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普遍存在，与健康相关生活质量（HRQoL）的大幅降低相关，并产生显著的过度发病率。作为回应，数十项试验已经证明，与初级保健医生的常规护理相比，“协作护理”对这些疾病的效果更好。然而，由于种种原因，这些模式尚未得到广泛实施。因此，迫切需要开发和测试更具可扩展性，功能强大和创新的协作护理版本，同时更好地了解如何通过初级保健提供这些干预措施，大多数抑郁和焦虑患者寻求治疗。 数以千计的网站提供医疗信息，公众可以交流治疗信息的互联网支持小组的数量正在激增。尽管如此，临床试验还没有确定以这种方式使用互联网的好处。与这些发展同时，几种计算机化认知行为治疗（CCBT）程序已被证明在治疗情绪和焦虑症患者方面有效，并被美国以外的数十万患者使用。没有试验将CCBT纳入协作护理干预或检查CCBT与ISG联合治疗这些疾病的有效性。 我们提出了一个为期4年的比较有效性试验，将随机选择700名年龄在18-75岁之间的初级保健患者，这些患者至少有中度的情绪和/或焦虑症状，并且可以可靠地访问互联网和电子邮件：（1）引导患者访问Beating the Blues，这是一个被证明有效的在线CCBT计划（单独CCBT; N=300）;（2）引导患者进入Beating the Blues加进入适度ISG（CCBT+ISG; N=300）;或（3）PCP的“常规护理”（N=100）。我们的主要假设是，在6个月随访时，CCBT+ISG组的患者将报告SF-12 MCS的HRQoL的具有临床意义的0.30效应量（ES）或更大改善，与CCBT单药组的患者相比，我们将对患者进行额外6个月的监测，以评价我们干预措施的持久性。我们的次要假设是，在6个月随访时，单独CCBT患者将报告SF-12 MCS的HRQoL比“常规治疗”改善0.50 ES或更大。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）其跨年龄层和年龄层内的有效性;（B）其成本效益;（c）患者如何利用我们的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）我们的干预措施可能特别有效。以及（e）在项目干预阶段之后，通过实践采用和维持我们的干预措施。研究结果可能会对改变初级保健中治疗精神健康状况的方式产生深远的影响，并进一步关注其他美国研究人员对新兴的电子精神健康领域的关注。

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.