Predicting Recurrences in Bipolar Illness (Prompt-BD)

预测双相情感障碍的复发 (Prompt-BD)

• 批准号: 10474530
• 负责人: BORIS BIRMAHER
• 金额: $ 74.55万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10474530
• 关键词: Accelerometer; Address; Adolescent; Adult; Age; Behavior; Biological; Bipolar Disorder; Cellular Phone; Clinical; Clinical Research; Clinical assessments; Communication; Conflict (Psychology); Counseling; Data; Detection; Development; Discrimination; Disease remission; Distal; Early Diagnosis; Evaluation; Family; Family history of; Future; Gold; Grain; Individual; Intake; Intervention; Manic; Maps; Mathematics; Measures; Medicine; Mental Depression; Methods; Modeling; Monitor; Moods; Outcome; Participant; Patient Participation; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Problem behavior; Prognosis; Questionnaires; Recurrence; Recurrence Score; Research; Risk; Risk Factors; Sampling; Sleep; Sleep disturbances; Social Interaction; Substance abuse problem; Suicide; Telephone; Testing; Text Messaging; Time; Youth; actigraphy; aged; base; behavior change; clinical practice; clinical predictors; digital; early adolescence; emerging adult; follow-up; improved; improved functioning; individualized medicine; instrument; interest; mood symptom; prevent; psychosocial; recruit; risk prediction; sex; smartphone Application; suicidal risk; time use; tool; young adult

With each recurrence, the prognosis for Bipolar Disorder (BD) worsens and the risk for suicidality and substance abuse increases, indicating the need to identify and manage the factors associated with recurrence risk. Factors associated with recurrence risk for the group as a whole have been identified, however, the question of how to predict recurrence risk for an individual with BD remains unanswered. Since the course of BD is heterogenous, the ability to predict recurrence risk at the person level would allow treatment to be tailored to the specific individual. As in other fields of medicine, we developed a risk calculator (RC) that predicts with approximately 80% discrimination the 1-5 year risk of any mood recurrence and the polarity of the recurrence in youths/young adults with BD. Given that the RC must be externally validated before it can reliably be used in clinical practice, the Predicting Recurrence of Mood in Patients with BD (PROMPT-BD) study proposes to externally validate the RC in BD youth/young adults. The existing RC (termed “distal” RC) is valuable, but only predicts long-term (1-5 year) recurrence risk and not proximal risk (i.e.1-4 weeks). Predicting proximal risk could enable prompt intervention upon detection of “warning” signs, potentially improving the course of BD. To do this, factors associated with impending recurrences in BD such as sleep-activity rhythms, mobility, and digital social interactions will be measured continuously in real-time using smartphone passive sensing and subsequently combined with clinical predictors from the distal RC to further enhance prediction. In contrast to self-reports, passive sensing can assess continuous changes in behavior over extended periods without requiring participant input. While actigraphy is the “gold standard” for assessment of sleep-activity rhythms, it is not feasible for participants to wear a research-grade activity monitor for the duration necessary for risk prediction of mood recurrences. Thus, we will examine how passive sensing-based assessments of sleep-activity data map onto actigraphy by collecting actigraphy data for five 2-week periods over follow-up (intake and at each follow-up). We will also explore if development and sex influence passive sensing measures of interest. To carry out this proposal, 120 BDI/II individuals (14-25 years old) who are currently in remission will be recruited. Clinical assessments will be administered at intake and 6,12,18, and 24-months. Sleep-activity rhythms (e.g. phone usage, accelerometer), mobility (e.g., GPS), and digital social interaction (e.g. phone communication log), will be continuously evaluated via smartphone passive sensing, yielding over 300 days of data per participant (>30,000 days combined across the sample). Finally, to more precisely identify the timing of recurrence and to temporally anchor retrospective mood assessments, participants will complete a brief weekly questionnaire for mood prompted via text message. PROMPT-BD findings will be instrumental in counseling patients and their families regarding proximal risk for recurrence and long-term prognosis and have great promise for informing the future development of individualized treatments and both clinical and biological studies.

随着每次复发，双相情感障碍（BD）的预后以及自杀和物质依赖的风险 滥用行为增加，表明需要查明和管理与复发风险有关的因素。因素 已经确定了与整个组的复发风险相关的风险，但是，如何 预测BD患者的复发风险仍然没有答案。由于BD的病程是异质性的， 在个人水平上预测复发风险的能力将使治疗能够针对特定的 单独的.与其他医学领域一样，我们开发了一个风险计算器（RC）， 80%区分1-5年任何情绪复发的风险和青年/青年复发的极性 成人BD考虑到RC必须经过外部验证才能可靠地用于临床实践， 预测BD患者情绪复发（PROMPT-BD）研究建议从外部验证 BD青年/年轻成人中的RC。现有的RC（称为“远端”RC）是有价值的，但仅预测长期（1-5 年）复发风险，而不是近端风险（即1 -4周）。预测近端风险可以及时 在检测到“警告”信号时进行干预，可能改善BD的进程。为此，因素 与BD即将复发相关，如睡眠-活动节律，移动性和数字社交 将使用智能手机被动传感持续实时测量相互作用， 与远端RC的临床预测因子结合，以进一步增强预测。与自我报告相反， 被动传感可以评估长期行为的连续变化，而不需要参与者 输入.虽然体动记录仪是评估睡眠-活动节律的“金标准”，但它不适用于 参与者佩戴研究级活动监测器，持续时间为情绪风险预测所需 复发。因此，我们将研究基于被动感知的睡眠活动数据评估如何映射到 通过在随访期间收集5个2周期的体动记录数据（摄入和每次随访时）进行体动记录。 我们还将探讨发展和性别是否会影响感兴趣的被动感知措施。开展这项 根据一项建议，将招募120名目前处于缓解期的BDI/II个体（14-25岁）。临床 将在入组和6、12、18和24个月时进行评估。睡眠活动节律（例如，电话 使用，加速度计），移动性（例如，GPS）和数字社交互动（例如电话通信日志），将 通过智能手机被动传感进行持续评估，每位参与者可获得超过300天的数据 （超过30，000天的样本）。最后，为了更精确地确定复发的时间， 暂时锚回顾性情绪评估，参与者将完成一份简短的每周问卷， 通过短信提示心情。PROMPT-BD研究结果将有助于咨询患者及其 家庭关于复发和长期预后的近端风险，并有很大的希望告知 个体化治疗以及临床和生物学研究的未来发展。