BioClock: Bright Light Therapy for Depressive Disorders

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.

Conditions

• Depression, Unipolar
• Depression, Bipolar

Interventions

PROCEDURE

Bright 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).

DEVICE

Blue Light Blocking Glasses

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

Sponsors & Collaborators

• Eindhoven University of Technology

  collaborator OTHER

• Geestelijke Gezondheidszorg Eindhoven (GGzE)

  collaborator OTHER

• Chrono@Work B.V.

  collaborator UNKNOWN

• Universiteit Leiden

  lead OTHER

Principal Investigators

• Niki Antypa, PhD · Leiden University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-08

Primary Completion

2026-09-30

Completion

2026-12-31

Countries

• Netherlands

Study Locations