Development and testing of a behavioral activation mobile therapy for elevated depressive symptoms

项目摘要/摘要 抑郁症是全球残疾的主要原因，有超过3亿人受到影响。大多数成年人 有抑郁症状的人每年至少去看一次初级保健医生(PCP)。因此，主要的 CARE为识别和治疗患有抑郁症状的成年人提供了一个成熟的机会。然而，抑郁症已经 从历史上看，在初级保健中受到的治疗不足，超过三分之二的美国成年人筛查呈阳性 抑郁症不接受治疗。移动健康(MHealth)技术，特别是移动应用程序，可提供 通过初级保健满足循证心理治疗需求的理想策略。通过我们的阶段 我们开发了一款名为Moodivate的自助移动应用程序，并对其进行了初步临床评估 由抑郁症的简短行为激活(BA)治疗所提供的治疗。Moodivate是设计的 特别是为了解决通过初级保健进行可传播的、基于证据的抑郁症治疗的需要。我们的 第一阶段STR成功地达到了所有目标，因此出版了两份治疗发展文件 和一份初步成果报告。具体到可行性和可接受性，70%的Moodivate参与者招募了 从初级保健中心下载一个月后继续使用该应用程序，下载两个月后50%的人使用该应用程序。 具体到疗效，Moodivate(与通常的治疗相比)导致抑郁症的下降幅度明显大于 时间，随着两个月的随访，治疗进展持续。尽管这些数据很有希望，但有几个 在Moodivate商业化之前，必须解决关键问题。首先，虽然最终用户和一个客户 因为Moodivate是患者，另一个客户是医疗保健系统。因此，Moodivate必须集成 使用医疗保健系统(即，使用电子健康记录(EHR))，以促进提供者转介和 监测治疗反应。其次，我们的经验表明，需要对产品进行细微的修改 在额外的临床试验和最终商业化之前。第三，向商业化迈进 并收集FDA批准可能需要的数据，需要进行更大规模的临床试验。第四，任何 医疗保健系统中Moodivate的下游商业化需要我们首先在财务方面进行量化 无论是作为一个独立的应用程序，还是作为与EHR集成的应用程序，它的成本效益都是如此。因此，这样做的目的是 第二阶段STTR将1)完善和开发EHR提供者门户，2)通过三臂随机 对照试验(N=600)，检查Moodivate与Moodivate+EHR联合治疗与AS治疗的疗效 通常用于初级保健中的抑郁症状的治疗，以及3)进行成本效益 量化基层医院实施Moodivate和Moodivate+EHR的财务效益分析 关心。第二阶段的研究活动与强大的商业化计划相结合，将共同推动我们的 该公司正在迈向第三阶段，并将满足以初级保健为基础的抑郁症治疗的公共卫生需求。

PROJECT SUMMARY/ABSTRACT Depression is the leading cause of disability worldwide, with more than 300 million people affected. Most adults with depressive symptoms make at least one annual visit to a primary care physician (PCP). As such, primary care offers a ripe opportunity to identify and treat adults with depressive symptomatology. Yet, depression has historically been undertreated in primary care, and more than two-thirds of U.S. adults who screen positive for depression do not receive treatment. Mobile health (mHealth) technologies, and specifically mobile apps, offer an ideal strategy to meet the need for evidence-based psychological treatment via primary care. Via our Phase I STTR, we developed and preliminarily clinically evaluated “Moodivate”, a self-help mobile app depression treatment informed by the Brief Behavioral Activation (BA) Treatment for Depression. Moodivate was designed specifically to address the need for disseminable, evidence-based depression treatment via primary care. Our Phase I STTR was successful in meeting all aims, resulting in publication of both a treatment development paper and a primary outcomes paper. Specific to feasibility and acceptability, 70% of Moodivate participants recruited from primary care continued to use the app one month after download and 50% two months after download. Specific to efficacy, Moodivate (vs. treatment as usual) led to significantly greater decreases in depression over time, with treatment gains sustained over two-months of follow-up. Although these data are promising, several key issues must be resolved before Moodivate commercialization. First, although the end user and one customer for Moodivate is the patient, an additional customer is the healthcare system. Thus, Moodivate must be integrated with the healthcare system (i.e., with the Electronic Health Record (EHR)) to facilitate provider referral and monitoring of treatment response. Second, our experience shows that minor product modifications are needed prior to additional clinical testing and eventual commercialization. Third, to advance toward commercialization and collect data potentially necessary for FDA approval, a larger-scale clinical trial is needed. Fourth, any downstream commercialization of Moodivate within healthcare systems requires that we first quantify in financial terms its cost-effectiveness, both as a stand-alone app and as integrated with the EHR. Thus, the Aims of this Phase II STTR are to 1) Refine Moodivate and develop the EHR provider portal, 2) Via a three-arm randomized controlled trial (N=600), examine the efficacy of Moodivate vs. Moodivate + EHR integration vs. treatment as usual for the treatment of depressive symptoms within primary care, and 3) Conduct a cost-effectiveness analysis to quantify the financial benefits of Moodivate and Moodivate + EHR implementation within primary care. Phase II research activities are coupled with a strong commercialization plan which together will propel our company toward Phase III and will address the public health need for primary care-based depression treatment.