Cargando…

Adolescent depression: Study protocol for a randomized, controlled, double-blind multicenter parallel group trial of Bright Light Therapy in a naturalistic inpatient setting (DeLight)

BACKGROUND: Depressive disorders are among the most prominent health problems in youth. Even with the best available pharmacological and non-pharmacological treatments, remission rates are low. Without early treatment, depression in youth is associated with a high risk of symptom progression, chroni...

Descripción completa

Detalles Bibliográficos
Autores principales: Holtmann, Martin, Mokros, Laura, Kirschbaum-Lesch, Inken, Kölch, Michael, Plener, Paul L., Ruckes, Christian, Schulte-Markwort, Michael, Legenbauer, Tanja
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6194631/
https://www.ncbi.nlm.nih.gov/pubmed/30340625
http://dx.doi.org/10.1186/s13063-018-2949-0
_version_ 1783364264514289664
author Holtmann, Martin
Mokros, Laura
Kirschbaum-Lesch, Inken
Kölch, Michael
Plener, Paul L.
Ruckes, Christian
Schulte-Markwort, Michael
Legenbauer, Tanja
author_facet Holtmann, Martin
Mokros, Laura
Kirschbaum-Lesch, Inken
Kölch, Michael
Plener, Paul L.
Ruckes, Christian
Schulte-Markwort, Michael
Legenbauer, Tanja
author_sort Holtmann, Martin
collection PubMed
description BACKGROUND: Depressive disorders are among the most prominent health problems in youth. Even with the best available pharmacological and non-pharmacological treatments, remission rates are low. Without early treatment, depression in youth is associated with a high risk of symptom progression, chronicity, co-morbidity, and suicidal behavior. Thus, adolescent depression is a prime candidate for innovation in treatment. In depressive adults, meta-analytic evidence has proven that bright light therapy (BLT) is a potent low-threshold intervention, promising due to easy application, low side effects, and optimized compliance. In adolescents, studies with small samples show promising effects. This randomized controlled trial will examine the effectiveness of BLT in youth inpatients. METHODS/DESIGN: In this randomized, controlled, double-blind multicenter parallel group trial, morning BLT is applied for four weeks in addition to treatment as usual (TAU) for depressed youth inpatients (daily morning exposure to bright light via light-emitting glasses, 10,000 lx, for 30 min) and will be compared to a control condition (placebo light treatment, red light, identical light glasses). The primary objective is to assess whether BLT reduces symptoms of depression in youth with greater effect compared to placebo light therapy. Secondary objectives are to examine the impact of BLT on responder status, application of antidepressant medication, and further depression-related symptoms (sleep, activity, quality of life, satisfaction with health, general psychopathology, alertness, and circadian function). N = 224 patients will be recruited in a naturalistic inpatient setting. A follow-up will be carried out after three and six months. DISCUSSION: The study aims to discuss and evaluate BLT as an additive method supporting standardized clinical procedures dealing with severe to moderate depressive symptoms in youth. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00013188. Registered on November 30, 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2949-0) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-6194631
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-61946312018-10-25 Adolescent depression: Study protocol for a randomized, controlled, double-blind multicenter parallel group trial of Bright Light Therapy in a naturalistic inpatient setting (DeLight) Holtmann, Martin Mokros, Laura Kirschbaum-Lesch, Inken Kölch, Michael Plener, Paul L. Ruckes, Christian Schulte-Markwort, Michael Legenbauer, Tanja Trials Study Protocol BACKGROUND: Depressive disorders are among the most prominent health problems in youth. Even with the best available pharmacological and non-pharmacological treatments, remission rates are low. Without early treatment, depression in youth is associated with a high risk of symptom progression, chronicity, co-morbidity, and suicidal behavior. Thus, adolescent depression is a prime candidate for innovation in treatment. In depressive adults, meta-analytic evidence has proven that bright light therapy (BLT) is a potent low-threshold intervention, promising due to easy application, low side effects, and optimized compliance. In adolescents, studies with small samples show promising effects. This randomized controlled trial will examine the effectiveness of BLT in youth inpatients. METHODS/DESIGN: In this randomized, controlled, double-blind multicenter parallel group trial, morning BLT is applied for four weeks in addition to treatment as usual (TAU) for depressed youth inpatients (daily morning exposure to bright light via light-emitting glasses, 10,000 lx, for 30 min) and will be compared to a control condition (placebo light treatment, red light, identical light glasses). The primary objective is to assess whether BLT reduces symptoms of depression in youth with greater effect compared to placebo light therapy. Secondary objectives are to examine the impact of BLT on responder status, application of antidepressant medication, and further depression-related symptoms (sleep, activity, quality of life, satisfaction with health, general psychopathology, alertness, and circadian function). N = 224 patients will be recruited in a naturalistic inpatient setting. A follow-up will be carried out after three and six months. DISCUSSION: The study aims to discuss and evaluate BLT as an additive method supporting standardized clinical procedures dealing with severe to moderate depressive symptoms in youth. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00013188. Registered on November 30, 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2949-0) contains supplementary material, which is available to authorized users. BioMed Central 2018-10-19 /pmc/articles/PMC6194631/ /pubmed/30340625 http://dx.doi.org/10.1186/s13063-018-2949-0 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Holtmann, Martin
Mokros, Laura
Kirschbaum-Lesch, Inken
Kölch, Michael
Plener, Paul L.
Ruckes, Christian
Schulte-Markwort, Michael
Legenbauer, Tanja
Adolescent depression: Study protocol for a randomized, controlled, double-blind multicenter parallel group trial of Bright Light Therapy in a naturalistic inpatient setting (DeLight)
title Adolescent depression: Study protocol for a randomized, controlled, double-blind multicenter parallel group trial of Bright Light Therapy in a naturalistic inpatient setting (DeLight)
title_full Adolescent depression: Study protocol for a randomized, controlled, double-blind multicenter parallel group trial of Bright Light Therapy in a naturalistic inpatient setting (DeLight)
title_fullStr Adolescent depression: Study protocol for a randomized, controlled, double-blind multicenter parallel group trial of Bright Light Therapy in a naturalistic inpatient setting (DeLight)
title_full_unstemmed Adolescent depression: Study protocol for a randomized, controlled, double-blind multicenter parallel group trial of Bright Light Therapy in a naturalistic inpatient setting (DeLight)
title_short Adolescent depression: Study protocol for a randomized, controlled, double-blind multicenter parallel group trial of Bright Light Therapy in a naturalistic inpatient setting (DeLight)
title_sort adolescent depression: study protocol for a randomized, controlled, double-blind multicenter parallel group trial of bright light therapy in a naturalistic inpatient setting (delight)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6194631/
https://www.ncbi.nlm.nih.gov/pubmed/30340625
http://dx.doi.org/10.1186/s13063-018-2949-0
work_keys_str_mv AT holtmannmartin adolescentdepressionstudyprotocolforarandomizedcontrolleddoubleblindmulticenterparallelgrouptrialofbrightlighttherapyinanaturalisticinpatientsettingdelight
AT mokroslaura adolescentdepressionstudyprotocolforarandomizedcontrolleddoubleblindmulticenterparallelgrouptrialofbrightlighttherapyinanaturalisticinpatientsettingdelight
AT kirschbaumleschinken adolescentdepressionstudyprotocolforarandomizedcontrolleddoubleblindmulticenterparallelgrouptrialofbrightlighttherapyinanaturalisticinpatientsettingdelight
AT kolchmichael adolescentdepressionstudyprotocolforarandomizedcontrolleddoubleblindmulticenterparallelgrouptrialofbrightlighttherapyinanaturalisticinpatientsettingdelight
AT plenerpaull adolescentdepressionstudyprotocolforarandomizedcontrolleddoubleblindmulticenterparallelgrouptrialofbrightlighttherapyinanaturalisticinpatientsettingdelight
AT ruckeschristian adolescentdepressionstudyprotocolforarandomizedcontrolleddoubleblindmulticenterparallelgrouptrialofbrightlighttherapyinanaturalisticinpatientsettingdelight
AT schultemarkwortmichael adolescentdepressionstudyprotocolforarandomizedcontrolleddoubleblindmulticenterparallelgrouptrialofbrightlighttherapyinanaturalisticinpatientsettingdelight
AT legenbauertanja adolescentdepressionstudyprotocolforarandomizedcontrolleddoubleblindmulticenterparallelgrouptrialofbrightlighttherapyinanaturalisticinpatientsettingdelight