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 Shortly thereafter, patients who have been receiving CT will be withdrawn from it as well.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)：一般认为 抗抑郁药物(ADM)和心理治疗的结合更多 对抑郁症的治疗比单独治疗更有效。那里 是否有证据表明，加用认知疗法(CT)可增强 ADM，但大多数相关研究都受到了低功率的影响。此外， 大量研究结果表明，CT具有持久的效果，但大多数 与预防复发有关的证据--回归 与治疗发作相关的症状。几乎没有证据表明 可以说是更关键的预防问题：事先接触CT 预防复发--新的发作的开始。现在需要的是一项研究， 足够敏感，可以检测到添加 CT到ADM，这可以开始解决随之而来的成本效益 问题。建议的设计结合了功效的目标和方法以及 为这些目的进行的有效性研究。我们计划随机将450名忧郁症患者 门诊患者(三个地点各150人)单独接受ADM治疗或ADM+CT治疗。全 患者将使用具有临床代表性的ADM进行治疗以缓解病情 方案，另外一半还将接受CT检查。然后，缓解的患者将被 持续服药长达12个月，直到他们达到 恢复，在此期间将按照临床指示继续进行CT检查 接受综合治疗的患者。一旦康复，患者将被随机 要么接受维持性药物治疗，要么停药。很快就会 此后，一直接受CT治疗的患者将被取消，因为 井。随后将对患者进行为期三年的跟踪调查，目的是 正在检测复发。主要假设是：(1)初始反应将是 与单独使用ADM相比，使用ADM加CT效果更好；以及(2)先前接触CT将 防止停药后再次复发，请注意 与维护ADM的程度相同。将使用分析来估计 将CT添加到ADM中用于急性反应和 预防复发。