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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioural Therapy for Depression
BehavioralConsists of 8 weekly sessions (group-based, 90-min, 4-6 adolescents in each group). The intervention focuses on addressing depression, with the components such as psycho-education on depression, self-monitoring, behavioural activation, and cognitive restructuring (addressing negative and irrational thoughts often associated with depression in adolescents), relaxation techniques, and relapse prevention.
Bright Light Therapy
DeviceParticipants will undergo daily morning light therapy by wearing a validated portable light emitting device (i.e., Re-Timers: https://www.re-timer.com/) at home for 30 minutes. Participants will receive bright blue-green light (500 nm, 506 lux).
Treatment groups
162 Participants
are divided into 3 treatment groupsGroup A: CBT for Depression + Bright Light Therapy (CBTD+BLT)Experimental treatment 2 interventions
Group B: CBT for Depression + Placebo Light (CBTD-BLT)Active comparator 1 intervention
Group C: Waitlist Control (WL)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Assessor-rated Depressive Symptoms
Children's Depression Rating Scale (CDRS-R) is a 17-item rating scale based on a semi-structured interview with children. Possible scores range from 17 to 113, with higher scores indicating severer depressive symptoms.
Time frame
Baseline and one-week post-treatment/Week 9 for all participants, and post-treatment 1-month follow-up and post-treatment 6-month follow-up for the participants in the treatment groupsSecondary outcomes
1
Change of Self-report Depressive Symptoms
Beck's Depression Inventory (BDI-II) is a 21-item self-report rating scale measuring depression symptoms. Possible scores range from 0 to 62, with higher scores indicating more severe depressive symptoms.
Time frame
Baseline and one-week post-treatment/Week 9 for all participants, and post-treatment 1-month follow-up and post-treatment 6-month follow-up for the participants in the treatment groups2
Change of Suicidal Ideation
The Beck's Suicide Ideation Scale (BSSI) is a 19-item self-report rating scale measuring suicide ideation. Possible scores range from 0 to 38, with higher scores indicating higher suicide intention.
Time frame
Baseline and one-week post-treatment/Week 9 for all participants, and post-treatment 1-month follow-up and post-treatment 6-month follow-up for the participants in the treatment groups3
Change in Self-Report Chronotype Measures
Munich Chronotype Questionnaire (MCTQ) is a self-report measures of sleeping patterns during weekdays and weekends separately. The Mid-Sleep Time (MSF/MSFsc) are used to as an indicator of chronotype, where individuals with earlier mid-sleep time reflect a morning chronotype and later mid-sleep time reflect an evening chronotype.
Time frame
Baseline and one-week post-treatment/Week 9 for all participants, and post-treatment 1-month follow-up and post-treatment 6-month follow-up for the participants in the treatment groups4
Change in Self-Report Circadian Typology
The Morningness-Eveningness Questionnaire (MEQ) is a 19-item self-report rating scale measuring circadian preference (typology). Possible scores range from 16 to 89, with lower scores indicating preference towards eveningness. Based on the conventional cut off, having a MEQ score of 16-41 is considered eveningness.
Time frame
Baseline and one-week post-treatment/Week 9 for all participants, and post-treatment 1-month follow-up and post-treatment 6-month follow-up for the participants in the treatment groupsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Chinese University of Hong Kong
Collaborator
Source ClinicalTrials.gov