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

互联网 CBT 治疗抑郁症：比较纯粹护理、引导护理和阶梯护理

• 批准号: 8508455
• 负责人: GREGORY N CLARKE
• 金额: $ 14.01万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2015-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8508455
• 关键词: Address; Adherence; Adult; Antidepressive Agents; Behavior Therapy; Behavioral; Caring; Chronic Disease; Clinic; Clinical; Cognitive Therapy; Communities; Community Healthcare; Computerized Medical Record; Consent; Data; Direct Costs; Disease; Dose; Drug abuse; Educational Materials; Effect Modifiers (Epidemiology); Effectiveness; Electronic Mail; Enrollment; Evaluation Research; Evidence based treatment; Facilities and Administrative Costs; Future; Guidelines; Health; Health Personnel; Health Services Accessibility; Healthcare; Healthcare Systems; Institutes; Instruction; Internet; Intervention; Literature; Major Depressive Disorder; Marketing; Mental Depression; Mental Health; Methods; Modeling; NIH Program Announcements; Outcome; Participant; Patient Monitoring; Patients; Pattern; Persons; Pharmaceutical Preparations; Phase; Population; Primary Health Care; Professional counselor; Provider; Psychiatric Social Work; Psychotherapy; Qualifying; Quality of Care; Quality-Adjusted Life Years; Randomized; Randomized Controlled Trials; Reapplication; Recruitment Activity; Relative (related person); Reporting; Research; Research Personnel; Residual state; Rural; Rural Community; Sample Size; Sampling; Self-Administered; Services; Site; Specialist; Speed; Stigmata; System; Technology; Telemedicine; Telephone; Testing; Time; Translational Research; Translations; Variant; Visit; arm; base; care seeking; comparative effectiveness; compliance behavior; cost; cost effectiveness; demographics; depressive symptoms; dissemination research; effectiveness research; effectiveness trial; health care service organization; health care service utilization; implementation research; improved; interest; medical specialties; novel; programs; public health relevance; racial and ethnic; response; rural area; safety net; secondary outcome; self help; social stigma; socioeconomics; success; treatment as usual; trial comparing

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.

描述（由申请人提供）：抑郁症的循证治疗（EBT）往往无法提供给需要它们的人;心理治疗尤其如此。即使有，EBT也往往质量不佳。直接和间接费用高也限制了电子商务技术的可获得性。这些障碍共同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，我们建议进行一项混合疗效-有效性随机对照试验（RCT），高保真，互联网提供的认知行为疗法（CBT）治疗抑郁症，扩展我们以前的研究，以最大限度地提高治疗的可用性和质量，并降低成本。在为期36个月的招募期内，我们将招募1,800名来自3个农村医疗诊所、3个安全网联邦合格医疗中心（Safety net federalally qualified healthcare centers，简称SAHC）和2个非营利性HMO的抑郁症患者。受试者将被随机分配至：（a）常规治疗（TAU）对照组，通常为抗抑郁药和/或心理社会服务;（B）TAU加纯自助互联网CBT治疗抑郁症，包括访问互联网网站而不与治疗师进行任何接触;（c）TAU加引导式自助互联网CBT，包括访问互联网网站加上与治疗师进行简短的定期电话联系;或（d）互联网CBT分级护理条件，从TAU +纯自助CBT开始，如果早期没有观察到足够的进展，则进展到引导自助CBT。参与者将被随访一年。该研究的主要假设是，引导自助CBT将导致比纯自助CBT更大的抑郁症状改善。我们还期望二次分析揭示这种结果模式：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显著差异。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（药物、访视等）。我们假设，相对于指导和分步护理CBT和TAU，纯CBT的每无抑郁日（DFD）和质量调整生命年（QFD）成本最低。我们还假设，与指导性CBT相比，分步护理在QFD和DFD方面的每单位改进成本将更好。其他目的包括探索性检查次要结果，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好准备。最后，在这个重新申请中，我们增加了一个非研究范围估计阶段，以更好地估计在与现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达不到有需要的人，而且在提供治疗时往往质量参差不齐。互联网自助认知行为治疗计划，有和没有治疗师的电话支持，是为了提高提供高质量，以证据为基础的治疗，以低成本，在方便患者的方式和时间。