Internet CBT for Depression: Comparing Pure, Guided, and Stepped Care

描述(由申请人提供)：抑郁症的循证治疗(EBT)通常无法为需要它们的人提供；心理治疗尤其如此。即使在可获得的情况下，EBTS的交付往往也很差，质量不佳。高昂的直接和间接成本也限制了EBTS的可获得性。这些障碍加在一起，导致了社区中抑郁症的次优治疗。在解决这些质量缺陷的初步步骤中，我们建议对抑郁症进行高保真、互联网传递的认知行为疗法(CBT)的混合疗效-有效性随机对照试验(RCT)，扩展我们之前的研究，以最大限度地提高治疗的可用性和质量，并降低成本。在36个月的招聘期内，我们将从3家农村医疗诊所、3家联邦合格医疗中心(FQHC)和2家非营利性医疗保健机构招募1800名寻求抑郁症护理的成年人。参与者将被随机分为：(A)照常治疗(TAU)控制性条件，通常是抗抑郁药物和/或心理社会服务；(B)TAU+纯自助互联网CBT，包括在不与治疗师联系的情况下访问互联网网站；(C)TAU+引导式自助互联网CBT，包括访问互联网网站，外加与治疗师的简短定期电话联系；或(D)阶梯式护理互联网CBT条件，从TAU纯自助CBT开始，如果早期没有观察到足够的进展，则进展到指导自助CBT。参与者将被跟踪一年。这项研究的主要假设是，指导性自助CBT比纯自助CBT更能改善抑郁症症状。我们也期待二次分析揭示这种结果模式：指导性CBT&GT；纯CBT&GT；TAU。我们将进行成本效益分析(CEA)，因为我们预计每个研究机构的直接成本会有很大差异。我们还将从电子病历(EMR)、计费系统和参与者报告中检查TAU医疗保健利用情况(药物、访问等)。我们假设，相对于指导性和分级护理CBT和TAU，纯CBT的每抑郁无抑郁天数(DFDS)和质量调整生命年(QALY)的成本将是最低的。我们还假设，与指导性CBT相比，阶梯式护理的QALY和DFD改善的单位成本将更好。其他目标包括对次级结果的探索性检查，以及干预措施中结果的预测和调节因素。我们还将收集有关患者、提供者和组织因素的定量和定性数据，这些因素可能会阻碍或促进这些干预措施的实施，以帮助为未来的传播工作做准备。最后，在这次重新应用中，我们增加了一个非研究范围估计阶段，以更好地估计在与真实世界传播密切匹配的条件下的接受率和保留率。 公共卫生相关性：社区抑郁症的治疗往往无法惠及有需要的人，而且在提供时往往质量参差不齐。在治疗师电话支持和不支持的情况下，互联网自助认知行为治疗计划旨在以方便患者的方式和时间，以低成本改善高质量、循证治疗的交付。

DESCRIPTION (provided by applicant): Evidence-based treatments (EBTs) for depression are often not available to persons needing them; this is particularly true of psychotherapies. Even when available, EBTs are often poorly delivered at less-than-optimal quality. High direct and indirect costs also limit the availability of EBTs. Together these barriers contribute to suboptimal treatment of depression in the community. In a preliminary step toward addressing these quality shortcomings, we propose to conduct a blended efficacy- effectiveness randomized controlled trial (RCT) of high fidelity, Internet-delivered cognitive behavioral therapy (CBT) for depression, extending our previous research to maximize treatment availability and quality as well as to reduce costs. Over a 36-month recruitment period, we will enroll 1,800 adults seeking care for depression from 3 rural healthcare clinics, 3 safety net federally qualified healthcare centers (FQHCs), and 2 non-profit HMOs. Participants will be randomized to: (a) a treatment as usual (TAU) control condition, typically antidepressants and/or psychosocial services; (b) TAU plus Pure self-help Internet CBT for depression, consisting of access to the Internet site without any contact with therapists; (c) TAU plus Guided self-help Internet CBT, consisting of access to the Internet site plus brief, periodic telephone contacts with therapists; or (d) a Stepped-Care Internet CBT condition, starting with TAU + Pure self-help CBT and progressing to Guided self-help CBT if adequate progress is not observed early on. Participants will be followed for one year. The primary hypothesis for which the study is powered is that Guided self-help CBT will result in greater depression symptom improvement than Pure self-help CBT. We also expect secondary analyses to reveal this pattern of results: Guided CBT > Pure CBT > TAU. We will conduct cost-effectiveness analyses (CEA), as we project substantial differences in the direct costs of each study arm. We will also examine TAU healthcare utilization (medications, visits, etc) from electronic medical records (EMR), billing systems, and participant report. We hypothesize that cost per depression free days (DFDs) and quality- adjusted life years (QALYs) will be lowest for Pure CBT, relative to Guided and Stepped-Care CBT and TAU. We also hypothesize that cost per unit of improvement in QALYs and DFDs will be better for Stepped-Care compared to Guided CBT. Additional aims include exploratory examination of secondary outcomes, and predictors and moderators of outcomes among the interventions. We also will collect quantitative and qualitative data on patient, provider, and organizational factors that may impede or facilitate implementation of these interventions, to help prepare for future dissemination efforts. Finally, in this reapplication we have added a non-research Reach Estimation Phase to better estimate acceptance and retention rates under conditions that closely match real-world dissemination. PUBLIC HEALTH RELEVANCE: Treatment of depression in the community often does not reach persons in need and is often of mixed quality when it is delivered. The Internet self-help cognitive behavioral therapy program with and without therapist telephone support is meant to improve the delivery of high quality, evidence-based treatment at low cost, in a manner and time convenient for patients.