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

针对抑郁症状加重的行为激活移动疗法的开发和测试

基本信息

批准号：
10006356
负责人：
Jennifer Renee Dahne
金额：
$ 74.97万
依托单位：
MOUNTAINPASS TECHNOLOGY, LLC
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-01 至 2023-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10006356
关键词：
Address Adult Advisory Committees Affect Android Antidepressive Agents Behavioral Caring Clinical Clinical Trials Complex Cost Effectiveness Analysis Coupled Data Derivation procedure Development Electronic Health Record Feedback Focus Groups Goals Health Health Insurance Portability and Accountability Act Health Technology Healthcare Healthcare Systems Mental Depression Mental Health Minor Modification Monitor Morbidity - disease rate Movement National Institute of Mental Health Occupational Outcome Paper Participant Patient Preferences Patient Recruitments Patient Self-Report Patients Pharmaceutical Preparations Phase Physicians Positioning Attribute Preventive service Primary Care Physician Primary Health Care Provider Public Health Publications Randomized Controlled Trials Reporting Research Research Activity Small Business Technology Transfer Research Testing Time United States Visit arm base care delivery clinical efficacy commercialization cost cost effectiveness depressive symptoms design digital disability evidence base experience follow-up improved incremental cost-effectiveness mHealth meetings mobile application mortality primary outcome psychologic research clinical testing routine practice self help single episode major depressive disorder social symptomatology technology development therapeutic development therapy development tool traditional care treatment as usual treatment response usability

项目摘要

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.

项目概要/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。患有抑郁症状的患者每年至少去看一次初级保健医生 (PCP)。护理为识别和治疗患有抑郁症状的成年人提供了成熟的机会。历史上初级保健中的治疗不足，超过三分之二的美国成年人筛查呈阳性移动健康 (mHealth) 技术，特别是移动应用程序无法提供抑郁症治疗。通过我们的阶段满足基于证据的心理治疗需求的理想策略。 I STTR，我们开发并初步临床评估了一款抑郁症自助移动应用程序“Moodivate” Moodivate 的简短行为激活 (BA) 治疗方案是设计的治疗方法。特别是为了满足通过初级保健进行可传播的、基于证据的抑郁症治疗的需求。第一阶段 STTR 成功实现了所有目标，发表了治疗开发论文针对可行性和可接受性，招募了 70% 的 Moodivate 参与者。来自初级保健的 50% 的人在下载后 1 个月后继续使用该应用程序，50% 的人在下载两个月后继续使用该应用程序。具体到疗效方面，Moodivate（与常规治疗相比）使抑郁症显着降低。尽管这些数据令人鼓舞，但在两个月的随访中，治疗效果持续改善。 Moodivate商业化之前必须解决的关键问题第一，虽然最终用户和一个客户。 Moodivate 是患者，另一个客户是医疗保健系统，因此必须集成 Moodivate。与医疗保健系统（即电子健康记录 (EHR)）合作，以方便提供者转介和其次，我们的经验表明，需要对产品进行细微的修改。在进行额外的临床测试和最终商业化之前第三，推进商业化。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。 Moodivate 在医疗保健系统内的下游商业化要求我们首先在财务方面进行量化其成本效益，无论是作为独立的应用程序还是与 EHR 集成，因此，其目标是。第二阶段 STTR 将 1) 完善 Moodivate 并开发 EHR 提供商门户，2) 通过三臂随机对照试验 (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治疗抑郁症状，以及 3) 进行成本效益评估分析以量化 Moodivate 和 Moodivate + EHR 在基层实施的经济效益第二阶段的研究活动与强大的商业化计划相结合，共同推动我们的发展。公司正迈向第三阶段，并将满足基于初级保健的抑郁症治疗的公共卫生需求。