Are Cognitive Therapy's Antidepressant Effects Durable?

描述(由申请人提供)：我们建议在一项资助的随机临床试验中增加2年的随访，评估8个月持续阶段认知疗法(C-CT)、药物疗法(氟西汀；Flx)和药片安慰剂(PBO)对复发风险较高的严重抑郁障碍(MDD)门诊患者的疗效和适应症。这一初步项目期将允许在所有礼宾治疗停止后的第一年后续行动后，对效果的相对耐久性进行评论。此外，我们将开始积累数据，以评估两年随访的效果的持久性。试验和后续研究将由德克萨斯大学西南医学中心和匹兹堡大学医学院的研究人员进行。“高风险”被定义为在急性期CT的最后几周内不完全缓解，而“低风险”被定义为完全和稳定的缓解(即，连续7个汉密尔顿抑郁量表评分和7)。这项试验具有重大的公共卫生意义，因为它将有助于确定CT何时降低复发MDD患者的复发和复发风险。MDD是一种发病率和死亡率都很高的疾病。然后，可以针对复发风险最高的患者进行最有力的预防性治疗。这项研究也是首次通过急性期CT评估不完全缓解后继续期药物治疗(FLX)的效果。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加延续期CT的整个疗程。此外，药物治疗组将允许对特定模式与非特定治疗活动进行测试。随访是重要的，因为它不仅允许评论C-CT对复发的预防效果(当患者接受它时)，也允许评论关于复发的(在停止它之后)。在这项研究中，我们建议将另外159名年龄在18-70岁、患有DSM-IV单相、非精神病、复发性MDD的男性和女性患者纳入16或20个疗程的急性期CT，以便有足够的能力比较第一年的随访效果。复发风险较高的其他应答者将随机接受8个月的治疗：(A)C-CT、(B)Flx或(C)PBO，然后随访2年；急性期CT后，低风险患者将被跟踪32个月。因变量衡量反应、复发、复发、缓解和恢复。计划进行盲法评估和生存分析。

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.