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
Jutta S. Mayer,
Katharina Hees,
Juliane Medda,
Oliver Grimm,
Philip Asherson,
Mariano Bellina,
Michael Colla,
Pol Ibáñez,
Elena Koch,
Antonio Martinez-Nicolas,
Adrià Muntaner-Mas,
Anna Rommel,
Nanda Rommelse,
Saskia de Ruiter,
Ulrich W. Ebner-Priemer,
Meinhard Kieser,
Francisco B. Ortega,
Johannes Thome,
Jan K. Buitelaar,
Jonna Kuntsi,
J. Antoni Ramos-Quiroga,
Andreas Reif,
Christine M. Freitag
Affiliations
Jutta S. Mayer
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University
Katharina Hees
Institute of Medical Biometry and Informatics, University Hospital Heidelberg
Juliane Medda
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University
Oliver Grimm
Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Goethe University
Philip Asherson
King’s College London, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience
Mariano Bellina
Department of Psychiatry, Hospital Universitari Vall d’Hebron
Michael Colla
Department of Psychiatry, School of Medicine, University of Rostock
Pol Ibáñez
Psychiatric Genetics Unit, Group of Psychiatry, Mental Health and Addiction, Vall d’Hebron Research Institute (VHIR)
Elena Koch
Mental mHealth Lab, Department of Sport and Sport Science, Karlsruhe Institute of Technology (KIT)
Antonio Martinez-Nicolas
PROFITH “PROmoting FITness and Health through physical activity” research group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada
Adrià Muntaner-Mas
PROFITH “PROmoting FITness and Health through physical activity” research group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada
Anna Rommel
King’s College London, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience
Nanda Rommelse
Department of Psychiatry, Radboudumc
Saskia de Ruiter
Karakter Child and Adolescent Psychiatry University Centre
Ulrich W. Ebner-Priemer
Mental mHealth Lab, Department of Sport and Sport Science, Karlsruhe Institute of Technology (KIT)
Meinhard Kieser
Institute of Medical Biometry and Informatics, University Hospital Heidelberg
Francisco B. Ortega
PROFITH “PROmoting FITness and Health through physical activity” research group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada
Johannes Thome
Department of Psychiatry, School of Medicine, University of Rostock
Jan K. Buitelaar
Karakter Child and Adolescent Psychiatry University Centre
Jonna Kuntsi
King’s College London, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience
J. Antoni Ramos-Quiroga
Department of Psychiatry, Hospital Universitari Vall d’Hebron
Andreas Reif
Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Goethe University
Christine M. Freitag
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University
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.
