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世界各地的一个主要公共卫生问题。青春期的重度抑郁症（MDD）很常见，点患病率为3%至9%。在美国，据估计，到17岁时，14%的青少年将经历至少一次严重抑郁症发作。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缓解，残留症状与高复发率相关。在大多数研究中，阳性反应定义为症状改善30-50%和/或受试者总体评分改善很多或非常多。在成年人中，运动被用作单一治疗和抗抑郁药物的增强治疗。我们最近完成的成人运动治疗随机试验发现，在那些随机接受公共健康运动剂量的患者中，反应率和缓解率分别为46%和42%。在青少年中，使用运动治疗MDD的数据相对较少。2006年，科克伦（Cochrane）对运动预防和治疗青少年抑郁症的研究进行了综述，发现支持运动的效应量很小，但这一结论是基于少量方法学质量较低的随机临床试验的证据。在本探索性R34中，本申请的具体目标是：1）制定详细的程序手册（MOP），以进行运动治疗青少年抑郁症的急性期随机试验; 2）从各种招募策略的测试中估计招募率;以及，3）在（n=40）被诊断患有抑郁症的青少年中进行先导性试验，以确定治疗效果大小、依从性和脱落率的估计值。为了实现这些目标，该项目分为三个阶段。第一阶段将是制定MOP的第一份草案，该草案将适应从先前的试验中开发的程序，该试验检查了两种剂量的运动治疗成人MDD。第二阶段将测试具体的征聘方法，以确定每项战略的征聘效果，并将对第一阶段制定的筛选程序进行试点测试。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症的基线和结果措施;制定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、依从性和脱落率的估计值。这些数据将使我们能够指定所有必要的研究程序，以满足未来的高方法质量的标准，更大规模的，对照研究运动在抑郁的青年，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R 01应用的样本量。这项初步研究可能会产生重要的研究结果，如何适应运动治疗青少年抑郁症。这项研究的潜在公共卫生益处包括减少青少年抑郁症和与年轻人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，由于这项研究规定体育活动作为抑郁症的治疗方法，因此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.