Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Martin Holtmann, Laura Mokros, Inken Kirschbaum-Lesch, Michael Kölch, Paul L. Plener, Christian Ruckes, Michael Schulte-Markwort, Tanja Legenbauer

Published in: Trials | Issue 1/2018

Login to get access

Abstract

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.
Appendix
Available only for authorised users
Literature
1.
Ravens-Sieberer U, Wille N, Erhart M, Bettge S, Wittchen H-U, Rothenberger A, et al. Prevalence of mental health problems among children and adolescents in Germany: results of the BELLA study within the National Health Interview and Examination Survey. Eur Child Adolesc Psychiatry. 2008;17(1):22–33.CrossRef
2.
Birmaher B, Brent D, Bernet W, Bukstein O, Walter H, Benson RS, et al. Practice parameter for the assessment and treatment of children and adolescents with depressive disorders. J Am Acad Child Adolesc Psychiatry. 2007;46(11):1503–26.CrossRef
3.
Bettge S, Wille N, Barkmann C, Schulte-Markwort M, Ravens-Sieberer U. BELLA study Group. Depressive symptoms of children and adolescents in a German representative sample. Eur Child Adolesc Psychiatry. 2008;7(1):71–81.CrossRef
4.
Harrington R, Fudge H, Rutter M, Pickles A, Hill J. Adult outcomes of childhood and adolescent depression. Arch Gen Psychiatry. 1990;47:465–73.CrossRef
5.
Steinhausen HC, Gundelfinger R, Winkler Metzke C. Prevalence of self-reported seasonal affective disorders and the validity of the seasonal pattern assessment questionnaire in young adults. Findings from a Swiss community study. J Affect Disord. 2009;115:347–54.CrossRef
6.
Holtmann M, Duketis E, Poustka L, Zepf FD, Poustka F, Bölte S. Bipolar disorder in children and adolescents in Germany: National trends in the rates of inpatients, 2000–2007. Bipolar Disorder. 2010;12:155–63.CrossRef
7.
8.
Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jönsson B, et al. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011;21:655–79.CrossRef
9.
Emslie GJ, Kennard BD, Mayes TL, Nakonezny PA, Zhu L, Tao R, et al. Insomnia moderates outcome of serotonin-selective reuptake inhibitor treatment in depressed youth. J Child Adolesc Psychopharmacol. 2012;22(1):21–8.CrossRef
10.
Kennard B, Silva S, Vitiello B, Curry J, Kratochvil C, Simons A, et al. Remission and residual symptoms after short term treatment in the treatment of adolescents with depression study (TADS). J Am Acad Child Adolesc Psychiatry. 2006;45:1404–11.CrossRef
11.
Emslie GJ, Mayes T, Porta G, Vitiello B, Clarke G, Wagner KD, et al. Treatment of resistant depression in adolescents (TORDIA): week 24 outcomes. Am J Psychiatry. 2010;167(7):782–91.CrossRef
12.
13.
Holtmann M, Bolte S, Poustka F. Suicidality in depressive children and adolescents during treatment with selective serotonin reuptake inhibitors: Review and meta-analysis of the available randomised, placebo controlled trials. Nervenarzt. 2006;77:1332–7.CrossRef
14.
Fegert JM, Kölch M, Zito JM, Glaeske G, Jahnsen K. Antidepressant use in children and adolescents in Germany. J Child Adolesc Psychopharmacol. 2006;16:197–206.CrossRef
15.
Dolle K, Schulte-Körner G. The treatment of depressive disorders in children and adolescents. Dtsch Ärztebl Int. 2013;110(50):854–60.PubMedPubMedCentral
16.
Bogen S, Legenbauer T, Bogen T, Gest S, Jensch T, Schneider S, et al. Morning light therapy for juvenile depression and severe mood dysregulation: study protocol for a randomized controlled trial. Trials. 2013;14(1):178.CrossRef
17.
Gest S, Legenbauer T, Bogen S, Schulz C, Pniewski B, Holtmann M. Chronotherapeutics: an alternative treatment of juvenile depression. Med Hypotheses. 2014;82(3):346–9.CrossRef
18.
Al-Karawi D, Jubair L. Bright light therapy for nonseasonal depression: Meta analysis of clinical trials. J Affect Disord. 2016;198:64–71.CrossRef
19.
Tuunainen A, Kripke D, Endo T. Light therapy for non-seasonal depression. Cochrane Database Syst Rev. 2004;(2):CD004050.
20.
Popper CW. Mood disorders in youth: exercise, light therapy, and pharmacologic complementary and integrative approaches. Child Adolesc Psychiatr Clin N Am. 2013;22:403–41.CrossRef
21.
Bogen S, Legenbauer T, Gest S, Holtmann M. Lighting the mood of depressed youth: Feasibility and efficacy of a 2 week-placebo controlled bright light treatment for juvenile Inpatients. J Affect Disord. 2016;190:450–6.CrossRef
22.
Legenbauer T, Heiler S, Holtmann M, Fricke-Oerkermann L, Lehmkuhl G. The affective storms of school children during night time: Do affective dysregulated school children show a specific pattern of sleep disturbances? J Neural Transm. 2012;119:989–98.CrossRef
23.
Gest S, Holtmann M, Bogen S, Schulz C, Pniewski B, Legenbauer T. Chronotherapeutic treatments for depression in youth. Eur Child Adolesc Psychiatry. 2016;25(2):151–61.CrossRef
24.
25.
Moscovici L, Kotler M. A multistage chronobiologic intervention for the treatment of depression: A pilot study. J Affect Disord. 2009;116:201–7.CrossRef
26.
Viola A, Hubbard J, Comtet H, Hubbard I, Delloye E, Ruppert E, et al. Beneficial effect of morning light after one night of sleep deprivation: Light glasses versus light box administration. Vienna, Austria: Poster. Society for Light Treatment and Biological Rhythms. Annual Meeting; 2014.
27.
28.
Lam RW, Levitt AJ, Levitan RD, Enns MW, Morehouse R, Michalak EE, et al. The Can-SAD study: a randomized controlled trial of the effectiveness of light therapy and fluoxetine in patients with winter seasonal affective disorder. Am J Psychiatry. 2006;163:805–12.CrossRef
29.
Dilling H, Freyberger HJ. Taschenführer zur Klassifikation psychischer Störungen: ICD-10. Bern: Hogrefe; 1994.
30.
Horne JA, Östberg O. A self-assessment questionnaire to determine morningness–eveningness in human circadian rhythms. Chronobiol Int. 1976;4:97–110.
31.
Wirz-Justice A, Benedetti F, Terman M. Chronotherapeutics for affective disorders: a clinican’s manual for light and wake therapy. 2nd ed. Basel: Karger; 2013.CrossRef
32.
Terman JS, Terman M, Lo ES, Cooper TB. Circadian time of morning light administration and therapeutic response in winter depression. Arch Gen Psychiatry Res. 2001;58:69–75.CrossRef
33.
Besier T, Goldbeck L, Keller F. Psychometric properties of the Beck depression inventory-II (BDI-II) among adolescent psychiatric patients. Psychother Psych Med. 2008;58:63–8.CrossRef
34.
35.
Keller F, Grieb J, Ernst M, Sproeber N, Fegert JM, Koelch M. Children’s Depression Rating Scale – Revised (CDRS-R): Development of a German version and psychometric properties in a clinical sample. Z Kinder Jugendpsychiatr Psychothery. 2011;39:179–85.CrossRef
36.
Plener PL, Grieb J, Sprober N, Straub J, Schneider A, Keller F, et al. Convergence of children’s depression rating scale-revised scores and clinical diagnosis in rating adolescent depressive symptomatology. Ment Illn. 2012;4(1):29–31.
37.
March JS, Silva S, Vitiello B, TADS Team. The Treatment for Adolescents with Depression Study (TADS): methods and message at 12 weeks. J Am Acad Child Adolesc Psychiatry. 2006;45:1393–403.CrossRef
38.
Goodyer IM, Dubicka B, Wilkinson P, Kelvin R, Roberts C, Byford S, et al. A randomised controlled trial of cognitive behaviour therapy in adolescents with major depression treated by selective serotonin reuptake inhibitors: The ADAPT trial. Health Technol Assess. 2008;12(14) iii–iv:ix–60.
39.
Görtelmeyer R. Manual zum SF-A/R und SF-B/R - Schlaffragebogen A und B – Revidierte Fassung. Gießen: Hogrefe; 2011.
40.
Tryon WW. The reliability and validity of two ambulatory monitoring actigraphs. Behav Res Methods. 2005;37:492–7.CrossRef
41.
Ravens-Sieberer U, Auquier P, Erhart M, Gosch A, Rajmil L, Bruil J, et al. The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Qual Life Res. 2007;16:1347–56.CrossRef
42.
Starfield B, Riley AW, Green BF, Ensminger ME, Ryan SA, Kelleher K, et al. The adolescent child health and illness profile. A population based measure of health. Med Care. 1995;33:553–66.CrossRef
43.
Forrest CB, Tambor E, Riley AW, Ensminger ME, Starfield B. The health profile of incarcerated male youths. Pediatrics. 1997;105:286–91.
44.
Woerner W, Becker A, Rothenberger A. Normative data and scale properties of the German parent SDQ. Eur Child Adolesc Psychiatry. 2004;13:ii3–ii10.PubMed
45.
Zimmerman P, Fimm B. A test battery for attentional performance. In: Leclercq M, Zimmerman P, editors. Applied Neuropsychology of Attention Theory, Diagnosis and Rehabilitation. London: Psychology Press; 2002. p. 110–51.
46.
Martiny K, Lunde M, Unden M, Dam H, Bech P. High cortisol awakening response is associated with an impairment of the effect of bright light therapy. Acta Psychiatr Scand. 2009;120(3):196–202.CrossRef
47.
Oswald, WD, Roth E. Der Zahlen-Verbindungs-Test (ZVT). Ein sprachfreier Intelligenz-Test zur Messung der “kognitiven Leistungsgeschwindigkeit”. Handanweisung (2.,überarbeitete und erweiterte Auflage). Göttingen: Hogrefe; 1987.
48.
Oswald WD. Zahlen-Verbindungs-Test ZVT. (3., überarbeitete und neu normierte Auflage). Göttingen: Hogrefe; 2016.
49.
Kasper S, Wehr TA, Bartko JJ, Gaist PA, Rosenthal NE. Epidemiological findings of seasonal changes in mood and behavior. A telephone survey of Montgomery County, Maryland, USA. Arch Gen Psychiatry. 1989;46(9):823–33.CrossRef
Metadata
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)
Authors
Martin Holtmann
Laura Mokros
Inken Kirschbaum-Lesch
Michael Kölch
Paul L. Plener
Christian Ruckes
Michael Schulte-Markwort
Tanja Legenbauer
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2949-0

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

Guiding intensive care physicians’ communication and behavior towards bereaved relatives: study protocol for a cluster randomized controlled trial (COSMIC-EOL)

Study protocol

Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial

Study protocol

Effect of laparoscopy by single-port endoscopic access in benign adnexal surgery: study protocol for a randomized controlled trial

Study protocol

Feasibility and acceptability of PrE-operative Physical Activity to improve patient outcomes After major cancer surgery: study protocol for a pilot randomised controlled trial (PEPA Trial)

Study protocol

SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial

Study protocol

Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – Protocol for a randomised clinical feasibility trial