A Mobile Behavioral Monitoring Intervention for Bipolar Disorder

描述（由申请人提供）：这项R34研究将开发和试点双相情感障碍的智能手机干预。背景：双相情感障碍是一种严重的慢性精神疾病，可增加死亡率并极大地损害功能。心理社会疗法与药物治疗相结合可以改善治疗结果，但获得心理社会干预的机会有限，只有一半的双相情感障碍患者接受心理社会干预。目前的疗法还在以下方面具有局限性：1）依赖于主观患者报告和2）难以识别即将发作的警告信号。此外，尽管睡眠和活动的改变是双相情感障碍的核心症状，但对可观察到的日常行为模式的直接测量并不常见。意义：该项目将开发一种用于双相情感障碍的智能手机干预，这将增加获得心理社会干预的机会。电话的使用将允许向患者和提供者提供常规反馈， 手机收集的行为数据。这将增强患者对其症状的自我管理并改善治疗结果。创新：1）使用智能手机使患者在日常生活中随时可以获得心理社会干预。2)使用 腕戴式活动计与电话通信以提供与症状状态相关的活动数据的一致收集。3)使用电话收集与症状状态相关的新位置和社交互动数据。4)利用行为数据反馈来提高患者症状自我管理，并告知提供者改善治疗的评估和针对性。初步研究：研究小组的成员已经开发出基于活动测量数据对患者进行分层的算法，并使用移动的手机来测量生命空间，这可能会在抑郁症期间减少，在躁狂症期间扩大。该系统的快速成功开发将通过与行为干预技术中心的合作来促进，该中心在通过智能手机开发和提供有效的心理干预方面拥有丰富的专业知识。设计：迭代的、以用户为中心的设计过程将提高患者和提供者的接受度、参与度和长期系统使用。一项小型随机对照试验将测试研究方案（系统、招募、对照、评估）的可行性，为更大规模的随机对照试验做准备。人口：目前处于缓解期的成人双相情感障碍患者，在过去两年中有两次急性发作史，正在接受常规治疗。结果：研究方案的所有方面都将在后续随机对照试验的准备中实施。将评估系统使用、可用性和满意度的标记。大型研究的主要结局将是出现症状的时间百分比。次要结果将包括复发时间、症状严重程度和生活质量。

DESCRIPTION (provided by applicant): This R34 study will develop and pilot a smartphone intervention for bipolar disorder. Background: Bipolar disorder is a severe and chronic mental illness that increases mortality and greatly impairs functioning. Psychosocial therapies in combination with medication improve treatment outcomes, but access to psychosocial interventions is limited and only half of bipolar patients receive them. Current therapies also have limitations in terms of: 1) reliance on subjective patient report and 2) difficulties in identifying warning signs of impending episodes. Furthermore, direct measurement of observable daily patterns of behavior is not routinely available, even though alterations in sleep and activity are core symptoms of bipolar disorder. Significance: This project will develop a smartphone intervention for bipolar disorder that will increase access to psychosocial interventions. The use of the phone will allow routine feedback to patients and providers utilizing behavioral data collected by the phone. This should enhance patient self-management of their symptoms and improve treatment outcomes. Innovation: 1) Use of a smartphone to make psychosocial interventions readily accessible to patients during their day-to-day life. 2) Use of a wrist-worn actimeter communicating with the phone to provide consistent collection of activity data relevant to symptom status. 3) Use of the phone to collect novel location and social interaction data relevant to symptom status. 4) Utilizing behavioral data feedback to increase patient symptom self-management and to inform providers for improved evaluation and targeting of treatment. Preliminary studies: Members of the research team have developed algorithms for stratifying patients based on actimetry data and have used mobile phones to measure lifespace which might decrease during depression and expand during mania. The rapid successful development of the system will be facilitated by collaborating with the Center for Behavioral Intervention Technologies, which has substantial expertise in developing and delivering effective psychosocial interventions via smartphones. Design: An iterative, user-centered design process will increase acceptance, participation, and long-term system use by patients and providers. A small randomized controlled trial will test the feasibility of the study protocol (system, recruitment, control, assessment) in preparation for a larger randomized controlled trail. Population: Adult bipolar disorder patients in current remission with a history o two acute episodes in the last two years who are in routine treatment. Outcomes: All aspects of the study protocol will be operationalized in preparation for the subsequent randomized controlled trial. Markers of system use, usability, and satisfaction will be assessed. The primary outcome piloted for the larger study will be percent time symptomatic. Secondary outcomes will include time to relapse, symptom severity, and quality of life.