Therapeutic Massage for Generalized Anxiety Disorder

描述(由申请人提供)：焦虑和压力是困扰美国成年人的常见且代价高昂的问题，也是使用补充和替代医学(CAM)疗法的主要原因。尽管按摩是治疗焦虑症最受欢迎的CAM疗法之一，但它的有效性从未被严格评估过。这项研究为评估按摩治疗广泛性焦虑症(GAD)的有效性、安全性和成本的全面随机临床试验奠定了基础。广泛性焦虑症是一种常见的令人沮丧的疾病，通常会出现许多躯体症状，包括肌肉紧张。在这个项目的第一阶段，我们将开发和预先测试此类试验的关键部分，包括参与者选择标准以及按摩组和对照组的治疗方案。在第二阶段，我们将使用第一阶段开发的组件进行试点试验，评估按摩治疗广泛性焦虑症的有效性和安全性。我们将75名广泛性焦虑症患者随机分为治疗推拿组(n=25)或两个对照组(“热疗”或“放松环境”，n=25)。我们将通过比较推拿组和对照组在治疗结束和6个月时这些结果的变化来评估推拿对焦虑相关症状和功能障碍、生活质量和GAD相关提供者就诊费用的影响。试点研究将使我们能够识别和解决研究设计、结果测量和治疗方案方面的意想不到的问题；估计充分动力的全面试验所需的样本量和所需的相关招募时间；以及对按摩治疗广泛性AD的有效性和安全性进行初步估计。在这个项目结束时，我们将准备一份竞争性的赠款提案，以进行一项全面的试验，评估按摩作为治疗广泛性焦虑症的疗效。相关性：尽管美国人通常会因焦虑和压力去看按摩治疗师，但还没有研究评估按摩是治疗确诊的焦虑症的一种方法。这项研究首先开发了一系列治疗广泛性焦虑症的按摩疗法，然后在一项试点研究中对这些疗法进行了评估，这项研究代表着朝着填补我们知识上的这一重要空白迈出的第一步。

DESCRIPTION (provided by applicant): Anxiety and stress are common and costly problems afflicting American adults and are a leading reason for using complementary and alternative medical (CAM) therapies. Although massage is one of the most popular CAM treatments for anxiety, its effectiveness has never been rigorously evaluated for a diagnosed anxiety disorder. This study lays the groundwork for a full-scale randomized clinical trial to evaluate the effectiveness, safety, and costs of massage for generalized anxiety disorder (GAD), a common and frustrating condition that often presents with many somatic symptoms, including muscle tension. In Phase I of this project, we will develop and pre-test key components of such a trial, including participant selection criteria and the treatment protocols for the massage and comparison groups. In Phase II, we will use the components developed during Phase I to conduct a pilot trial evaluating the effectiveness and safety of massage for GAD. We will randomize 75 persons with GAD to therapeutic massage (n=25) or to one of two control groups ("thermotherapy" or a "relaxing environment"; n=25 for each). We will evaluate the effect of massage on anxiety-related symptoms and dysfunction, quality of life, and costs of GAD-related provider visits by comparing changes in these outcomes in the massage and control groups at the end of treatment and at 6 months. The pilot study will permit us to identify and address unanticipated problems with the study design, outcome measures, and treatment protocols; to estimate the samples sizes needed for an adequately-powered full-scale trial and the related recruitment period that would be required; and to obtain preliminary estimates of the effectiveness and safety of massage for GAD. At the conclusion of this project, we will be well positioned to prepare a competitive grant proposal for a full-scale trial evaluating the effectiveness of massage as a treatment for persons with GAD. RELEVANCE: Although Americans commonly visit massage therapists for anxiety and stress , no studies have evaluated massage as a treatment for a diagnosed anxiety disorder. By first developing a series of massage treatments for generalized anxiety disorder and then evaluating these treatments in a pilot study, this study represents the first step toward filling this important gap in our knowledge.