Effects of CBT and BLT in Youth With Unipolar Depression and Evening Chronotype

NCT06092411 | Recruiting

• 1 other identifier: EA220381
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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)?

Conditions

Depression, Unipolar; Eveningness

Keywords

Depression; Eveningness; Adolescents; Bright Light Therapy; Cognitive Behavioural Therapy

Outcome Measures

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.

  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

  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

  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

  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

  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

  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

Study Arms (3)

CBT for Depression + Bright Light Therapy (CBTD+BLT)

EXPERIMENTAL

N = 54

Behavioral: Cognitive Behavioural Therapy for Depression; Device: Bright Light Therapy

CBT for Depression + Placebo Light (CBTD-BLT)

ACTIVE COMPARATOR

N = 54

Behavioral: Cognitive Behavioural Therapy for Depression

Waitlist Control (WL)

NO INTERVENTION

N = 54

Interventions

Cognitive Behavioural Therapy for Depression BEHAVIORAL

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.

CBT for Depression + Bright Light Therapy (CBTD+BLT); CBT for Depression + Placebo Light (CBTD-BLT)

Bright Light Therapy DEVICE

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).

CBT for Depression + Bright Light Therapy (CBTD+BLT)

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

Cognitive Behavioral Therapy; Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Phototherapy; Therapeutics

Central Study Contacts

Shirley X Li, DClinPsy

CONTACT

+852 39177035; shirley.li@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 23, 2023
• Study Start: October 31, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): October 20, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

HK (1)