A comparison of cognitive and dynamic therapy for MDD in community settings

描述（由申请人提供）：当前提案的目标是进行一项随机的、比较的、非劣效性的临床试验，以检验广泛使用的手动动态心理治疗（支持性表达心理动力治疗）在社区精神卫生机构治疗重度抑郁症时并不逊于认知治疗的假设。重度抑郁症是一种严重的致残障碍，在美国，每年有7%的人患有抑郁症，一生中大约有17%的人患有抑郁症（Kessler et al., 2005）。在过去的30年里，认知疗法（Beck et al., 1979）已被确立为最具经验验证的重度抑郁症心理社会治疗方法（Hollon, Thase, & Markowitz, 2002）。在这个时间点上，广泛的努力正在发生传播认知疗法的临床实践设置。卫生系统和管理护理实体已经开始加速向在社区机构工作的现有心理治疗师传播认知疗法。尽管对认知疗法进行了大量的研究，但与精神卫生保健系统和机构相关的一个核心问题从未得到解决，即认知疗法是否比许多以社区为基础的心理治疗师提供的典型形式的心理治疗提供更好的结果。如果一种标准形式的心理治疗（即心理动力疗法）在社区中已经很普遍，其效果并不比认知疗法差，那么对社区治疗师进行认知疗法再培训所需的大量资金，最好花在其他提高质量的举措上，包括雇佣新的治疗师来帮助解决社区中普遍存在的人员不足问题。当前建议的具体目的是：1)进行一项随机非劣效性试验，比较支持表达心理动力疗法和认知疗法对重度抑郁症患者的治疗效果；2)评估支持表达疗法和认知疗法在患者功能和生活质量的次要测量方面的比较效果。在协议的第一年，在社区精神卫生机构工作的治疗师将接受认知治疗或动态心理治疗方面的培训。此外，为了在整个研究期间保留适当数量的治疗师，将在整个研究期间实施并行治疗师培训程序。在两个社区心理健康中心寻求服务的消费者将随机接受12次认知治疗或动态心理治疗。所有的心理治疗将由社区机构雇用的治疗师提供，并将在社区机构进行。在心理健康机构被诊断为重度抑郁症的消费者将被邀请参与目前的协议。感兴趣的消费者将同意参与研究并随机接受治疗。所有参与者将完成基线访谈以及每月抑郁症状、功能和生活质量评估。作为正常临床程序的一部分，所有消费者也将在基线和每次治疗期间完成BASIS-24。我们将评估动态心理治疗是否不劣于认知治疗从基线到急性治疗终点的HAM-D总分的变化。如果心理动力疗法不逊于认知疗法，那么对心理治疗师进行认知疗法再培训的费用可能是不合理的。

DESCRIPTION (PROVIDED BY APPLICANT): The goal of the current proposal is to conduct a randomized, comparative, non-inferiority clinical trial that tests the hypothesis that a widely used form of manualized dynamic psychotherapy (supportive expressive psychodynamic therapy) is not inferior to cognitive therapy when implemented in community mental health settings for the treatment of major depressive disorder. Major depressive disorder is a severe and disabling disorder afflicting 7% of individuals in the United States annually and approximately 17% of individuals across their lifetime (Kessler et al., 2005). Over the past 30 years, cognitive therapy (Beck et al., 1979) has become established as the most empirically-validated psychosocial treatment for major depressive disorder (Hollon, Thase, & Markowitz, 2002). At this point in time, extensive efforts are occurring to disseminate cognitive therapy to clinical practice settings. Health systems and managed care entities have begun to accelerate dissemination of cognitive therapy to existing psychotherapists working in community agencies. Despite the large number of studies that have been done on cognitive therapy, one central question relevant to mental health care systems and agencies that has never been addressed is whether or not cognitive therapy provides superior outcomes to the typical form of psychotherapy provided by many community-based psychotherapists. If a standard form of psychotherapy (i.e., psychodynamic therapy) already common in the community produces outcomes that are not inferior to those produced by cognitive therapy, then the extensive amount of funds needed to re-train community therapists in cognitive therapy would be better spent on other quality improvement initiatives including hiring new therapists to help with the understaffing that is prevalent in the community. The Specific Aims of the current proposal are 1) to conduct a randomized non-inferiority trial to compare supportive-expressive psychodynamic therapy and cognitive therapy for patients with major depressive disorder, and 2) to assess the comparative effectiveness of supportive-expressive therapy and cognitive therapy on secondary measures of patient functioning and quality of life. Therapists working in community mental health agencies will be trained in either cognitive therapy or dynamic psychotherapy during the first year of the protocol. In addition, concurrent therapist training procedures will be implemented across the study period in order to retain the appropriate number of therapists throughout the study. Consumers seeking services at two community mental health centers will be randomized to either receive 12 sessions of cognitive therapy or dynamic psychotherapy. All psychotherapy will be provided by therapists employed at the community agency and will take place at the community agency. Consumers diagnosed with major depressive disorder at the mental health agency will be offered participation in the current protocol. Interested consumers will be consented for the study and randomized to treatment. All participants will complete a baseline interview as well as monthly assessments of depressive symptoms, functioning, and quality of life. As part of normal clinic procedures, all consumers will also complete the BASIS-24 at baseline and at each treatment session. We will evaluate whether dynamic psychotherapy is not inferior to cognitive therapy on change from baseline to endpoint of acute treatment in the HAM-D total score. If psychodynamic therapy is not inferior to cognitive therapy, the cost of re-training psychotherapists in cognitive therapy may not be warranted.