Prevention of Recurrence in Depression with Drugs and CT

通过药物和 CT 预防抑郁症复发

• 批准号: 6869612
• 负责人: STEVEN DENNIS HOLLON
• 金额: $ 63.25万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-07-16 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6869612
• 关键词: antidepressants; clinical research; cognitive behavior therapy; combination therapy; cost effectiveness; depression; drug withdrawal; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; mental disorder prevention; patient oriented research; relapse /recurrence

DESCRIPTION (provided by applicant): It is commonly believed that the combination of antidepressant medications (ADM) and psychotherapy is more effective in the treatment of depression than is either treatment alone. There is evidence that adding cognitive therapy (CT) enhances the initial effects of ADM, but most of the relevant studies have suffered from low power. Moreover, findings from numerous studies suggest that CT has an enduring effect, but most of the evidence has been relevant to the prevention of relapse - the return of symptoms associated with the treated episode. There is little evidence on what is arguably the more critical prevention question: whether prior exposure to CT prevents recurrence - the onset of new episodes. What is needed is a study that is sensitive enough to detect the benefits that might accompany the addition of CT to ADM, and that can begin to address the attendant cost-effectiveness questions. The proposed design combines the goals and methods of efficacy and effectiveness research to these ends. We plan to randomly assign 450 depressed outpatients (150 at each of three sites) to ADM alone or to ADM plus CT. All patients will be treated to remission with a clinically representative ADM regimen, and half will, in addition, receive CT. Remitted patients will then be continued on medications for up to 12 months until they meet criteria for recovery, during which time CT will be continued as clinically indicated for patients in combined treatment. Once recovered, patients will be randomly assigned to either maintenance medications or medication withdrawal. Shortly thereafter, patients who have been receiving CT will be withdrawn from it as well. Patients will then be followed for a three-year period for the purpose of detecting recurrences. The main hypotheses are: (1) initial response will be better in ADM plus CT, relative to ADM alone; and (2) prior exposure to CT will protect against subsequent recurrence following medication withdrawal, to the same extent as maintenance ADM. Analyses will be employed to estimate the relative cost-effectiveness of adding CT to ADM for acute response and recurrence prevention.

描述（由申请人提供）： 人们普遍认为 抗抑郁药物（ADM）和心理治疗的结合更有效 治疗抑郁症比单独治疗更有效。那里 有证据表明，添加认知疗法 (CT) 可以增强初始效果 ADM，但大多数相关研究都受到低功效的困扰。而且， 大量研究结果表明 CT 具有持久的效果，但大多数 的证据与预防复发相关 - 返回 与所治疗的发作相关的症状。几乎没有证据表明什么 可以说是更关键的预防问题：之前是否暴露于 CT 防止复发——新的发作的发生。所需要的是一项研究 足够灵敏，可以检测到添加可能带来的好处 CT 到 ADM，这可以开始解决随之而来的成本效益问题 问题。所提出的设计结合了功效和效果的目标和方法 为达到这些目的进行有效性研究。我们计划随机分配 450 名抑郁者 门诊患者（三个地点各 150 名）单独接受 ADM 治疗或接受 ADM 加 CT 治疗。全部 患者将通过具有临床代表性的 ADM 治疗达到缓解 此外，一半人还将接受 CT 治疗。缓解后的患者将被 继续服药长达 12 个月，直至达到以下标准： 恢复期，在此期间将根据临床指示继续进行 CT 检查 患者进行综合治疗。一旦康复，患者将被随机分配 分配给维持药物或停药。不久 此后，已接受 CT 治疗的患者将退出 CT 治疗。 出色地。然后将对患者进行为期三年的随访，目的是 检测复发情况。主要假设是： (1) 最初的反应是 相对于单独使用 ADM，ADM 联合 CT 效果更好； (2) 事先接受 CT 照射将 防止停药后复发， 与维护 ADM 的程度相同。将采用分析来估计 将 CT 添加到 ADM 中以实现急性反应的相对成本效益 预防复发。