Dargél Aroldo A, Mosconi Elise, Masson Marc, Plaze Marion, Taieb Fabien, Von Platen Cassandra, Buivan Tan Phuc, Pouleriguen Guillaume, Sanchez Marie, Fournier Stéphane, Lledo Pierre-Marie, Henry Chantal
Perception and Memory Unit, Neuroscience Department, Pasteur Institute, Paris, France.
Unité Mixte de Recherche 3571, Centre National de la Recherche Scientifique (CNRS), Paris, France.
JMIR Res Protoc. 2020 Aug 18;9(8):e18818. doi: 10.2196/18818.
The diagnosis and management of bipolar disorder are limited by the absence of available biomarkers. Patients with bipolar disorder frequently present with mood instability even during remission, which is likely associated with the risk of relapse, impaired functioning, and suicidal behavior, indicating that the illness is active.
This research protocol aimed to investigate the correlations between clinically rated mood symptoms and mood/behavioral data automatically collected using the Toi Même app in patients with bipolar disorder presenting with different mood episodes. This study also aimed to assess the feasibility of this app for self-monitoring subjective and objective mood/behavior parameters in those patients.
This open-label, nonrandomized trial will enroll 93 (31 depressive, 31 euthymic, and 31 hypomanic) adults diagnosed with bipolar disorder type I/II (Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria) and owning an iPhone. Clinical evaluations will be performed by psychiatrists at the baseline and after 2 weeks, 1 month, 2 months, and 3 months during the follow-up. Rather than only accessing the daily mood symptoms, the Toi Même app also integrates ecological momentary assessments through 2 gamified tests to assess cognition speed (QUiCKBRAIN) and affective responses (PLAYiMOTIONS) in real-life contexts, continuously measures daily motor activities (eg, number of steps, distance) using the smartphone's motion sensors, and performs a comprehensive weekly assessment.
Recruitment began in April 2018 and the completion of the study is estimated to be in December 2021. As of April 2019, 25 participants were enrolled in the study. The first results are expected to be submitted for publication in 2020. This project has been funded by the Perception and Memory Unit of the Pasteur Institute (Paris) and it has received the final ethical/research approvals in April 2018 (ID-RCB: 2017-A02450-53).
Our results will add to the evidence of exploring other alternatives toward a more integrated approach in the management of bipolar disorder, including digital phenotyping, to develop an ethical and clinically meaningful framework for investigating, diagnosing, and treating individuals at risk of developing bipolar disorder or currently experiencing bipolar disorder. Further prospective studies on the validity of automatically generated smartphone data are needed for better understanding the longitudinal pattern of mood instability in bipolar disorder as well as to establish the reliability, efficacy, and cost-effectiveness of such an app intervention for patients with bipolar disorder.
ClinicalTrials.gov NCT03508427; https://clinicaltrials.gov/ct2/show/NCT03508427.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18818.
双相情感障碍的诊断和管理因缺乏可用的生物标志物而受到限制。双相情感障碍患者即使在缓解期也经常出现情绪不稳定，这可能与复发风险、功能受损和自杀行为有关，表明疾病仍处于活动状态。
本研究方案旨在调查双相情感障碍患者在不同情绪发作期，临床评定的情绪症状与使用Toi Même应用程序自动收集的情绪/行为数据之间的相关性。本研究还旨在评估该应用程序对这些患者自我监测主观和客观情绪/行为参数的可行性。
这项开放标签、非随机试验将招募93名（31名抑郁发作期、31名心境正常期、31名轻躁狂发作期）被诊断为I/II型双相情感障碍（依据《精神疾病诊断与统计手册》第5版标准）且拥有iPhone的成年人。在基线以及随访期间的第2周、1个月、2个月和3个月，由精神科医生进行临床评估。Toi Même应用程序不仅可以获取每日情绪症状，还通过两项游戏化测试整合生态瞬时评估，以在现实生活情境中评估认知速度（QUiCKBRAIN）和情感反应（PLAYiMOTIONS），使用智能手机的运动传感器持续测量每日运动活动（如步数、距离），并进行每周一次的全面评估。
招募工作于2018年4月开始，预计研究在2021年12月完成。截至2019年4月，已有25名参与者入组。预计2020年提交首批研究结果以供发表。该项目由巴斯德研究所（巴黎）的感知与记忆部门资助，并于2018年4月获得最终伦理/研究批准（ID-RCB：2017-A02450-53）。
我们的研究结果将为探索双相情感障碍管理中更综合方法的其他替代方案提供证据，包括数字表型分析，从而建立一个用于调查、诊断和治疗有双相情感障碍风险或正在经历双相情感障碍的个体的伦理且具有临床意义的框架。需要对自动生成的智能手机数据的有效性进行进一步的前瞻性研究，以更好地了解双相情感障碍患者情绪不稳定的纵向模式，并确定此类应用程序干预对双相情感障碍患者的可靠性、有效性和成本效益。
ClinicalTrials.gov NCT03508427；https://clinicaltrials.gov/ct2/show/NCT03508427。
国际注册报告识别码（IRRID）：DERR1-10.2196/18818。
