eprintid: 24335
rev_number: 11
eprint_status: archive
userid: 1589
dir: disk0/00/02/43/35
datestamp: 2018-04-30 08:36:20
lastmod: 2021-06-15 20:45:34
status_changed: 2018-04-30 08:36:20
type: article
metadata_visibility: show
creators_name: Mayer, Jutta S.
creators_name: Hees, Katharina
creators_name: Medda, Juliane
creators_name: Grimm, Oliver
creators_name: Asherson, Philip
creators_name: Bellina, Mariano
creators_name: Colla, Michael
creators_name: Ibáñez, Pol
creators_name: Koch, Elena
creators_name: Martinez-Nicolas, Antonio
creators_name: Muntaner-Mas, Adrià
creators_name: Rommel, Anna
creators_name: Rommelse, Nanda
creators_name: Ruiter, Saskia
creators_name: Ebner-Priemer, Ulrich W.
creators_name: Kieser, Meinhard
creators_name: Ortega, Francisco B.
creators_name: Thome, Johannes
creators_name: Buitelaar, Jan K.
creators_name: Kuntsi, Jonna
creators_name: Ramos-Quiroga, J. Antoni
creators_name: Reif, Andreas
creators_name: Freitag, Christine M.
title: 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
subjects: 610
divisions: 911800
abstract: 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.
date: 2018
publisher: BioMed Central
id_scheme: DOI
ppn_swb: 1656276798
own_urn: urn:nbn:de:bsz:16-heidok-243357
language: eng
bibsort: MAYERJUTTABRIGHTLIGH2018
full_text_status: public
publication: Trials
volume: 19
number: 140
place_of_pub: London
pagerange: 1-19
issn: 1468-6694
citation:   Mayer, Jutta S. ; Hees, Katharina ; Medda, Juliane ; Grimm, Oliver ; Asherson, Philip ; Bellina, Mariano ; Colla, Michael ; Ibáñez, Pol ; Koch, Elena ; Martinez-Nicolas, Antonio ; Muntaner-Mas, Adrià ; Rommel, Anna ; Rommelse, Nanda ; Ruiter, Saskia ; Ebner-Priemer, Ulrich W. ; Kieser, Meinhard ; Ortega, Francisco B. ; Thome, Johannes ; Buitelaar, Jan K. ; Kuntsi, Jonna ; Ramos-Quiroga, J. Antoni ; Reif, Andreas ; Freitag, Christine M.  (2018) 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.  Trials, 19 (140).  pp. 1-19.  ISSN 1468-6694     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/24335/1/13063_2017_Article_2426.pdf