Prevention of Recurrence in Depression with Drugs and CT

描述（由申请人提供）：本项目是对编号为no - od -10-032和标题为《NIH宣布通过NIH基础行为和社会科学机会网络（OppNet）获得竞争性修订申请（R01, R03, R15， R21/R33和R37）的恢复法案基金》的回应。侧重于数据分析方法，使研究人员能够调查心理健康和行为问题的潜在机制和过程，这些问题是在广泛的行为研究领域的预防和治疗方案所针对的。具体来说，这项工作将评估统计建模方法，这些方法可用于检查预防和治疗方案（介质）的目标过程，当结果以事件发生（生存数据）的时间为单位进行测量时，从而为考虑使用这些方法的研究人员提供指导。父母赠款的重点是治疗重度抑郁症，但作为提案的一部分，将与一名主要的方法和健康促进及疾病预防研究人员建立合作。此外，这些方法将适用于除抑郁症以外的精神健康障碍、药物滥用和健康行为（例如体重控制），不需要在应用研究的背景下使用，尽管在父母补助金的情况下将使用这些方法。父母资助的“用药物和认知疗法预防抑郁症复发”是nimh资助的一项多地点试验，在该试验中，抑郁症门诊患者被随机分配到单独使用抗抑郁药物（ADM）或使用ADM和认知疗法（CT）。它的设计功率足以：1)发现在ADM中加入CT对治疗反应和预防复发可能带来的好处，2)探索治疗的预测因素和潜在过程，并评估它们与症状改善的关系（行为和社会科学的基本研究目标），潜在地阐明添加CT如何产生额外的好处，并为如何改善抑郁症的治疗提供信息。多种认知变化和治疗过程的测量正在被收集，以检验这些结构作为症状改善的潜在机制的假设。拟议的模拟工作不包括在原来的母补助金内，将有助于确保采用最佳办法来实现这一目标。

DESCRIPTION (provided by applicant): This project, a response to notice number NOT-OD-10-032 and notice title NIH Announces the Availability of Recovery Act Funds for Competitive Revision Applications (R01, R03, R15, R21/R33, and R37) through the NIH Basic Behavioral and Social Science Opportunity Network (OppNet), focuses on approaches to data analysis that allow researchers to investigate underlying mechanisms and processes of mental health and behavioral problems that are targeted by prevention and treatment programs in a wide range of behavioral research areas. Specifically, the work will evaluate statistical modeling approaches that can be used to examine processes targeted by prevention and treatment programs (mediators) when outcomes are measured as time until the onset of an event (survival data), and thereby provide guidance to researchers who consider using these approaches. The parent grant focuses on treatment for major depressive disorder, but as part of the proposal, collaboration will be established with a leading methodological and health promotion and disease prevention researcher. Furthermore, these approaches would apply to mental health disorders other than depression, to substance abuse, and to health behaviors (e.g., weight control), and need not be utilized in the context of applied research, though they will be in the case of the parent grant. The parent grant, Prevention of Recurrence in Depression with Drugs and Cognitive Therapy, is an NIMH-funded multi-site trial in which depressed outpatients have been randomized to antidepressant medications (ADM) alone or to ADM and cognitive therapy (CT). It was designed with power sufficient to: 1) detect benefits that might accompany the addition of CT to ADM with respect to treatment response and the prevention of recurrence, and 2) explore predictors and underlying processes that are targeted by the treatments, and assess their relationships to symptom improvement (a basic behavioral and social sciences research goal), potentially elucidating how additional benefits might accrue from adding CT and providing information about how to improve treatments for depression. Measures of multiple kinds of cognitive changes and treatment processes are being collected in order to test hypotheses about these constructs as underlying mechanisms of symptom improvement. The proposed simulation work, which is not included in the original parent grant, will help to ensure that the best approaches are used to achieve this aim. PUBLIC HEALTH RELEVANCE: Depression is one of the most prevalent and debilitating of the psychiatric disorders. By yielding estimates of the benefit of adding psychotherapy to medication therapy in the treatment of depression, and identifying subgroups of patients who most benefit from combined treatment, findings from this project will be able to guide clinicians in selecting treatments, and improving outcomes. In addition, mechanisms and processes that influence outcome will be studied, which will have the potential to lead to new treatment approaches and further improved outcomes.