BioClock: Optimizing Bright Light Therapy and Understanding Its Effects for Depressive Disorders A Randomized Controlled Study of Treatment Timing, Lifestyle Factors, and Brain Impact

What this Trial Is About

Researchers are evaluating Bright Light Therapy (BLT) as a treatment for depressive episodes in people with unipolar and bipolar depression, including seasonal and non-seasonal types. The study aims to optimize BLT administration, understand how it works, and identify which patients respond best. It explores how additional lifestyle and biological clock interventions might boost BLT's effects, how BLT affects the body's internal clock and sleep, and seeks to develop a brain model to understand BLT's impact on brain function. Participants will receive BLT using a 10,000 lux light intensity for 30 minutes every morning over 5 consecutive days, with treatment lasting between one and three weeks based on symptom improvement. They will be randomly assigned to one of three groups: receiving BLT at home following standard guidelines, receiving BLT in a cafe9-like setting with fixed daily treatment times to promote lifestyle and social benefits, or receiving BLT in the same setting with varying treatment times plus wearing blue light blocking glasses in the evening. Treatment sessions occur Monday to Friday between 7:30 and 10:30 AM. During the study, participants will wear devices to monitor sleep-wake patterns, physical activity, and personal light exposure. They will complete brief questionnaires on vitality, sleep, and mood multiple times daily via smartphone. Clinical characteristics, sleep, circadian rhythms, and light-related behaviors will be assessed at baseline. A subset will have saliva tests for melatonin levels and MRI scans to examine brain changes. The study includes up to two weeks of baseline, up to three weeks of treatment, and a three-month follow-up phase, measuring clinical improvement within 2 to 5 weeks.

BioClock: Bright Light Therapy for Depressive Disorders