Evidence map›Paper›PMID 41088238›Full record

ArticleTrials2025

BioClock-optimizing Bright Light Therapy for adults with depression: a study protocol for a multicenter randomized clinical trial on treatment strategies, response predictors, and chronobiological and neurobiological mechanisms.

E Visser, O G Rus-Oswald, A J W van der Does, M C M Gordijn, M C Marcelis, Y A W de Kort, P P Oomen, L J M Schlangen, T Seetsen, C J P Simons and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05958940 (BioClock), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05958940 narecruitingnot on this map

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

TypeinterventionalSponsorUniversiteit LeidenRan2024 to 2026Enrolled231ConditionsDepression, Unipolar, Depression, BipolarArmsBright Light Therapy, Blue Light Blocking Glasses
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

E VisserHuman Technology Interaction group, Department of Industrial Engineering and Innovation Sciences, Eindhoven University of Technology, Den Dolech 2, 5612 AZ, Eindhoven, The Netherlands. e.visser1@tue.nl.
O G Rus-OswaldDepartment of Clinical Psychology, Faculty of Social Sciences, Leiden University, Wassenaarseweg 2, 2333 AK, Leiden, The Netherlands.
A J W van der DoesLeids Universitair Behandel- en Expertise Centrum, Sandifortdreef 17, Leiden, 2333 ZZ, The Netherlands.
M C M GordijnChrono@Work B.V., Friesestraatweg 213, Groningen, 9743 AD, The Netherlands.
M C MarcelisGGzE Mental Health Institute of Eindhoven and the Kempen, Eindhoven, 5626 ND, Dokter Poletlaan 40, The Netherlands.
Y A W de KortHuman Technology Interaction group, Department of Industrial Engineering and Innovation Sciences, Eindhoven University of Technology, Den Dolech 2, 5612 AZ, Eindhoven, The Netherlands.
P P OomenBehavioural Science Institute, Radboud University, Nijmegen, The Netherlands.
L J M SchlangenHuman Technology Interaction group, Department of Industrial Engineering and Innovation Sciences, Eindhoven University of Technology, Den Dolech 2, 5612 AZ, Eindhoven, The Netherlands.
T SeetsenGGzE Mental Health Institute of Eindhoven and the Kempen, Eindhoven, 5626 ND, Dokter Poletlaan 40, The Netherlands.
C J P SimonsGGzE Mental Health Institute of Eindhoven and the Kempen, Eindhoven, 5626 ND, Dokter Poletlaan 40, The Netherlands.
N AntypaDepartment of Clinical Psychology, Faculty of Social Sciences, Leiden University, Wassenaarseweg 2, 2333 AK, Leiden, The Netherlands.

Funding

Nederlandse Organisatie voor Wetenschappelijk Onderzoek NWA.1292.19.077
6 · The paper itself

Abstract

backgroundBright Light Therapy (BLT) is an effective treatment for various mood disorders, but challenges remain in optimizing its real-world administration, predicting individual responses, and understanding its mechanisms.

methodsThis multicenter randomized controlled trial will enroll 231 patients with unipolar or bipolar depression, all currently experiencing a depressive episode. Participants will be randomized to one of three BLT interventions: (1) traditional home-based BLT, (2) BLT administered in the LightCafé-a novel setting promoting social interaction and lifestyle support, or (3) LightCafé BLT with personalized timing of both light and darkness by adding the use of blue light blocking glasses. The treatment duration will range from one to three weeks, based on preset definitions of participant's response. The primary outcome is the change in depressive symptoms, assessed by a blinded rater. Secondary outcomes include subjective and objective sleep measures, circadian rhythm parameters from melatonin patterns and actigraphy, and functional outcomes. Change processes will be assessed using ecological momentary assessments of daily affect and energy levels, light exposure sensors, and via brain imaging. DISCUSSION: This trial is the first to directly compare different BLT administration models, including a LightCafé setting. It aims to identify predictors of BLT response, investigate chronobiological and neurobiological mechanisms, and provide insights to optimize BLT for diverse patient populations. The results will inform clinical guidelines and enhance BLT's accessibility and effectiveness.

trial registrationRegistered on July 14, 2023, at clinicaltrials.gov under number NCT05958940.

Indexed as

Bipolar DisorderDepressionPhototherapyActigraphyAdultCircadian RhythmFemaleHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicSleepTime FactorsTreatment OutcomeBright Light TherapyChronobiologyDepressionEcological Momentary AssessmentMagnetic resonance imagingMelatoninMood disordersSleep

Identifiers

PMID41088238
PMCPMC12523188

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.