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

项目总结/摘要 抑郁症是全球残疾的主要原因，有3亿多人受到影响。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 护理提供了一个成熟的机会，以确定和治疗成人抑郁症。然而，抑郁症 历史上在初级保健中治疗不足，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。移动的健康（mHealth）技术，特别是移动的应用程序， 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 在STTR，我们开发并初步临床评估了“Moodivate”，一个自助移动的应用程序抑郁症 抑郁症的简短行为激活（BA）治疗。Moodivate的设计 特别是通过初级保健来解决可传播的、基于证据的抑郁症治疗的需求。我们 I期STTR成功地达到了所有目标，发表了治疗开发论文， 和一份主要成果文件。具体到可行性和可接受性，70%的Moodivate参与者招募 在下载后一个月，50%的初级保健人员继续使用该应用程序，在下载后两个月，50%的人继续使用该应用程序。 具体到疗效，与常规治疗相比， 时间，治疗收益持续超过两个月的随访。虽然这些数据很有希望，但 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 对于Moodivate来说，病人是一个额外的客户，医疗保健系统是一个额外的客户。因此，Moodivate必须整合 对于医疗保健系统（即，与电子健康记录（EHR）），以方便提供者转诊， 监测治疗反应。第二，我们的经验表明，需要对产品进行微小的修改 在进一步的临床试验和最终的商业化之前。第三，向商业化迈进 并收集可能需要FDA批准的数据，需要更大规模的临床试验。第四，任何 Moodivate在医疗保健系统中的下游商业化要求我们首先在财务方面进行量化， 就其成本效益而言，无论是作为一个独立的应用程序，还是与EHR集成。因此， 第二阶段STTR是1）完善Moodivate并开发EHR提供者门户，2）通过三组随机 对照试验（N=600），检查Moodivate与Moodivate + EHR整合与治疗的疗效， 通常用于初级保健中的抑郁症状治疗，以及3）进行成本效益分析 分析，以量化在小学内实施Moodivate和Moodivate + EHR的财务效益 在乎第二阶段的研究活动与一个强大的商业化计划相结合，这将共同推动我们的 公司走向第三阶段，并将解决公共卫生需要的初级保健为基础的抑郁症治疗。

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.