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）对门诊重度抑郁症（MDD）患者的疗效和成本效益。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，但CCBT对抑郁结果的影响至少与8周的常规个体CBT疗程一样有效，对功能失调态度和CBT知识的影响更大。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，而单独的CBT则提供了三倍的治疗接触量，为期16周，20次的课程。总共172名符合SCID/DSM-IV重度抑郁症标准的男性和女性门诊患者（每个站点86名）将在五年内随机分组。结果将由不了解所接受治疗的独立评估人员评估。在急性期治疗结束和6个月的随访中，该研究旨在具有统计学能力来检验CCBT和CBT全疗程的等效性。除了对抑郁症状和分类结果（即反应率和缓解率）的影响外，因变量还包括功能失调态度、社会功能、生活质量和医疗保健费用和利用等指标。预测：1)CCBT在第16周及6个月随访期间与CBT相当；2) CCBT将显著优于CBT。次要目的包括测试治疗结果的潜在调节因子和预测不存在地点差异（作为可传播性的指标）。这项试验对公共卫生具有重大意义，因为它将对CCBT与提供三倍临床接触的传统个体治疗模式的临床效用进行严格测试。如果等效性和成本效益得到证明，拟议的研究将为评估CCBT的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. PUBLIC HEALTH RELEVANCE: Although Cognitive Behavior Therapy (CBT) is an effective treatment for major depressive disorder, its utility is limited by cost and availability of trained therapists. Computer-assisted delivery of this therapy (CCBT) has shown promise and may offer similar benefits as CBT with as little as one third the amount of therapist time. The proposed study will test the therapeutic equivalence and cost-effectiveness of CCBT versus CBT across a 16 week acute phase and a 6 month follow-up.