Are Cognitive Therapy's Antidepressant Effects Durable?

认知疗法的抗抑郁效果持久吗？

• 批准号: 6707182
• 负责人: MICHAEL E THASE
• 金额: $ 30.13万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6707182
• 关键词: adult human (21+); antidepressants; behavioral /social science research tag; chemotherapy; clinical research; clinical trials; cognitive behavior therapy; depression; fluoxetine; human subject; human therapy evaluation; longitudinal human study; mental health epidemiology; patient oriented research; relapse /recurrence

DESCRIPTION (provided by applicant): We propose adding a 2 year follow-up to a funded, randomized clinical trial evaluating the efficacy of and indications for 8 months of continuation phase cognitive therapy (C-CT), pharmacotherapy (fluoxetine; FLX), and pill placebo (PBO) in outpatients with recurrent major depressive disorder (MDD) who are at higher risk for relapse. This initial project period will allow comment in the comparative durability of effects after the first year of follow-up after all protocol treatment is discontinued. In addition, we will begin to accrue data to evaluate the durability of effects over two years of follow-up. The trial and follow-up will be conducted by investigators at the University of Texas Southwestern Medical Center and the University of Pittsburgh School of Medicine. "Higher risk" is defined by incomplete remission during the final weeks of acute phase CT, while "lower risk" is defined as complete and stable remission (i.e., 7 consecutive Hamilton Rating Scale for Depression scores <7). This trial has great public health significance because it will help identify when CT reduces the risk of relapse and recurrence in patients suffering from recurrent MDD, an illness with high morbidity and mortality. Patients with the highest risk for relapse can then be targeted for the most vigorous preventive treatment. This study is also the first to evaluate the continuation phase pharmacotherapy (FLX) after incomplete remission with acute phase CT. This contrast is important because many patients do not have adequate insurance coverage to support the full course of acute CT plus continuation phase CT. Further, the pharmacotherapy group will permit tests of mode-specific vs. nonspecific therapeutic activity. The follow-up is important because it will allow comment not only on C-CT's preventive effect on relapse (while patients receive it) but also on recurrence (after it is discontinued). In this application, we propose to enter an additional 159 male and female outpatients, aged 18-70 with DSM-IV unipolar, nonpsychotic, recurrent MDD to 16 or 20 sessions of acute phase CT in order to have sufficient power to compare effects over the first year of follow-up. Additional responders at higher risk for relapse will be randomized to 8 months of: (a) C-CT, (b) FLX, or (c) PBO and then followed for 2 years; lower risk patients will be followed for 32 months after acute phase CT. Dependent variables measure response, relapse, recurrence, remission, and recovery. Blind evaluations and survival analysis are planned.

描述（由申请人提供）：我们建议在一项资助的，随机的临床试验中增加2年的随访，该试验评估了8个月持续阶段认知疗法（C-CT）（C-CT），药物治疗（Fluoxetine; FLX），FLX）的功效和适应症的疗效和药丸安慰剂（PBO）在复发性重度抑郁症（MDD）的门诊病人中，患有更高的复发风险。最初的项目期限将允许在停止所有协议处理后的第一年后期后对效果的比较持久性发表评论。此外，我们将开始累积数据，以评估两年后随访的效果持久性。该试验和随访将由德克萨斯大学西南医学中心和匹兹堡大学医学院的调查人员进行。 “较高的风险”是由急性期CT的最后几周不完全缓解来定义的，而“较低的风险”定义为完全稳定的缓解（即，抑郁症得分的连续7个汉密尔顿连续汉密尔顿评级量表<7）。该试验具有很高的公共健康意义，因为它将有助于确定CT何时降低患有复发性MDD的患者复发和复发的风险，这是一种高发病率和死亡率的疾病。然后可以将重复风险最高的患者用于最剧烈的预防治疗。这项研究也是第一个评估急性相CT不完全缓解后延续阶段药物治疗（FLX）的研究。这种对比很重要，因为许多患者没有足够的保险覆盖范围来支持急性CT和CT持续阶段CT的完整过程。此外，药物治疗组将允许对模式特异性与非特异性治疗活性进行测试。随访非常重要，因为它不仅允许对C-CT对复发的预防作用（患者接受）的评论，而且还允许对复发的复发作用（在中断之后）。在此应用程序中，我们建议进入另外159名男性和女性门诊患者，年龄18-70岁，DSM-IV单极，非精神病性，反复发作的MDD至16或20个急性期CT，以便具有足够的能力，可以比较效果。随访的第一年。较高的复发风险的其他响应者将随机分为8个月：（a）C-CT，（b）FLX或（c）PBO，然后遵循2年；急性CT后32个月，降低风险患者。因变量测量反应，复发，复发，缓解和恢复。计划盲目评估和生存分析。