Bright Light Therapy for Adolescents With Depression and Eveningness - a Randomized, Placebo-controlled, Assessor-blinded Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change of depressive symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The subjects will be explained that the study aims to test the efficacy of the different modalities of non-pharmacological treatments for depression including bright light therapy and dim red light, without mentioning which one is the placebo. An independent outcome assessor will be blinded to the treatment allocation throughout the study.
Eligibility Criteria
- Ages
- 12 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chinese, aged 12-19 years old;
- •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;
- •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;
- •Being classified as evening chronotype according to the score on the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ), i.e. <12.
Exclusion Criteria
- •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;
- •Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by K-SADS;
- •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 4 weeks;
- •Having been or is currently receiving any structured psychotherapy;
- •With hearing or speech deficit;
- •Night shift worker;
- •Trans-meridian flight across at least two time zones in the past 3 months and during the study;
- •Presence of an eye disease, e.g., retinal blindness, severe cataract, glaucoma.
Arms & Interventions
Bright light therapy group
Blue-enriched white light
Intervention: Bright light therapy (Device)
Dim red light group
Dim red light
Intervention: Dim red light (Device)
Outcomes
Primary Outcomes
Change of depressive symptoms
Time Frame: Soon after the intervention
Change in the score of the Children's Depression Rating Scale (CDRS-R), which ranges from 17-113, higher score indicates higher severity of depression.
Secondary Outcomes
- Change of other clinical symptoms(Soon after the intervention)
Investigators
Joey WY Chan
Clinical Associate Professor
Chinese University of Hong Kong