eight weekly group sessions of CBT-D, each lasting 90 minutes and held in the afternoon or evening after school. Starting from the second week, participants in both treatment groups will use a portable light device daily at home for 30 minutes over seven weeks. Those in the bright light therapy group receive active blue-green light, while the CBT-D only group receives dim red placebo light. Participants on the waiting list will have the opportunity to receive treatment after the waiting period. During the study, researchers will assess changes in depression symptoms using observer ratings and self-reports at baseline, one week post-treatment, and follow-ups at one and six months for treated participants. Sleep and circadian measures will be tracked through diaries and actigraphy, alongside evaluations of suicidal thoughts, sleep quality, daytime sleepiness and fatigue, and quality of life. The study involves regular monitoring and aims to provide a detailed picture of treatment effects over time, with total participation spanning up to six months after treatment.
CONDITIONS
Brief Title
Effects of CBT and BLT in Youth With Unipolar Depression and Evening Chronotype
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese youth aged 12 to 20 years
- Written informed consent provided by participant and parent/guardian if under 18
- Ability to follow the study protocol
- Diagnosis of depressive disorders according to DSM-5
- Score of 40 or higher on Children's Depression Rating Scale (CDRS-R)
- Evening chronotype defined by a score of 41 or lower on the Morning-Eveningness Questionnaire (MEQ)
- Sleep onset time of 11:15pm or later for 12 year olds, 11:30pm or later for 13-14 year olds, and midnight or later for 15-20 year olds at least 3 nights per week in the past 3 months
You will not qualify if you...
- Current substance abuse or dependence
- History of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities
- Medication changes affecting circadian rhythm within past 3 months (e.g., lithium, melatonin)
- Clinically significant suicidality with plan or attempt
- Participation in other clinical trials within one month before study entry
- Recent start or change in antidepressant medication within past 3 months
- Current or past structured psychotherapy
- Hearing or speech impairments
- Night shift work
- Trans-meridian flight in past month or during intervention
- Eye diseases such as retinal blindness, severe cataract, or glaucoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 weeks
Participants receive 8 weekly group sessions of cognitive behavioural therapy for depression and use a portable light device daily at home for 7 weeks starting from the second week of therapy. The light therapy involves either bright blue-green light or placebo dim red light, depending on group assignment.
Weekly group sessions for up to 8 weeks and daily light therapy at home for 7 weeks
Duration - 6 months
After treatment ends, participants in the treatment groups have follow-up assessments to monitor changes in depressive symptoms, sleep, circadian measures, and quality of life.
Assessments at 1 month and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
S
Shirley X Li, DClinPsy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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