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.
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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DOI：
10.1186/s13063-017-2426-1
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发表时间：
2018-02-26
期刊：
影响因子：
2.5
通讯作者：
Freitag CM
中科院分区：
文献类型：
--
作者：
Mayer JS;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 UW;Kieser M;Ortega FB;Thome J;Buitelaar JK;Kuntsi J;Ramos-Quiroga JA;Reif A;Freitag CM
患有注意力缺陷多动障碍（ADHD）的青少年和成人患重度抑郁症和肥胖症的风险增加，青少年ADHD可预测成人抑郁症和肥胖症。迫切需要非药物干预来治疗和预防这些合并症。明亮的光疗法（BLT）改善昼夜节律，是一种新兴的治疗抑郁症的方法。运动干预（EI）可以减少肥胖并改善抑郁症状。迄今为止，尚未进行随机对照试验（RCT）来确定这些干预措施的可行性和有效性，这些干预措施旨在预防ADHD患者的共病抑郁和肥胖。我们假设两种手动干预结合移动的基于健康的监测和强化，与ADHD青少年和年轻人的常规治疗相比，将导致更少的抑郁症状和肥胖。本试验是一项前瞻性、先导性IIa期、平行组RCT，分为3组（2个添加治疗组[BLT、EI]和1个常规治疗组[TAU]对照组）。主要结果变量是基线和干预10周之间抑郁症状量表总分（双盲评估）的变化。使用重复测量方法的混合模型分析该变量，研究所有三组的治疗效果。共有330名年龄在14 - < 30岁的ADHD参与者将在四个研究中心接受筛查。为了确定效应量，计划在α = 0.10（双侧）的自由显著性水平和1-β = 80%的把握度下设计样本量，以发现中等效应。在干预结束后和12周随访时，探讨了次要结局指标，包括肥胖、ADHD症状、一般精神病理学、健康相关生活质量、神经认知功能、时间类型和身体健康的变化。这是第一个关于BLT和EI联合移动的健康监测和强化的试点RCT，旨在预防患有ADHD的青少年和年轻人的共病抑郁和肥胖。如果在预防抑郁症状和肥胖方面至少可以确定中等效果，则可能需要进行更大规模的确证性III期试验。德国临床试验注册中心，DRKS 00011666。于2017年2月9日注册。ClinicalTrials.gov，NCT 03371810。于2017年12月13日注册。本文的在线版本（10.1186/s13063-017-2426-1）包含补充材料，可供授权用户使用。
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. 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. 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. German Clinical Trials Register, DRKS00011666. Registered on 9 February 2017. ClinicalTrials.gov, NCT03371810. Registered on 13 December 2017. The online version of this article (10.1186/s13063-017-2426-1) contains supplementary material, which is available to authorized users.
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