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

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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.

Electronic supplementary material

The online version of this article (10.1186/s13063-018-2949-0) contains supplementary material, which is available to authorized users.

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Most cited references 47

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The size and burden of mental disorders and other disorders of the brain in Europe 2010.

H.U. Wittchen, F. Jacobi, J. Rehm … (2011)

To provide 12-month prevalence and disability burden estimates of a broad range of mental and neurological disorders in the European Union (EU) and to compare these findings to previous estimates. Referring to our previous 2005 review, improved up-to-date data for the enlarged EU on a broader range of disorders than previously covered are needed for basic, clinical and public health research and policy decisions and to inform about the estimated number of persons affected in the EU. Stepwise multi-method approach, consisting of systematic literature reviews, reanalyses of existing data sets, national surveys and expert consultations. Studies and data from all member states of the European Union (EU-27) plus Switzerland, Iceland and Norway were included. Supplementary information about neurological disorders is provided, although methodological constraints prohibited the derivation of overall prevalence estimates for mental and neurological disorders. Disease burden was measured by disability adjusted life years (DALY). Prevalence: It is estimated that each year 38.2% of the EU population suffers from a mental disorder. Adjusted for age and comorbidity, this corresponds to 164.8million persons affected. Compared to 2005 (27.4%) this higher estimate is entirely due to the inclusion of 14 new disorders also covering childhood/adolescence as well as the elderly. The estimated higher number of persons affected (2011: 165m vs. 2005: 82m) is due to coverage of childhood and old age populations, new disorders and of new EU membership states. The most frequent disorders are anxiety disorders (14.0%), insomnia (7.0%), major depression (6.9%), somatoform (6.3%), alcohol and drug dependence (>4%), ADHD (5%) in the young, and dementia (1-30%, depending on age). Except for substance use disorders and mental retardation, there were no substantial cultural or country variations. Although many sources, including national health insurance programs, reveal increases in sick leave, early retirement and treatment rates due to mental disorders, rates in the community have not increased with a few exceptions (i.e. dementia). There were also no consistent indications of improvements with regard to low treatment rates, delayed treatment provision and grossly inadequate treatment. Disability: Disorders of the brain and mental disorders in particular, contribute 26.6% of the total all cause burden, thus a greater proportion as compared to other regions of the world. The rank order of the most disabling diseases differs markedly by gender and age group; overall, the four most disabling single conditions were: depression, dementias, alcohol use disorders and stroke. In every year over a third of the total EU population suffers from mental disorders. The true size of "disorders of the brain" including neurological disorders is even considerably larger. Disorders of the brain are the largest contributor to the all cause morbidity burden as measured by DALY in the EU. No indications for increasing overall rates of mental disorders were found nor of improved care and treatment since 2005; less than one third of all cases receive any treatment, suggesting a considerable level of unmet needs. We conclude that the true size and burden of disorders of the brain in the EU was significantly underestimated in the past. Concerted priority action is needed at all levels, including substantially increased funding for basic, clinical and public health research in order to identify better strategies for improved prevention and treatment for disorders of the brain as the core health challenge of the 21st century. Copyright © 2011. Published by Elsevier B.V.

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The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries.

Ulrike Ravens-Sieberer, Pascal Auquier, Michael Erhart … (2007)

To assess the construct and criterion validity of the KIDSCREEN-27 health-related quality of life (HRQoL) questionnaire, a shorter version of the KIDSCREEN-52. The five-dimensional KIDSCREEN-27 was tested in a sample of 22,827. For criterion validity the correlation with and the percentage explained variance of the scores of the KIDSCREEN-52 instrument were examined. Construct validity was assessed by testing a priori expected associations with other generic HRQoL measures (YQOL-S, PedsQL, CHIP), indicators of physical and mental health, and socioeconomic status. Age and gender differences were investigated. Correlation with corresponding scales of the KIDSCREEN-52 ranged from r = 0.63 to r = 0.96, and r2 ranged from 0.39 to 0.92. Correlations between other HRQoL questionnaires and KIDSCREEN-27 dimensions were moderate to high for those assessing similar constructs (r = 0.36 to 0.63). Statistically significant and sizeable differences between physically and mentally healthy and ill children were found in all KIDSCREEN-27 dimensions together with strong associations with psychosomatic complaints (r = -0.52). Most of the KIDSCREEN-27 dimensions showed a gradient according to socio-economic status, age and gender. The KIDSCREEN-27 seems to be a valid measure of HRQoL in children and adolescents. Further research is needed to assess longitudinal validity and sensitivity to change.

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Normative data and scale properties of the German parent SDQ.

Wolfgang Woerner, Andreas Becker, Aribert Rothenberger (2004)

The Strengths and Difficulties Questionnaire (SDQ) is a short assessment instrument which addresses positive and negative behavioural attributes of children and adolescents and generates scores for clinically relevant aspects. Although this brief questionnaire has been widely used in Germany to gather information from parents, teachers, and older children themselves, normative results obtained with the German version have not yet been reported to the international scientific community. To allow comparisons with SDQ findings in other countries, normative data for the German parent-rated form as well as a community-based evaluation of scale properties are summarised and complemented by results obtained in a number of clinical samples. Parent ratings were collected for a community-based sample of 930 children and adolescents aged between 6 and 16 years, in which both genders and all age levels were equally represented. Statistical evaluation of psychometric properties included a factor analysis verifying the proposed scale structure, assessment of scale homogeneities, and determination of age, gender and social class effects. Based on the distributions of SDQ scores observed in this normative sample, recommended bandings identifying normal, borderline, and clinical ranges were defined for each scale. Exact replication of the original scale structure, satisfactory internal reliabilities, and observation of the expected associations with age and gender confirmed the equivalence of the German SDQ parent questionnaire with the English original. Differences between community-based results and clinical groups provided descriptive evidence of a dramatic impact of clinically defined psychiatric status on SDQ scores. After evaluating parent ratings obtained in a community-based sample, the German SDQ was shown to possess favourable psychometric properties. Thus, the German translation of this popular and versatile instrument seems to be a similarly reliable and useful assessment tool as the original English questionnaire.

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Author and article information

Contributors

Martin Holtmann: +49 23818931069 , martin.holtmann@lwl.org

Laura Mokros: Laura_Dr.Mokros@lwl.org

Inken Kirschbaum-Lesch: inken.kirschbaum@rub.de

Michael Kölch: M.Koelch@ruppiner-kliniken.de

Paul L. Plener: paul.plener@uniklinik-ulm.de

Christian Ruckes: ruckes@izks-mainz.de

Michael Schulte-Markwort: schulte-markwort@uke.de

Tanja Legenbauer: tanja.legenbauer@rub.de

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 19 October 2018

Publication date PMC-release: 19 October 2018

Publication date Collection: 2018

Volume: 19

Electronic Location Identifier: 568

Affiliations

[1 ]Clinic for Child and Adolescent Psychiatry, LWL University Hospital Hamm of the Ruhr-University Bochum, Heithofer Allee 64, 59071 Hamm, Germany

[2 ]Department Child and Adolescent Psychiatry and Psychotherapy, Brandenburg Medical School, Neuruppin, Germany

[3 ]ISNI 0000 0004 1936 9748, GRID grid.6582.9, Department of Child and Adolescent Psychiatry and Psychotherapy, , Ulm University, ; Ulm, Germany

[4 ]ISNI 0000 0001 1941 7111, GRID grid.5802.f, Interdisciplinary Centre for Clinical Trials, Mainz University, ; Mainz, Germany

[5 ]ISNI 0000 0001 2287 2617, GRID grid.9026.d, Department Child and Adolescent Psychiatry, , Hamburg University, ; Hamburg, Germany

Article

Publisher ID: 2949

DOI: 10.1186/s13063-018-2949-0

PMC ID: 6194631

PubMed ID: 30340625

SO-VID: 4d151506-df8c-43a7-bc22-39186850bc5c

License:

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.

History

Date received : 30 November 2017

Date accepted : 28 September 2018

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100002347, Bundesministerium für Bildung und Forschung;

Award ID: 01KG1713

Award Recipient : Martin Holtmann

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: depression in youth,treatment,bright light therapy,inpatients

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ScienceOpen disciplines: Medicine

Keywords: depression in youth, treatment, bright light therapy, inpatients

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

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Abstract

Background

Methods/design

Discussion

Trial registration

Electronic supplementary material

Related collections

Network Medicine

Most cited references 47

The size and burden of mental disorders and other disorders of the brain in Europe 2010.

The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries.

Normative data and scale properties of the German parent SDQ.

Author and article information

Contributors

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Comment on this article

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Cited by 5

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