Adjunctive Bright Light Therapy in Adolescents With Depression and Eveningness

NCT ID: NCT06973759

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2028-06-30

Brief Summary

This study examines the efficacy of bright light therapy as a treatment for adolescents diagnosed with unipolar non-seasonal depression who exhibit an evening chronotype.

Detailed Description

This randomized, placebo-controlled, assessor-blinded trial aims to evaluate the efficacy of bright light therapy (BLT) as a treatment for adolescents with depression and evening chronotype. Eligible participants will be randomized to receive either BLT or dim red light (placebo) daily for 8 weeks. Depression severity, sleep parameters, and circadian markers will be assessed at baseline, during treatment, post-treatment, and at follow-up visits.

Conditions

Depression, Unipolar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bright light therapy group

Blue-enriched white light

Group Type: EXPERIMENTAL

Bright light therapy

Intervention Type: DEVICE

Exposure to blue-enriched white light for 15-30 minutes a day for 8 weeks

Dim red light group

Dim red light

Group Type: PLACEBO_COMPARATOR

Dim red light

Intervention Type: DEVICE

Exposure to dim red light for 15-30 minutes a day for 8 weeks.

Interventions

Bright light therapy

Exposure to blue-enriched white light for 15-30 minutes a day for 8 weeks

Intervention Type: DEVICE

Dim red light

Exposure to dim red light for 15-30 minutes a day for 8 weeks.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Chinese, aged 12-19 years old;

2. Written informed assent/consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18), respectively;

3. Having a DSM-5 diagnosis of unipolar non-seasonal depression as confirmed by the Chinese version of the Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS) psychiatric interview, DSM-5 Seasonal specifier, AND having a score on Children's Depression Rating Scale (CDRS-R) at least 40;

4. Being classified as evening chronotype according to the score on the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ), i.e. <12.

Exclusion Criteria

1. A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, organic mental disorders, or intellectual disabilities;

2. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by K-SADS;

3. Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;

4. Initiation of or change in antidepressant medication within past 4 weeks;

5. Having been or is currently receiving any structured psychotherapy;

6. With hearing or speech deficit;

7. Night shift worker;

8. Trans-meridian flight across at least two time zones in the past 3 months and during the study;

9. Presence of an eye disease, e.g., retinal blindness, severe cataract, glaucoma.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Joey WY Chan

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

Countries

Hong Kong

Central Contacts

Joey WY Chan

Role: CONTACT

joeywychan@cuhk.edu.hk

+852 39197647

Facility Contacts

Joey WY Chan, FHKAM(Psych)

Role: primary

joeywychan@cuhk.edu.hk

+862 39197647

Xingle Gao

Role: backup

xinglegao@link.cuhk.edu.hk

+852 92916602

Other Identifiers

12230316

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024.494-T

Identifier Type: -

Identifier Source: org_study_id