Cited by 48Attention Deficit Hyperactivity DisorderPhysical Activity and HealthSleep and related disorders

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

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Mayer, Jutta S., Hees, Katharina, Medda, Juliane, Grimm, Oliver, Asherson, Philip, Bellina, Mariano, Colla, Michael, Ibáñez, Pol +15 more·2018·Trials

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.

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  • Adolescents with mental or physical diseases such as obesity, chronic fatigue syndrome, attention deficit hyperactivity disorder, may differ from ordinary adolescents in their exercise tolerance.

    “Adolescents with mental or physical diseases such as obesity [81], chronic fatigue syndrome [82], attention deficit hyperactivity disorder [83], may differ from ordinary adolescents in their exercise tolerance.”

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  1. [94]Wechsler D Wechsler intelligence scale for children – Fourth edition (WISC-IV): The Psychological Corporation 2003 San Antonio, TX The Psychological Corporation

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Authors
Mayer, J. S., Hees, K., Medda, J., Grimm, O., Asherson, P., Bellina, M., Colla, M., Ibáñez, P., Koch, E., Martinez-Nicolas, A., Muntaner-Mas, A., Rommel, A., Rommelse, N., de Ruiter, S., Ebner-Priemer, U. W., Kieser, M., Ortega, F. B., Thome, J., Buitelaar, J. K., Kuntsi, J., Ramos-Quiroga, J. A., Reif, A., & Freitag, C. M.
Affiliations
  • Goethe University Frankfurt (DE)
  • University Hospital Heidelberg (DE)
  • King's College London (GB)
  • Vall d'Hebron Institut de Recerca (ES)
  • University of Rostock (DE)
  • Karlsruhe Institute of Technology (DE)
  • Radboud University Nijmegen (NL)
  • Universidad de Granada (ES)
Corresponding author
Mayer, Jutta S.
Venue
Trials
Published
2018-02-26
Volume
19
Issue
1
Pages
140-140
ISSN
1745-6215 (ISSN-L)
OpenAlex
W2794063832
Cited by
48
References
103
Citations by year
2026: 1 · 2025: 11 · 2024: 10 · 2023: 4 · 2022: 6 · 2021: 5 · 2020: 4 · 2019: 5 · 2018: 1 · 2017: 1
FWCI
2.93
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Trials (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Research Portal (King's College London) (publishedVersion, cc-by)
  • heiDOK (Heidelberg University) (acceptedVersion, other-oa)
  • Repository KITopen (Karlsruhe Institute of Technology) (submittedVersion, cc-by)
  • Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, cc-by)
  • Radboud Repository (Radboud University) (submittedVersion)
  • Institutional Repository of the University of Granada (University of Granada) (submittedVersion, cc-by)
  • LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Publication Server of Goethe University Frankfurt am Main (Goethe University Frankfurt) (submittedVersion, cc-by)
  • Radboud Repository (Radboud University) (submittedVersion, other-oa)
  • KITopen (cc-by)
Funders
Horizon 2020 Framework Programme (667302)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Physiology › Physical Activity and Health
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
Keywords
bright light therapy, physical activity, attention deficit hyperactivity disorder, comorbid depression, obesity, adolescents, young adults, mobile health monitoring, chronotype, circadian rhythm, non-pharmacological prevention, depressive symptoms, health-related quality of life, neurocognitive function, physical fitness, general psychopathology, adjunctive therapy, usual care, feasibility and efficacy
MeSH terms
Adolescent, Adult, Affect, Age Factors, Attention Deficit Disorder with Hyperactivity, Depression, Europe, Exercise Therapy, Female, Humans, Male, Phototherapy, Pilot Projects, Prospective Studies, Risk Factors, Time Factors, Multicenter Studies as Topic, Exercise, Comorbidity, Randomized Controlled Trials as Topic, Treatment Outcome, Telemedicine, Clinical Trials, Phase II as Topic, Young Adult, Pediatric Obesity

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