Depression, UnipolarDELAYNCT06092411
Effects of CBT and BLT in Youth With Unipolar Depression and Evening Chronotype
A study testing Cognitive Behavioural Therapy for Depression and Bright Light Therapy in people with Depression, Unipolar and Eveningness, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Depression, Unipolar, Eveningness
- What is being tested?
- Cognitive Behavioural Therapy for Depression and Bright Light Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Oct 2023to 20 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
Shirley Xin Li, Dr, +852 3917-7035, shirley.li@hku.hk
About this study
Official title: 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
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:
- What is the efficacy of CBT-D and CBT-D plus bright light therapy in reducing depression severity in adolescents with depression and eveningness?
- 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.
Read the detailed description
Adolescence is a vulnerable period often linked to the emergence of emotional and behavioural difficulties, particularly major depressive disorder (MDD). It is also associated with a gradual change of circadian rhythm characterised by an intrinsic phase delay with an increased evening preference linked to pubertal development. The optimal treatment for youth depression remains controversial. CBT for depression (CBT-D) is one of the most extensively tested psychological treatments for managing mild to moderate depression. Nonetheless, well-designed randomised controlled trials (RCTs) of CBT-D conducted in young people were limited, and the existing research showed that more than 60% of youth did not respond to psychological treatments. Therefore, improving the current model of care and outcomes in youth with depression is imperative, yet rigorous controlled trials of the treatment for youth depression remain limited. In addition, despite the close interplay between circadian disruption and mood problems, little is known as to whether the adjunctive circadian-focused intervention could potentially enhance the treatment outcome of adolescent depression, especially in those with circadian vulnerability (eveningness).
The study is a randomised controlled trial that examines the effects of cognitive behavioural therapy and bright light therapy in youth with unipolar depression and evening chronotype. Eligible participants will be randomised to one of the following groups: CBT-D plus bright light therapy (CBTD+BLT), CBT for depression only (CBTD-BLT), or waiting list control (WL) using an automated online system. For both treatment groups, the intervention will consist of 8 weekly group sessions (90-min, 4-6 adolescents in each group) of CBT-D delivered in the afternoon/evening after school within a 10-week window. The intervention is structured and based on the well-established CBT elements for treating depression, which combines cognitive and behavioural strategies targeting the common difficulties and problems encountered by depressed adolescents. Participants in both treatment groups will also be introduced to the daily light-based intervention by wearing a portable light device (Re-timers) at home for 30 minutes daily for seven weeks, starting from the second week of the group intervention. Participants in the CBTD-BLT group will receive a placebo light intervention, where they will be exposed to dim red light (50 lux), whereas participants in the CBT-D plus light therapy group will receive the active light treatment. All participants initially randomised to the WL condition will be offered treatment opportunities at the end of the WL period.
The primary aim of the study is to test the efficacy of CBT-D and CBT-D plus bright light therapy in reducing depression severity in adolescents with depression and eveningness when compared with the waiting list control. The secondary aim of the study is to examine 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 measures of quality of life, daytime symptoms and functioning (e.g., sleepiness, fatigue).
- Conditions
- Depression, Unipolar, Eveningness
- Being tested
- Cognitive Behavioural Therapy for Depression, Bright Light Therapy
- Keywords
- Depression, Eveningness, Adolescents, Bright Light Therapy, Cognitive Behavioural Therapy
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy for DepressionBehavioural
Consists 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 TherapyDevice
Participants 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).
| Study group | Role | What they receive |
|---|---|---|
| CBT for Depression + Bright Light Therapy (CBTD+BLT) | Experimental | N = 54 Receives: Behavioral: Cognitive Behavioural Therapy for Depression; Device: Bright Light Therapy |
| CBT for Depression + Placebo Light (CBTD-BLT) | Active comparator | N = 54 Receives: Behavioral: Cognitive Behavioural Therapy for Depression |
| Waitlist Control (WL) | No intervention | N = 54 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 groups
Secondary outcomes (23)
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.
Measured: 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 groups
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.
Measured: 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 groups
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.
Measured: 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 groups
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.
Measured: 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 groups
Change in Insomnia Symptoms
Insomnia Severity Index (ISI) is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
Measured: 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 groups
Change in Sleep Quality
Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale consisting of 19 questions. All items are combined to form seven component scores on different aspects of sleep quality, each of which ranges from 0 to 3 points with higher scores representing more sleep disturbance. The seven component scores are added to one global score, which ranges from 0 to 21, with higher scores indicating more difficulties with sleep.
Measured: 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 groups
Change in Total Sleep Time (TST) measured by sleep diary
Daily sleep diary for seven consecutive days. Total sleep time (hours) was estimated by averaging the recorded days.
Measured: 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 groups
Change in Sleep Onset Latency (SOL) measured by sleep diary
Daily sleep diary for seven consecutive days. Sleep onset latency (minutes) was estimated by averaging the recorded days.
Measured: 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 groups
Change in Wake After Sleep Onset (WASO) measured by sleep diary
Daily sleep diary for seven consecutive days. Wake after sleep onset (minutes) was estimated by averaging the recorded days.
Measured: 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 groups
Change in Sleep Efficiency (SE) measured by sleep diary
Daily sleep diary for seven consecutive days. Sleep efficiency (in percentage, calculated by total sleep time divided by total time in bed) was estimated by averaging the recorded days.
Measured: 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 groups
Change in Total Sleep Time (TST) measured by actigraphy
Actigraphy assessment for seven consecutive days. Total sleep time (hours) was estimated by averaging the recorded days.
Measured: 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 groups
Change in Sleep Onset Latency (SOL) measured by actigraphy
Actigraphy assessment for seven consecutive days. Sleep onset latency (minutes) was estimated by averaging the recorded days.
Measured: 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 groups
Change in Wake After Sleep Onset (WASO) measured by actigraphy
Actigraphy assessment for seven consecutive days. Wake after sleep onset (minutes) was estimated by averaging the recorded days.
Measured: 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 groups
Change in Sleep Efficiency (SE) measured by actigraphy
Actigraphy assessment for seven consecutive days. Sleep efficiency (in percentage, calculated by total sleep time divided by total time in bed) was estimated by averaging the recorded days.
Measured: 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 groups
Change in Actigraphic Circadian Measures - L5 computed by nonparametric circadian rhythm analysis
Actigraphic assessment for seven consecutive days. The start times and average activity of L5 (i.e., five hours of least activity within a 24-hour period) is computed by the nonparametric circadian rhythm analysis.
Measured: 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 groups
Change in Actigraphic Circadian Measures - M10 computed by nonparametric circadian rhythm analysis
Actigraphic assessment for seven consecutive days. The start times and average activity of M10 (i.e., 10 hours of maximal activity within a 24-hour period) is computed by the nonparametric circadian rhythm analysis.
Measured: 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 groups
Change in Actigraphic Circadian Measures - acrophase computed by cosinor analysis
Actigraphic assessment for seven consecutive days. The acrophase (defined as time of maximum activity express as clock time) is computed by cosinor analysis.
Measured: 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 groups
Change in Actigraphic Circadian Measures - amplitude computed by cosinor analysis
Actigraphic assessment for seven consecutive days. The amplitude (defined as the differences in distance from the peak to the nadir) is computed by cosinor analysis.
Measured: 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 groups
Change in Actigraphic Circadian Measures - MESOR computed by cosinor analysis
Actigraphic assessment for seven consecutive days. The MESOR (defined as the mean activity level) is computed by cosinor analysis.
Measured: 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 groups
Change in Objective Physiological Circadian Measures
Home-based dim-light melatonin onset assessment (expressed as time value hh:mm) is determined by 10-hour salivary melatonin collected at 30-minute intervals.
Measured: Baseline, one-week post-treatment/Week 9
Change in Daytime Sleepiness
Paediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-rated scale measuring daytime sleepiness, ranging in total scores from 0 to 32 with higher scores indicating more sleepiness.
Measured: 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 groups
Change in Daytime Fatigue
Multidimensional Fatigue Inventory (MFI) is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. In all cases, a higher score represents higher fatigue symptoms.
Measured: 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 groups
Change in Quality of Life
KIDSCREEN-27 is a 27-item self-rated scale measuring health related quality of life measure for children and adolescents. There are five subscales on: physical well-being (possibly scored from 5 to 25), psychological well-being (possibly scored 7 to 35), autonomy \& parents (possibly scored 7 to 35), peers \& social support (possibly scored 4 to 20), and school environment (possibly scored 4 to 20). A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being.
Measured: 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 groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start31 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, UnipolarStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Dr. Shirley Xin Li, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092411
- Sponsor's protocol ID
- EA220381
- Acronym
- DELAY
- Status last verified
- Apr 2024
- First submitted
- 19 Sep 2023
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06092411
- Acronym / sponsor ID
- DELAY / EA220381
- Conditions
- Depression, Unipolar, Eveningness
- Keywords
- Depression, Eveningness, Adolescents, Bright Light Therapy, Cognitive Behavioural Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the efficacy of CBT-D and CBT-D plus bright light therapy in reducing depression severity in adolescents with depression and eveningness?
- 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.
Detailed description
Adolescence is a vulnerable period often linked to the emergence of emotional and behavioural difficulties, particularly major depressive disorder (MDD). It is also associated with a gradual change of circadian rhythm characterised by an intrinsic phase delay with an increased evening preference linked to pubertal development. The optimal treatment for youth depression remains controversial. CBT for depression (CBT-D) is one of the most extensively tested psychological treatments for managing mild to moderate depression. Nonetheless, well-designed randomised controlled trials (RCTs) of CBT-D conducted in young people were limited, and the existing research showed that more than 60% of youth did not respond to psychological treatments. Therefore, improving the current model of care and outcomes in youth with depression is imperative, yet rigorous controlled trials of the treatment for youth depression remain limited. In addition, despite the close interplay between circadian disruption and mood problems, little is known as to whether the adjunctive circadian-focused intervention could potentially enhance the treatment outcome of adolescent depression, especially in those with circadian vulnerability (eveningness).
The study is a randomised controlled trial that examines the effects of cognitive behavioural therapy and bright light therapy in youth with unipolar depression and evening chronotype. Eligible participants will be randomised to one of the following groups: CBT-D plus bright light therapy (CBTD+BLT), CBT for depression only (CBTD-BLT), or waiting list control (WL) using an automated online system. For both treatment groups, the intervention will consist of 8 weekly group sessions (90-min, 4-6 adolescents in each group) of CBT-D delivered in the afternoon/evening after school within a 10-week window. The intervention is structured and based on the well-established CBT elements for treating depression, which combines cognitive and behavioural strategies targeting the common difficulties and problems encountered by depressed adolescents. Participants in both treatment groups will also be introduced to the daily light-based intervention by wearing a portable light device (Re-timers) at home for 30 minutes daily for seven weeks, starting from the second week of the group intervention. Participants in the CBTD-BLT group will receive a placebo light intervention, where they will be exposed to dim red light (50 lux), whereas participants in the CBT-D plus light therapy group will receive the active light treatment. All participants initially randomised to the WL condition will be offered treatment opportunities at the end of the WL period.
The primary aim of the study is to test the efficacy of CBT-D and CBT-D plus bright light therapy in reducing depression severity in adolescents with depression and eveningness when compared with the waiting list control. The secondary aim of the study is to examine 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 measures of quality of life, daytime symptoms and functioning (e.g., sleepiness, fatigue).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT for Depression + Bright Light Therapy (CBTD+BLT) | Experimental | Behavioral: Cognitive Behavioural Therapy for Depression, Device: Bright Light TherapyN = 54 |
| CBT for Depression + Placebo Light (CBTD-BLT) | Active comparator | Behavioral: Cognitive Behavioural Therapy for DepressionN = 54 |
| Waitlist Control (WL) | No intervention | –N = 54 |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy for DepressionConsists 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. | Behavioural | CBT for Depression + Bright Light Therapy (CBTD+BLT), CBT for Depression + Placebo Light (CBTD-BLT) |
| Bright Light TherapyParticipants 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). | Device | CBT for Depression + Bright Light Therapy (CBTD+BLT) |
Primary outcome
Change in Assessor-rated 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 groups
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.
23 secondary outcomes
Change of Self-report 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 groups
Change of Suicidal Ideation
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 groups
Change in Self-Report Chronotype Measures
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 groups
Change in Self-Report Circadian Typology
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 groups
Change in Insomnia 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 groups
Change in Sleep Quality
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 groups
Change in Total Sleep Time (TST) measured by sleep diary
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 groups
Change in Sleep Onset Latency (SOL) measured by sleep diary
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 groups
Change in Wake After Sleep Onset (WASO) measured by sleep diary
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 groups
Change in Sleep Efficiency (SE) measured by sleep diary
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 groups
Change in Total Sleep Time (TST) measured by actigraphy
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 groups
Change in Sleep Onset Latency (SOL) measured by actigraphy
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 groups
Change in Wake After Sleep Onset (WASO) measured by actigraphy
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 groups
Change in Sleep Efficiency (SE) measured by actigraphy
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 groups
Change in Actigraphic Circadian Measures - L5 computed by nonparametric circadian rhythm analysis
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 groups
Change in Actigraphic Circadian Measures - M10 computed by nonparametric circadian rhythm analysis
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 groups
Change in Actigraphic Circadian Measures - acrophase computed by cosinor analysis
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 groups
Change in Actigraphic Circadian Measures - amplitude computed by cosinor analysis
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 groups
Change in Actigraphic Circadian Measures - MESOR computed by cosinor analysis
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 groups
Change in Objective Physiological Circadian Measures
Time frame: Baseline, one-week post-treatment/Week 9
Change in Daytime Sleepiness
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 groups
Change in Daytime Fatigue
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 groups
Change in Quality of Life
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 groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy for Depression and Bright Light Therapy in people with Depression, Unipolar and Eveningness, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirley X Li, DClinPsy (+852 39177035, shirley.li@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Assessor-rated 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 groups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.