Online Treatments for Mood and Anxiety Disorders in Primary Care

描述(由申请人提供)：抑郁症和焦虑症在初级保健实践中很普遍，与健康相关的生活质量(HRQOL)大幅下降有关，并产生显著的过度发病率。对此，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”对这些疾病具有更好的效果。然而，由于各种原因，这些模式并未得到广泛实施。因此，迫切需要开发和测试更具可扩展性、更强大和更创新的协作护理版本，同时更好地理解如何通过初级保健最好地提供这些干预措施，因为大多数抑郁症和焦虑患者寻求治疗。数以千计的网站提供医疗信息，公众可以在其中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，几种计算机化认知行为疗法(CCBT)已被证明对治疗情绪和焦虑障碍患者有效，并在美国以外的数十万患者中使用。然而，CCBT在美国国内使用仍然很少，也没有试验将CCBT纳入协作性护理干预或检查CCBT与ISG相结合治疗这些障碍的有效性。我们提出了一项为期4年的比较有效性试验，将700名年龄在18-75岁之间、至少有中等水平的情绪和/或焦虑症状并可靠地访问互联网和电子邮件的初级保健患者随机分为以下两组：(1)引导患者访问Beat the Blues，一个被证明有效的在线CCBT计划(单独CCBT；N=300)；(2)引导患者访问Beat the Blues加适度的ISG(CCBT+ISG；N=300)；或(3)他们的PCP的“日常护理”(N=100)。我们的基本假设是，在6个月的随访中，与CCBT+ISG组患者相比，CCBT+ISG组患者在SF-12 MCS上的HRQL值将达到临床有意义的0.30效果大小(ES)或更大的改善，我们将再监测患者6个月，以评估我们干预措施的持久性。我们的第二个假设是，在6个月的随访中，仅接受CCBT治疗的患者在SF-12 MCS上的HRQL改善程度将达到0.50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精神卫生治疗，我们还将评估：(A)跨年龄段和各年龄段的有效性；(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)我们的干预措施对哪些患者可能特别有效；以及(E)在项目干预阶段之后采用和维持我们的干预措施的做法。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影响，并使其他美国调查人员进一步关注新兴的电子心理健康领域。

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.