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

描述（由申请人提供）：我们提出了一个两个中心，随机对照试验，评估计算机辅助认知行为治疗（CCBT）的有效性和成本效益的门诊患者与重性抑郁症（MDD）。一项初步研究的结果表明，尽管减少了约50%的治疗师接触量，CCBT至少与为期8周的常规个人CBT课程一样有效，对抑郁症的结果有更大的影响，对CBT的功能失调态度和知识有更大的影响。我们现在建议进行更严格的治疗等效性和成本效益的测试CCBT与一个完整的16周，20个疗程的个人CBT，它提供了三倍的治疗接触。将在5年内对符合MDD的SCID/DSM-IV标准的共172例男性和女性门诊患者（每个研究中心86例）进行随机分组。结局将由不了解所接受治疗的独立评价者进行评估。本研究旨在具有统计学把握度，以检验CCBT和CBT全疗程在急性期治疗结束时和6个月随访期间的等效性。除了对抑郁症状和分类结果的影响（即，反应和缓解率），因变量将包括功能失调的态度，社会功能，生活质量和卫生保健费用和利用的措施。据预测：1）CCBT在第16周和6个月随访期间与CBT相当; 2）CCBT的成本效益明显高于CBT。次要目的包括测试治疗结果的潜在调节因素和预测的不存在部位差异（作为传播性的指标）。这项试验对公众健康具有重大意义，因为它将提供一个严格的测试CCBT的临床效用与传统的个体治疗模式，提供三倍的临床接触。如果等效性和成本效益得到证明，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.