Bright light therapy versus physical exercise to prevent co-morbid depression and obesity in adolescents and young adults with attention-deficit / hyperactivity disorder : study protocol for a randomized controlled trial
Mayer, Jutta S.
Hees, Katharina (Heidelberg, Germany)
Medda, Juliane (Deutschordenstr. 50, 60528 Frankfurt am Main, Germany)
Grimm, Oliver (Frankfurt am Main, Germany)
Asherson, Philip (London, UK)
Bellina, Mariano (Hospital Universitari Vall d'Hebron)
Colla, Michael (Rostock, Germany)
Ibáñez, Pol (Hospital Universitari Vall d'Hebron)
Koch, Elena (Karlsruhe, Germany)
Martinez-Nicolas, Antonio (Madrid, Spain)
Muntaner-Mas, Adrià (Palma, Spain)
Rommel, Anna-Sophie (London, UK)
Rommelse, Nanda (Nijmegen, The Netherlands)
de Ruiter, Saskia (Radboudumc, Nijmegen, The Netherlands)
Ebner-Priemer, Ulrich W. (Karlsruhe, Germany)
Kieser, Meinhard (Heidelberg, Germany)
Ortega, Francisco B. (Granada, Spain)
Thome, Johannes (Rostock, Germany)
Buitelaar, Jan (Radboudumc, Nijmegen, The Netherlands)
Kuntsi, Jonna (London, UK)
Ramos-Quiroga, Josep Antoni (Universitat Autònoma de Barcelona. Departament de Psiquiatria i de Medicina Legal)
Reif, Andreas (Frankfurt am Main, Germany)
Freitag, Christine M. (Deutschordenstr. 50, 60528 Frankfurt am Main, Germany)

Date:	2018
Abstract:	The risk for major depression and obesity is increased in adolescents and adults with attention-deficit / hyperactivity disorder (ADHD) and adolescent ADHD predicts adult depression and obesity. Non-pharmacological interventions to treat and prevent these co-morbidities are urgently needed. Bright light therapy (BLT) improves day-night rhythm and is an emerging therapy for major depression. Exercise intervention (EI) reduces obesity and improves depressive symptoms. To date, no randomized controlled trial (RCT) has been performed to establish feasibility and efficacy of these interventions targeting the prevention of co-morbid depression and obesity in ADHD. We hypothesize that the two manualized interventions in combination with mobile health-based monitoring and reinforcement will result in less depressive symptoms and obesity compared to treatment as usual in adolescents and young adults with ADHD. This trial is a prospective, pilot phase-IIa, parallel-group RCT with three arms (two add-on treatment groups [BLT, EI] and one treatment as usual [TAU] control group). The primary outcome variable is change in the Inventory of Depressive Symptomatology total score (observer-blinded assessment) between baseline and ten weeks of intervention. This variable is analyzed with a mixed model for repeated measures approach investigating the treatment effect with respect to all three groups. A total of 330 participants with ADHD, aged 14 - < 30 years, will be screened at the four study centers. To establish effect sizes, the sample size was planned at the liberal significance level of α = 0. 10 (two-sided) and the power of 1-β = 80% in order to find medium effects. Secondary outcomes measures including change in obesity, ADHD symptoms, general psychopathology, health-related quality of life, neurocognitive function, chronotype, and physical fitness are explored after the end of the intervention and at the 12-week follow-up. This is the first pilot RCT on the use of BLT and EI in combination with mobile health-based monitoring and reinforcement targeting the prevention of co-morbid depression and obesity in adolescents and young adults with ADHD. If at least medium effects can be established with regard to the prevention of depressive symptoms and obesity, a larger scale confirmatory phase-III trial may be warranted. German Clinical Trials Register, DRKS00011666. Registered on 9 February 2017. ClinicalTrials. gov, NCT03371810. Registered on 13 December 2017. The online version of this article (10. 1186/s13063-017-2426-1) contains supplementary material, which is available to authorized users.
Grants:	Ministerio de Economía y Competitividad RYC-2011-09011
Note:	Altres ajuts: The trial is funded by the EU Framework Programme for Research and Innovation, Horizon 2020 (Project no. 667302). Funding period: January 2016-December 2020. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. Some local funds additionally contributed to carry out this study, especially for the preparation of the interventions: by the University of Granada, Plan Propio de Investigación 2016, Excellence actions: Unit of Excellence on Exercise and Health (UCEES).
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Attention-deficit / hyperactivity disorder ; Co-morbidity ; Depression ; Bright light therapy ; Exercise ; Obesity
Published in:	Trials, Vol. 19 (february 2018) , ISSN 1745-6215

DOI: 10.1186/s13063-017-2426-1
PMID: 29482662

19 p, 1.2 MB

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