2/2-Computer-Assisted Cognitive-Behavior Therapy for Depression

描述(由申请人提供)：我们提出了一项双中心随机对照试验，评估计算机辅助认知行为疗法(CCBT)对严重抑郁障碍(MDD)门诊患者的疗效和成本效益。初步研究结果表明，尽管CCBT将治疗师的接触量减少了约50%，但在抑郁结局方面，CCBT至少与传统的个人CBT一样有效，对功能障碍的态度和关于CBT的知识有更大的影响。我们现在建议对CCBT的治疗等效性和成本效益进行更严格的测试，而不是16周、20疗程的个人CBT，后者提供的治疗接触量是治疗接触量的三倍。总共172名符合SCID/DSM-IV MDD标准的男性和女性门诊患者(每个地点86名)将在五年内随机进行。结果将由独立评估员在不知道所接受治疗的情况下进行评估。这项研究旨在具有统计能力，在急性期治疗结束时和在6个月的随访中测试CCBT和CBT全程的等效性。除了对抑郁症状和明确结果(即应答率和缓解率)的影响外，因变量还将包括功能障碍态度、社会功能、生活质量以及医疗保健成本和利用率的衡量标准。据预测：1)CCBT在第16周和6个月的随访中将相当于CBT；2)CCBT的成本效益将显著高于CBT。次要目标包括测试治疗结果的潜在主持人和预测的无部位差异(作为可传播性的指标)。这项试验对公众健康具有重大影响，因为它将提供一项严格的测试，即CCBT的临床效用与提供三倍临床接触的传统个人治疗模式相比。如果证明了等价性和成本效益，拟议的研究将为评估CCBT更广泛传播的更大规模研究奠定基础。

DESCRIPTION (provided by applicant): We propose a two center, randomized controlled trial evaluating the efficacy and cost-effectiveness of computer-assisted cognitive-behavior therapy (CCBT) for outpatients with major depressive disorder (MDD). Results of a preliminary study indicated that, despite reducing the amount of therapist contact by about 50%, CCBT was at least as effective as an 8 week course of conventional individual CBT on depression outcomes, with greater effects on dysfunctional attitudes and knowledge about CBT. We now propose to conduct a more rigorous test of the therapeutic equivalence and cost-effectiveness of CCBT versus a full 16 week, 20 session course of individual CBT, which provides three times the amount of therapeutic contact. A total of 172 male and female outpatients (86 per site) meeting SCID/DSM-IV criteria for MDD will be randomized across five years. Outcomes will be assessed by independent evaluators without knowledge of the treatment received. The study is designed to have the statistical power to test the equivalence of CCBT and the full course of CBT at both the end of acute phase therapy and across 6 months of follow-up. In addition to effects on depressive symptoms and categorical outcomes (i.e., response and remission rates), dependent variables will include measures of dysfunctional attitudes, social functioning, quality of life, and health care costs and utilization. It is predicted that: 1) CCBT will be equivalent to CBT at week 16 and across the 6 month follow-up; and 2) CCBT will be significantly more cost-effective than CBT. Secondary aims include testing potential moderators of treatment outcome and the predicted absence of site differences (as an indicator of disseminability). This trial has significant implications for the public health because it will provide a rigorous test the clinical utility of CCBT against a model of conventional individual therapy that offers three times as much clinical contact. If equivalence and cost- effectiveness are demonstrated, the proposed research will set the stage for larger scale studies evaluating broader dissemination of CCBT.