RecruitingNot ApplicableNCT05958940

BioClock: Bright Light Therapy for Depressive Disorders

BioClock: Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders - a Multicentre Randomized Controlled Trial


Sponsor

Universiteit Leiden

Enrollment

231 participants

Start Date

Feb 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Bright Light Therapy (BLT) is a proven treatment for depression in seasonal and non-seasonal depressive disorders, as well as bipolar disorder. To make BLT more effective and practical in clinical settings and tailor it to individual needs, it is necessary to optimize the treatment approach, understand how the treatment works, and identify patient characteristics that predict response. This clinical trial has three main goals: * Optimize the administration of BLT for patients with depressive episodes. * Gain a deeper understanding of the treatment mechanisms. * Determine which patients benefit the most from the treatment. The specific objectives are as follows: * Investigate whether additional treatments and interventions related to lifestyle and the biological clock can enhance the effects of BLT. * Examine how BLT influences the body's internal clock and sleep quality, and how these factors contribute to the outcomes. * Identify patient characteristics and behaviours that can predict treatment outcomes. * Develop a brain model to better understand the impact of BLT on the brain. In this study, patients will receive BLT with a light intensity of 10,000 lux for 30 minutes each morning over 5 consecutive days. The treatment duration will range from one to three weeks, depending on the improvement of depressive symptoms. Participants will be randomly assigned to one of three groups: * Home - Patients will receive BLT at home, following the standard guidelines for light therapy in the Netherlands. * LightCafé, fixed time: Patients will receive BLT in a café-like setting called the LightCafé, where the focus is not only on symptom improvement but also lifestyle enhancements and fostering social connections. The treatment time will be the same every day. * LightCafé, varying time: Patients will also receive BLT at the LightCafé, with treatment timing varying each day. Additionally, this group will wear glasses in the evening that filter blue light. The study includes a baseline phase of up to two weeks, a treatment phase of up to three weeks, and a three-month follow-up phase. Patients will wear a motion watch to assess sleep-wake behaviour and physical activity during the day. Additionally, they will wear a broach that measures their personal light exposure throughout the day. Eight one-minute questionnaires per day will be sent to the participants' smartphones to assess vitality, sleep, and mood during the treatment. Predictors of treatment response, such as clinical characteristics, sleep measures, circadian parameters, and light-related behaviours, will be evaluated at baseline. In a small group of patients, salivary melatonin curves will be assessed before and after treatment. MRI scans will provide insights into functional and structural brain changes following light therapy treatment.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether bright light therapy — sitting in front of a specially designed light box each day — can reduce depression in people with unipolar or bipolar depression. Called the BioClock trial, it examines how light exposure helps reset the body's internal clock and improves mood. **You may be eligible if...** - You are 18 to 65 years old with a confirmed diagnosis of unipolar or bipolar depression (seasonal or non-seasonal) - You are currently experiencing a depressive episode (moderate or greater severity) - You understand Dutch or English well enough to complete questionnaires **You may NOT be eligible if...** - You are currently in a manic, hypomanic, or psychotic episode - You have prominent active suicidal thoughts - You started a new antidepressant, psychotherapy, or light therapy within the past 2 months - You use melatonin, antibiotics, or medications that increase light sensitivity - You have traveled across time zones or worked night shifts recently - You have certain eye conditions (glaucoma, severe cataracts, retinal disease) or skin conditions worsened by light - You are pregnant, or you have a child younger than 18 months old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBright Light Therapy

In this study, Bright Light Therapy (BLT) will be administered according to Dutch depression guidelines, using Innolux LED light lamp (3800K, 10,000 lux). BLT will be given for one work week (Mon-Fri), 7:30-10:30 AM, 30 mins/session. Patients can have breakfast, read, or use devices. Treatment effectiveness will be evaluated using Self-Rated Quick Inventory of Depressive Symptoms (QIDS-SR). If remission is achieved (QIDS-SR \< 6), no additional treatment is given. If response is insufficient (QIDS-SR ≥ 6), 5 more sessions will be added in the following week, with maximum two extensions (1-3 weeks total).

DEVICEBlue Light Blocking Glasses

Plastic, orange-coloured glasses that primarily block blue light. To be worn in the evening.


Locations(2)

GGzE - Mental Health Institute of Eindhoven and the Kempen

Eindhoven, Netherlands

Leids Universitair Behandel- en Expertise Centrum

Leiden, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05958940


Related Trials