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

NCT06092411 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2024-04-22

No results posted yet for this study

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. 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.

Conditions

  • Depression, Unipolar
  • Eveningness

Interventions

BEHAVIORAL

Cognitive Behavioural Therapy for Depression

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.

DEVICE

Bright Light Therapy

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).

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2025-12-31
Completion
2026-10-20

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06092411 on ClinicalTrials.gov