Online Treatments for Mood and Anxiety Disorders in Primary Care

描述（由申请人提供）：抑郁和焦虑在初级保健实践中很普遍，与健康相关生活质量（HRQoL）的大幅下降有关，并产生显著的过度发病率。作为回应，数十项试验表明，与初级保健医生的常规护理相比，“协作护理”对这些疾病更有效。然而，由于种种原因，这些模型尚未得到广泛实施。因此，迫切需要开发和测试更可扩展、更强大、更创新的协作护理版本，同时更深入地了解如何通过初级保健（大多数抑郁症和焦虑症患者寻求治疗的地方）最好地提供这些干预措施。成千上万的网站提供医疗信息，公众可以交换治疗信息的互联网支持小组（ISG）的数量正在激增。尽管如此，临床试验还没有确定以这种方式利用互联网的好处。与此同时，一些计算机化认知行为疗法（CCBT）项目已被证明对治疗情绪和焦虑症患者有效，并被美国以外的数十万患者使用。然而，CCBT在美国国内的应用仍然很少，没有试验将CCBT纳入协作护理干预，也没有试验检验将CCBT与ISG结合治疗这些疾病的有效性。我们提出了一项为期4年的比较有效性试验，将随机抽取700名年龄在18-75岁之间，至少有中度情绪和/或焦虑症状，并且可以可靠地访问互联网和电子邮件的初级保健患者：(1)指导患者访问beat the Blues，这是一个已被证明有效的在线CCBT项目（单独CCBT， N=300）；(2)引导患者进入beat Blues +有调节的ISG (CCBT+ISG， N=300)；(3) PCP的“日常护理”（N=100）。我们的主要假设是，在6个月的随访中，与单独CCBT组相比，CCBT+ISG组患者在SF-12 MCS上的HRQoL改善有临床意义的0.30效应量（ES）或更大，我们将对患者进行额外6个月的监测，以评估我们干预措施的耐用性。我们的次要假设是，在6个月的随访中，与“常规治疗”相比，单独使用ccbt的患者在SF-12 MCS上的HRQoL改善为0.50 ES或更高。为了更好地了解如何通过初级保健最好地提供在线心理健康治疗，我们还将评估：(a)它们在不同年龄层和不同年龄层内的有效性；(b)其成本效益；(c)患者如何利用我们干预措施的组成部分；(d)我们的干预措施可能特别有效的患者亚组；(e)在项目干预阶段之后，通过实践采用和维护我们的干预措施。研究结果可能会对改变初级保健中心理健康状况的治疗方式产生深远的影响，并使其他美国研究人员进一步关注电子心理健康的新兴领域。

DESCRIPTION (provided by applicant): Depression and anxiety are prevalent in primary care practice, associated with substantial reductions in health-related quality of life (HRQoL), and generate a significant excess of morbidity. In response, dozens of trials have demonstrated the greater effectiveness of "Collaborative Care" for these conditions vs. primary care physicians' usual care. Yet for a variety of reasons, these models have not been widely implemented. Therefore, an urgent need remains to develop and test more scalable, powerful, and innovative versions of Collaborative Care while simultaneously developing a greater understanding of how best to provide these interventions through primary care where the majority of depressed and anxious patients seek treatment. Thousands of web sites provide medical information and the number of Internet support groups (ISG) where the public can exchange information about treatments is proliferating. Still, clinical trials have not established the benefits of utilizing he Internet in this manner. Concurrent with these developments, several computerized cognitive behavioral therapy (CCBT) programs have been proven effective at treating patients with mood and anxiety disorders and used by hundreds of thousands of patients outside the U.S. Yet CCBT remains little utilized inside the U.S., and no trials have incorporated CCBT into a Collaborative Care intervention or examined the effectiveness of combining CCBT with an ISG for these disorders. We propose a 4-year comparative effectiveness trial that will randomize 700 primary care patients aged 18-75 who have at least a moderate level of mood and/or anxiety symptoms and reliable access to both the Internet and e-mail to either: (1) guided patient access to Beating the Blues, a proven-effective on-line CCBT program (CCBT-alone; N=300); (2) guided patient access to Beating the Blues plus access to a moderated ISG (CCBT+ISG; N=300); or (3) their PCP's "usual care" (N=100). Our primary hypothesis is that patients in our CCBT+ISG arm will report a clinically meaningful 0.30 effect size (ES) or greater improvement in HRQoL on the SF-12 MCS compared to patients in our CCBT-alone arm at 6-months follow-up, and we will monitor patients for an additional 6 months to evaluate the durability of our interventions. Our secondary hypothesis is that CCBT-alone patients will report a 0.50 ES or greater improvement in HRQoL on the SF-12 MCS versus "usual care" at 6-months follow-up. To better understand how online mental health treatments are best provided through primary care, we will also evaluate: (a) their effectiveness across and within age strata; (b) their cost-effectiveness; (c) how patients utilize the components of our interventions; (d) patient subgroups for whom our interventions may be particularly effective; and (e) the adoption and maintenance of our interventions by practices following the Intervention Phase of the Project. Study findings are likely to have profound implications for transforming the way mental health conditions are treated in primary care and focus further attention to the emerging field of e-mental health by other U.S. investigators. PUBLIC HEALTH RELEVANCE: Depression and anxiety are common in primary care practice and are associated with substantial reductions in health-related quality of life. This Project will test the comparative effectiveness of two on-line treatments for these conditions provided through the context of a Collaborative Care program: (1) moderated access to a proven-effective computerized cognitive behavioral therapy (CCBT) program; versus (2) moderated access to CCBT plus an Internet support group (CCBT+ISG). The Project will also compare the effectiveness of these treatments to PCPs' "usual care" for these conditions, and evaluate the adoption and maintenance of CCBT+ISG by practices following the conclusion of the trial to provide a greater understanding of how to best scale the delivery of these interventions into a variety of primary care settings.