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

Trials, vol. 26, pp. 411

Abstract

BACKGROUND: Bright 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. METHODS: This 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 REGISTRATION: Registered on July 14, 2023, at clinicaltrials.gov under number NCT05958940.

Authors 11

1. Esther Visser corresponding

   Eindhoven University of Technology

   Affiliation as printed

   Human 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

   Human Technology Interaction group, Department of Industrial Engineering and Innovation Sciences, Eindhoven University of Technology, Den Dolech 2, 5612 AZ, Eindhoven, The Netherlands

2. Oana Georgiana Rus-Oswald Aachen Department of Clinical Psychology Faculty of Social Sciences

   Leiden University

   Affiliation as printed

   Department of Clinical Psychology, Faculty of Social Sciences, Leiden University, Wassenaarseweg 2, 2333 AK, Leiden, The Netherlands

3. Willem A. J. van der Does Aachen

   Leiden University

   Affiliation as printed

   Leids Universitair Behandel- en Expertise Centrum, Sandifortdreef 17, Leiden, 2333 ZZ, The Netherlands

4. Marijke C. M. Gordijn

   University of Groningen

   Affiliation as printed

   Chrono@Work B.V., Friesestraatweg 213, Groningen, 9743 AD, The Netherlands

   Chronobiology Unit, Groningen Institute for Evolutionary Life Sciences, University of Groningen, Nijenborgh 7, Groningen, 9747 AG, The Netherlands

5. Machteld C. Marcelis

   Maastricht University · GGzE

   Affiliation as printed

   Department of Psychiatry and Neuropsychology, Mental Health and Neuroscience Research Institute, Maastricht University, Minderbroedersberg 4-6 , Maastricht, 6211 LK, The Netherlands

   GGzE Mental Health Institute of Eindhoven and the Kempen, Eindhoven, 5626 ND, Dokter Poletlaan 40, The Netherlands

6. Yvonne A. W. de Kort

   Eindhoven University of Technology

   Affiliation as printed

   Human Technology Interaction group, Department of Industrial Engineering and Innovation Sciences, Eindhoven University of Technology, Den Dolech 2, 5612 AZ, Eindhoven, The Netherlands

7. Priscilla P. Oomen

   Radboud University Nijmegen

   Affiliation as printed

   Behavioural Science Institute, Radboud University, Nijmegen, The Netherlands

8. Luc J. M. Schlangen

   Eindhoven University of Technology

   Affiliation as printed

   Human Technology Interaction group, Department of Industrial Engineering and Innovation Sciences, Eindhoven University of Technology, Den Dolech 2, 5612 AZ, Eindhoven, The Netherlands

9. T. Seetsen

   GGzE

   Affiliation as printed

   GGzE Mental Health Institute of Eindhoven and the Kempen, Eindhoven, 5626 ND, Dokter Poletlaan 40, The Netherlands

10. Claudia J.P. Simons

    Maastricht University · GGzE

    Affiliation as printed

    Department of Psychiatry and Neuropsychology, Mental Health and Neuroscience Research Institute, Maastricht University, Minderbroedersberg 4-6 , Maastricht, 6211 LK, The Netherlands

    GGzE Mental Health Institute of Eindhoven and the Kempen, Eindhoven, 5626 ND, Dokter Poletlaan 40, The Netherlands

11. Niki Antypa Aachen Department of Clinical Psychology Faculty of Social Sciences

    Leiden University

    Affiliation as printed

    Department of Clinical Psychology, Faculty of Social Sciences, Leiden University, Wassenaarseweg 2, 2333 AK, Leiden, The Netherlands