Adapting Exercise Treatment for Depression to Adolescents: A Pilot Study

描述（由申请人提供）：青少年抑郁症是美国和全世界的一个主要公共卫生问题。青春期重度抑郁症（MDD）很常见，点患病率为3%至9%。在美国，据估计，当青少年达到17岁时，14%的人将经历至少一次重度抑郁症发作。青少年抑郁症的有效治疗显然是需要的，尽管在过去的10-15年里，对药物疗效的研究急剧增加，主要是选择性血清素再摄取抑制剂（SSRIs）和认知行为疗法（CBT）。药物治疗和CBT很少导致症状的完全和持久缓解，残留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/或受试者整体改善或非常改善的评分。在成年人中，运动被用作单一疗法，也被用作抗抑郁药物的辅助疗法。我们最近完成的成人运动治疗的随机试验发现，在随机分配到公共健康剂量的运动中，反应率和缓解率分别为46%和42%。在青少年中，使用运动治疗重度抑郁症的数据相对较少。2006年Cochrane的一篇关于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，但该结论是基于少量随机临床试验的证据，这些试验的方法学质量很低。在这个探索性的R34中，这个应用程序的具体目的是：1)制定一个详细的程序手册（MOP）来进行运动治疗青少年抑郁症的急性期随机试验；2)通过对各种招聘策略的测试，估算招聘收益；3)在（n=40）被诊断为抑郁症的青少年中进行试点试验，以确定治疗效果大小、依从性和退出率的估计。为了实现这些目标，该项目分为三个阶段。第一阶段将是开发第一份MOP草案，该草案将采用先前研究成人重度抑郁症治疗中两种剂量运动的试验开发的程序。第二阶段将测试特定的招募方法，以确定每种策略的招募效果，并将试点测试第一阶段开发的筛选程序。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测量；实验性运动疗法的开发与实施；以及确定运动对抑郁症状的影响。在试点研究之后，我们将完成MOP的所有程序，并获得效应量、依从性和退出率的估计。这些数据将使我们能够指定所有必要的研究程序，以满足未来更大规模的抑郁症青年运动控制研究的高方法学质量标准，并将为我们提供所需的经验。此外，试点研究的结果将使我们能够更精确地量化未来R01应用的样本量。这项初步研究可能会对如何适应青少年抑郁症的运动治疗产生重要的研究结果。这项研究的潜在公共卫生效益包括减少青少年抑郁症和与未治疗的年轻人抑郁症相关的问题，包括自杀、药物滥用、吸烟、少女怀孕、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抑郁症的一种治疗方法，额外的公共健康益处可能包括减少慢性疾病，如肥胖、糖尿病和心脏病，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.