Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study

Carlo Volf, Anne Sofie Aggestrup, Paul Michael Petersen, Carsten Dam-Hansen, Ulla Knorr, Ema Erkocevic Petersen, Janus Engstrøm, Janus C Jakobsen, Torben Skov Hansen, Helle Østergaard Madsen, Ida Hageman, Klaus Martiny, Carlo Volf, Anne Sofie Aggestrup, Paul Michael Petersen, Carsten Dam-Hansen, Ulla Knorr, Ema Erkocevic Petersen, Janus Engstrøm, Janus C Jakobsen, Torben Skov Hansen, Helle Østergaard Madsen, Ida Hageman, Klaus Martiny

Abstract

Introduction: Retrospective studies conducted in psychiatric inpatient wards have shown a relation between the intensity of daylight in patient rooms and the length of stay, pointing to an antidepressant effect of ambient lighting conditions. Light therapy has shown a promising antidepressant effect when administered from a light box. The emergence of light-emitting diode (LED) technology has made it possible to build luminaires into rooms and to dynamically mimic the spectral and temporal distribution of daylight. The objective of this study is to investigate the antidepressant efficacy of a newly developed dynamic LED-lighting system installed in an inpatient ward.

Methods and analysis: In all, 150 inpatients with a major depressive episode, as part of either a major depressive disorder or as part of a bipolar disorder, will be included. The design is a two-arm 1:1 randomised study with a dynamic LED-lighting arm and a static LED-lighting arm, both as add-on to usual treatment in an inpatient psychiatric ward. The primary outcome is the baseline adjusted score on the 6-item Hamilton Depression Rating Scale at week 3. The secondary outcomes are the mean score on the Suicidal Ideation Attributes Scale at week 3, the mean score on the 17-item Hamilton Depression Rating Scale at week 3 and the mean score on the World Health Organisation Quality of Life-BREF (WHOQOL-BREF) at week 3. The spectral distribution of daylight and LED-light, with a specific focus on light mediated through the intrinsically photosensitive retinal ganglion cells, will be measured. Use of light luminaires will be logged. Assessors of Hamilton Depression Rating Scale scores and data analysts will be blinded for treatment allocation. The study was initiated in May 2019 and will end in December 2021.

Ethics and dissemination: No ethical issues are expected. Results will be published in peer-reviewed journals, disseminated electronically and in print and presented at symposia.

Trial registration number: NCT03821506; Pre-results.

Keywords: bipolar disorder; chronotherapy; inpatients; light; lighting; major depressive disorder; randomised controlled trial.

Conflict of interest statement

Competing interests: TSH is an employee of Chromaviso that has supplied the lighting system.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
The left-hand picture shows how the light-emitting diode panel is mimicking sunlight reflections on the wall. The right-hand side of the picture shows natural sunlight reflexions on the wall.
Figure 2
Figure 2
The temporal distribution of horizontal (A) and vertical (B) α-opic irradiance of the light-emitting diode (LED)-lighting with daylight blacked out. Dynamic LED-light intervention is shown as solid lines and static LED-light intervention is shown as dashed lines. Measurement points and equipment are described in the ‘Light measurement’ section. The depicted timelines are for the summer intervention profile. Winter intervention profile differs in the way that the period between 06:00 and 18:00 during summer is contracted 1 hour in each end to 07:00 and 17:00 to enhance patient tolerability.
Figure 3
Figure 3
The placement of the luminaries where A is the light-emitting diode (LED) panel built into the window jamb, B is the two ceiling luminaires and C is the reading luminaire. Mv and Mh indicates the measurement point for the vertical (Mv) and horizontal (Mh) spectral LED measurements performed in a patient room with blackout blind in the window to exclude daylight. SL indicates the permanent placement of the illuminance- and the spectral room sensors and SDL the permanent placement of the spectral daylight sensor.

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