Actively Recruiting
Led by Universiteit Leiden · Updated on 2025-01-09
231
Participants Needed
2
Research Sites
13 weeks
Total Duration
U
Universiteit Leiden
Lead Sponsor
E
Eindhoven University of Technology
Collaborating Sponsor
Researchers are studying Bright Light Therapy (BLT) to improve treatment for people experiencing depressive episodes, including unipolar and bipolar depression. The trial aims to optimize how BLT is given, understand how it works in the body, and identify which patients benefit most. It seeks to explore whether lifestyle changes and biological clock adjustments can enhance BLT's effects and develop a brain model to see how BLT influences the brain. Participants receive BLT using a 10,000 lux light lamp for 30 minutes each morning over 5 consecutive days. The treatment lasts between one and three weeks, depending on symptom improvement. Patients are randomly assigned to one of three groups: receiving BLT at home following standard guidelines, receiving BLT in a specialized café that promotes lifestyle and social interaction with fixed daily timing, or receiving BLT in the café with varied timing plus wearing blue light blocking glasses in the evening. Before, during, and after treatment, participants wear devices to monitor sleep, activity, and light exposure. They also complete frequent mood and vitality questionnaires via smartphone. Researchers assess clinical and biological factors that may predict treatment response, including brain scans for functional and structural changes. The study includes a baseline phase up to two weeks, a treatment phase up to three weeks, and a three-month follow-up to evaluate clinical improvement and other outcomes.
CONDITIONS
BioClock: Bright Light Therapy for Depressive Disorders
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 3 weeks
Participants receive Bright Light Therapy sessions Monday to Friday mornings for one work week. If depressive symptoms do not sufficiently improve, additional treatment sessions may be added in one to three weekly extensions. Some participants also wear blue light blocking glasses in the evening and follow personalized therapy timing based on their sleep-wake patterns.
5 to 15 sessions over 1 to 3 weeks (in-person or supervised depending on group assignment)
Duration - Up to 4 months
Participants are monitored for changes in depressive symptoms, sleep quality, and circadian rhythms up to approximately 4 months after starting treatment.
Periodic assessments during follow-up period
Total: 2 locations
1
GGzE - Mental Health Institute of Eindhoven and the Kempen
Eindhoven, Netherlands, 5626 ND
Actively Recruiting
2
Leids Universitair Behandel- en Expertise Centrum
Leiden, Netherlands, 5626 ND
Actively Recruiting
N
Niki Antypa, PhD
L
Luc Schlangen, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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E Visser, O G Rus-Oswald, A J W van der Does...
https://pubmed.ncbi.nlm.nih.gov/41088238