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）通常无法提供给需要的人；这在心理治疗中尤其如此。即使有，ebt也经常以低于最佳质量的差交付。高昂的直接和间接成本也限制了电子商务培训的可用性。这些障碍共同导致了社区对抑郁症的治疗不理想。在解决这些质量缺陷的初步步骤中，我们建议进行一项高保真度的混合疗效随机对照试验（RCT），通过互联网提供认知行为疗法（CBT）治疗抑郁症，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个月的招募期内，我们将从3个农村医疗保健诊所、3个联邦安全网合格医疗保健中心（FQHCs）和2个非营利hmo招募1800名寻求抑郁症治疗的成年人。参与者将被随机分配到：(a)常规治疗（TAU）对照条件，通常是抗抑郁药物和/或心理社会服务；(b) TAU加治疗抑郁症的纯自助网络CBT，包括在不与治疗师联系的情况下访问互联网站点；(c) TAU加上有指导的自助互联网CBT，包括访问互联网网站以及与治疗师进行简短的定期电话联系；或(d)渐进式网络CBT治疗，从TAU +纯自助CBT开始，如果早期没有观察到足够的进展，则进展到引导自助CBT。参与者将被跟踪一年。该研究支持的主要假设是，与纯粹的自助CBT相比，引导自助CBT会导致更大的抑郁症状改善。我们也希望二次分析能揭示这种模式的结果：引导CBT >纯CBT > TAU。我们将进行成本效益分析（CEA），因为我们预计每个研究组的直接成本存在实质性差异。我们还将从电子医疗记录（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、就诊等）。我们假设，相对于指导式、阶梯式护理式CBT和TAU，纯CBT的每无抑郁日（DFDs）和质量调整生命年（QALYs）成本最低。我们还假设，与引导CBT相比，阶梯式护理的QALYs和DFDs的单位改善成本更低。其他目的包括对次要结果的探索性检查，以及干预措施中结果的预测因子和调节因子。我们还将收集可能阻碍或促进这些干预措施实施的患者、提供者和组织因素的定量和定性数据，以帮助为未来的传播工作做好准备。最后，在这个重新申请中，我们添加了一个非研究性的到达评估阶段，以便在与现实世界传播密切匹配的条件下更好地评估接受率和留存率。

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.