TY  - JOUR
A1  - Mayer, Jutta
A1  - Hees, Katharina
A1  - Medda, Juliane
A1  - Grimm, Oliver
A1  - Asherson, Philip
A1  - Bellina, Mariano
A1  - Colla, Michael
A1  - Ibáñez, Pol
A1  - Koch, Elena
A1  - Martinez-Nicolas, Antonio
A1  - Muntaner-Mas, Adrià
A1  - Rommel, Anna-Sophie
A1  - Rommelse, Nanda
A1  - Ruiter, Saskia de
A1  - Ebner-Priemer, Ulrich
A1  - Kieser, Meinhard
A1  - Ortega, Francisco B.
A1  - Thome, Johannes
A1  - Buitelaar, Jan K.
A1  - Kuntsi, Jonna
A1  - Ramos-Quiroga, J. Antoni
A1  - Reif, Andreas
A1  - Freitag, Christine M.
T1  - 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
T2  - Trials
N2  - Background: 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.
Methods: 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.
Discussion: 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.
Trial registration: German Clinical Trials Register, DRKS00011666. Registered on 9 February 2017. ClinicalTrials.gov, NCT03371810. Registered on 13 December 2017.
KW  - Attention-deficit / hyperactivity disorder
KW  - Co-morbidity
KW  - Depression
KW  - Obesity
KW  - Bright light therapy
KW  - Exercise
Y1  - 2018
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/46385
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-463852
SN  - 1468-6694
SN  - 1745-6215
SN  - 1468-6708
N1  - © The Author(s). 2018 Open Access This 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.
VL  - 19
IS  - 1, Art. 140
SP  - 1
EP  - 19
PB  - BioMed Central
CY  - London
ER  -