Adapting Exercise Treatment for Depression to Adolescents: A Pilot Study

描述(由申请者提供)：青少年抑郁症是美国和全世界的一个主要公共卫生问题。严重抑郁障碍(MDD)在青春期很常见，时点患病率为3%至9%。在美国，据估计，到17岁时，14%的青少年将至少经历过一次严重的抑郁障碍。尽管在过去的10-15年里，关于药物疗效的研究急剧增加，主要是选择性5-羟色胺再摄取抑制剂(SSRIs)和认知行为疗法(CBT)，但青少年抑郁症的有效治疗显然是必要的。药物和CBT很少导致症状的完全和持久的缓解，残留的症状与高复发率相关。在大多数研究中，积极反应被定义为症状改善30%-50%和/或对象有很大或非常大改善的全球评级。在成年人中，运动一直被用作单一疗法，也被用作抗抑郁药物的强化疗法。我们最近完成的成人运动治疗随机试验发现，在随机接受公共健康剂量的运动治疗的人中，有效率和缓解率分别为46%和42%。在青少年中，使用运动治疗MDD的数据相对较少。2006年，Cochrane对运动预防和治疗青少年抑郁症的综述发现，支持运动的效果很小，但这一结论是基于少数方法学质量较低的随机临床试验的证据。在这一探索性R34中，本应用程序的具体目标是：1)制定详细的程序手册(MOP)，以进行治疗青少年抑郁症的急性阶段随机试验；2)从各种招募策略的测试中估计招募收益；以及，3)在(n=40)被诊断为抑郁症的青少年中进行试行试验方法，以确定治疗效果大小、依从性和辍学率的估计。为了实现这些目标，该项目被组织为3个阶段。第一阶段将是开发第一个MOP草案，该草案将调整从先前审查两剂运动治疗成人MDD的试验中制定的程序。第二阶段将测试具体的招募方法，以确定每项战略的招募收益，并将试点第一阶段制定的测试筛查程序。第三阶段将是干预措施的试点测试，将包括制定运动和抑郁的基线和结果衡量标准；开发和实施实验性运动治疗；以及确定运动对抑郁症状的影响。在初步研究后，我们将敲定《行动纲领》的所有程序，并估计效果大小、遵守情况和辍学率。这些数据将使我们能够明确所有必要的研究程序，以满足未来对抑郁青年进行更大规模的受控运动研究的高方法学质量标准，并将为我们提供必要的经验。此外，试点研究的结果将使我们能够为未来的R01应用更准确地量化样本大小。这项先导研究可能会在如何适应青少年抑郁症的运动治疗方面产生重要的研究成果。这项研究的潜在公共健康益处包括减少青少年抑郁症和与年轻人中未经治疗的抑郁症相关的问题，包括自杀、药物滥用、吸烟、青少年怀孕、心理社会功能受损和学业失败。此外，由于这项研究将体育锻炼作为治疗抑郁症的一种方法，额外的公共健康益处可能包括减少肥胖、糖尿病和心脏病等慢性疾病，所有这些疾病都与久坐行为有关。

DESCRIPTION (provided by applicant): Adolescent depression is a major public health problem in the United States and throughout the world. Major depressive disorder (MDD) in adolescence is common with point prevalence rates of 3% to 9%. In the U.S., it is estimated that by the time adolescents reach the age of 17, 14% will have experienced at least one episode of major depressive disorder. Effective treatments of adolescent depression are clearly needed despite the fact that in the past 10-15 years, there has been a dramatic increase in studies of the efficacy of medications, primarily the selective serotonin reuptake inhibitors (SSRIs) and of cognitive behavioral therapy (CBT). Medications and CBT rarely result in complete and lasting remission of symptoms, and residual symptoms are associated with a high rate of relapse. In most studies, a positive response is defined as a 30-50% improvement in symptoms and/or a global rating that the subject is much or very much improved. In adults, exercise has been used as a mono-therapy and as an augmentation therapy with antidepressant medication. Our recently completed randomized trial of exercise treatment in adults found response and remission rates of 46% and 42%, in those randomized to a public health dose of exercise. In adolescents, data on the use of exercise to treat MDD is relatively sparse. A 2006 Cochrane review of exercise to prevent and treat depression in adolescents found a small effect size in support of exercise, but the conclusion is based on evidence from a small number of randomized clinical trials of low methodological quality. In this exploratory R34, the specific aims of this application are to: 1) Develop a detailed Manual of Procedures (MOP) to conduct an acute-phase randomized trial of exercise to treat adolescent depression; 2) Develop estimates of recruitment yield from tests of various recruitment strategies; and, 3) Pilot test trial methodologies in (n=40) adolescents diagnosed with depression to ascertain estimates of treatment effect sizes, adherence and drop-out rates. To achieve these aims, the project is organized into 3 phases. Phase I will be the development of the first draft MOP that will adapt procedures developed from a previous trial examining two doses of exercise in treatment of adult MDD. Phase II will test specific recruitment methodologies to determine recruitment yields for each strategy and will pilot test screening procedures developed in Phase I. Phase III will be a pilot test of the intervention and will include development of baseline and outcome measures of exercise and depression; development and implementation of the experimental exercise treatment; and determination of the effects of exercise on depressive symptoms. Following the pilot study, we will finalize all procedures for the MOP and obtain estimates of effect sizes, adherence and drop out rates. These data will allow us to specify all study procedures necessary to meet standards of high methodological quality for a future, larger-scale, controlled study of exercise in depressed youth and will provide us with needed experience. Additionally, the results of the pilot study will enable us to more precisely quantify sample sizes for a future R01 application. This pilot study may yield important research findings on how to adapt exercise treatment for depression among adolescents. Potential public health benefits from this study include a reduction of adolescent depression and problems associated with untreated depression in young adults including suicide, substance abuse, cigarette smoking, teen pregnancy, impaired psychosocial functioning and school failure. In addition, because this study prescribes physical activity as a treatment for depression, additional public health benefits may include a reduction in chronic diseases such as obesity, diabetes and heart disease, all of which are associated with sedentary behavior.