Bright Light Therapy for Adolescents With Depression and Eveningness - a Randomized, Placebo-controlled, Assessor-blinded Study
| Registry | NCT06973759 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 90 (Estimated) |
| Sponsor | Chinese University of Hong Kong (Other) |
| Conditions | Depression, Unipolar |
| Interventions | Bright light therapy, Dim red light (Device) |
| Dates | start 2025-11-01, primary completion 2028-06-30 (estimated), completion 2028-06-30 (estimated), first posted 2025-05-15, last updated 2026-03-19 |
| Locations | 1 site in Hong Kong |
Related Papers Related Patents Related Grants Related Experts
All trials for Depression, Unipolar All trials of Bright light therapy All trials of Dim red light
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Bright light therapy group | Experimental | Device: Bright light therapy | Blue-enriched white light |
| Dim red light group | Placebo comparator | Device: Dim red light | Dim red light |
Sex: All, ages: 12 Years to 19 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong, Hong Kong | Hong Kong | Recruiting |