CBT Augmentation of Paroxetine for Social Anxiety

CBT 增强帕罗西汀治疗社交焦虑

• 批准号: 6687013
• 负责人: RICHARD G HEIMBERG
• 金额: $ 30.48万
• 依托单位: TEMPLE UNIV OF THE COMMONWEALTH
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-15 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6687013
• 关键词: behavior prediction; behavioral /social science research tag; clinical anxiety; clinical research; cognitive behavior therapy; combination therapy; fear; functional ability; human subject; human therapy evaluation; mental disorder chemotherapy; neuropharmacology; paroxetine; patient oriented research; psychological tests; quality of life; relapse /recurrence; sign /symptom; social psychology

DESCRIPTION (provided by applicant): Social anxiety disorder is a prevalent, chronic and disabling condition. Paroxetine has received FDA approval on the basis of its acute efficacy for this disorder, but much about longer-term management remains uncertain. There are virtually no data regarding next steps in treatment despite evidence that most patients who receive acute paroxetine therapy still exhibit significant residual symptoms. Furthermore, there are also no data regarding methods for minimizing relapse when medication is discontinued despite evidence that relapse rates in such circumstances are high. Cognitive-behavioral therapy (CBT) is a good candidate for augmenting paroxetine response and reducing relapse after medication discontinuation as it has been shown to be an effective treatment in its own right and often associated with lesser relapse than medication alone. Although CBT has been found to be useful in these circumstances for depression and panic disorder, there have been no similar studies in social anxiety disorder. This application will examine the ability of CBT to augment acute paroxetine response and reduce relapse following paroxetine discontinuation in social anxiety disorder. It will also examine the degree of residual symptoms and disability as well as rates of remission and improvements in quality of life in response to paroxetine alone or with the addition of CBT. Predictors of acute response and relapse after treatment is discontinued will also be explored. To achieve these ends, two hundred fifty patients will receive 12 weeks of open treatment with paroxetine. Patients showing at least some benefit will be randomized to continued paroxetine with or without CBT for 16 additional weeks. All treatment will then be tapered and patients will be followed for 24 additional weeks. Overall, this study should provide important information about the augmentation of paroxetine treatment for patients with social anxiety disorder, effective methods for reducing relapse, and who may benefit from paroxetine treatment or relapse when medication is withdrawn. It will also increase understanding of the interplay of psychosocial and pharmacological treatment methods and psychological and biological factors in patients' total response to treatment.

描述（由申请人提供）：社交焦虑症是一种普遍的、慢性的、致残的疾病。帕罗西汀因其对这种疾病的急性疗效而获得 FDA 批准，但长期治疗仍有很多不确定性。尽管有证据表明大多数接受急性帕罗西汀治疗的患者仍然表现出明显的残留症状，但实际上没有关于后续治疗步骤的数据。此外，也没有关于在停药时最大限度地减少复发的方法的数据，尽管有证据表明这种情况下的复发率很高。认知行为疗法（CBT）是增强帕罗西汀反应和减少停药后复发的良好候选者，因为它已被证明本身就是一种有效的治疗方法，并且通常比单独药物治疗更少复发。尽管 CBT 被发现在这些情况下对治疗抑郁症和恐慌症有用，但在社交焦虑症方面还没有类似的研究。该应用将检查 CBT 增强帕罗西汀急性反应并减少社交焦虑症停药后复发的能力。它还将检查残余症状和残疾的程度，以及单独使用帕罗西汀或联合 CBT 的缓解率和生活质量的改善。还将探讨治疗停止后急性反应和复发的预测因素。为了实现这些目标，250 名患者将接受为期 12 周的帕罗西汀开放治疗。表现出至少一些获益的患者将被随机分配继续服用帕罗西汀，联合或不联合 CBT 治疗 16 周。然后，所有治疗将逐渐减少，并对患者进行另外 24 周的随访。总体而言，这项研究应提供有关社交焦虑障碍患者加强帕罗西汀治疗、减少复发的有效方法以及哪些人可能受益于帕罗西汀治疗或停药后复发的重要信息。它还将增加对心理社会和药物治疗方法以及心理和生物因素在患者对治疗的总体反应中相互作用的理解。