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和昂贵的问题，是使用补充和替代医学（CAM）疗法的主要原因。虽然按摩是最受欢迎的CAM治疗焦虑症的方法之一，但它的有效性从未被诊断为焦虑症进行过严格的评估。这项研究为全面随机临床试验奠定了基础，以评估广泛性焦虑症（GAD）按摩的有效性，安全性和成本，这是一种常见且令人沮丧的疾病，通常会出现许多躯体症状，包括肌肉紧张。在第一阶段，我们会制定和预先测试试验的主要部分，包括参与者的选择标准，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，评估按摩对广泛性焦虑症的有效性和安全性。我们将75名GAD患者随机分为治疗按摩组（n=25）或两个对照组（“热疗”或“放松环境”;每组n=25）。我们将通过比较按摩组和对照组在治疗结束时和6个月时这些结果的变化，评估按摩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。该试点研究将允许我们识别和解决研究设计、结果测量和治疗方案中的意外问题;估计足够动力的全面试验所需的样本量和所需的相关招募期;并获得按摩对GAD的有效性和安全性的初步估计。在这个项目结束时，我们将准备一个有竞争力的赠款提案，以进行全面的试验，评估按摩作为治疗GAD患者的有效性。相关性：虽然美国人通常会因为焦虑和压力而去看按摩治疗师，但没有研究评估按摩作为诊断焦虑症的治疗方法。通过首先开发一系列广泛性焦虑症的按摩疗法，然后在一项试点研究中评估这些疗法，这项研究代表了填补我们知识中这一重要空白的第一步。

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.