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

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.

Keywords: Attention-deficit / hyperactivity disorder; Bright light therapy; Co-morbidity; Depression; Exercise; Obesity.

Conflict of interest statement

Authors’ information

Not applicable.

Ethics approval and consent to participate

The study protocol was first ethically reviewed and approved by the institutional review board of the Medical Faculty, Goethe University, Frankfurt am Main, German (No. 353/16, 13 January 2017). Subsequent approval of this vote was done by the ethical committee of Vall d’Hebron Research Institute, Barcelona, Spain (No. PR(AG)105/2017, 19 April 2017), King’s College London, UK (No. 17/LO/0958, 11 July 2017), and Radboud University Medical Centre, Nijmegen, The Netherlands (No. 2017-3238, 05 October 2017). The Informed Consent Form will be provided by the investigator before the participants’ inclusion in the study.

Consent for publication

Not applicable.

Competing interests

AR has received grant support and speaker’s honoraria from Medice and Servier.

CMF receives royalties for books on ADHD and ASD. She has served as consultant for Desitin and Roche with regard to ASD.

JARQ was on the speakers’ bureau and/or acted as consultant for Eli-Lilly, Janssen-Cilag, Novartis, Shire, Lundbeck, Almirall, B-Gaze, and Rubió in the last three years. He also received travel awards (air tickets and hotel) for taking part in psychiatric meetings from Janssen-Cilag, Rubió, Shire, and Eli- Lilly. The ADHD Program chaired by him received unrestricted educational and research support from the following pharmaceutical companies in the last three years: Eli-Lilly, Lundbeck, Janssen- Cilag, Actelion, Shire, and Rubió.

JKB has been in the past three years a consultant to / member of advisory board of / and/or speaker for Janssen Cilag BV, Eli Lilly, Lundbeck, Shire, Roche, Medice, Novartis, and Servier. He has received research support from Roche and Vifor. He is not an employee of any of these companies and is not a stock shareholder of any of these companies. He has no other financial or material support, including expert testimony, patents, royalties.

MB received travel awards (air tickets and hotel) for taking part in psychiatric meetings from Janssen-Cilag and Shire in the last three years.

PA has received funding for research by Vifor Pharma and has given sponsored talks and been an advisor for Shire, Janssen–Cilag, Eli-Lilly, Flynn Pharma, and Pfizer, regarding the diagnosis and treatment of ADHD. All funds are received by King’s College London and used for studies of ADHD.

The remaining authors do not report any conflicts of interest.

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Figures

Fig. 1

M-Health system consisting of the smartphone and the sensor (adapted with permission of movisens). Example from the EI intervention. The “home screen” of the movisensXS app shows four different buttons: (1) Goal of the week; (2) Learn about the exercises; (3) Start exercise; (4) Feedback. If participants press button three (Start exercise), the exercise videos are played

Fig. 2

Trial time flow. T, time-point; I, intervention; EI, exercise intervention; BLT, bright light therapy; TAU, treatment as usual

Fig. 3

Schedule of enrolment, interventions, and assessments at the different time-points (T1–T5)