Links between self-monitoring data collected through smartphones and smartwatches and the individual disease trajectories of adult patients with depressive disorders: Study protocol of a one-year observational trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-05-10 DOI:10.1016/j.conctc.2025.101492

Hanna Reich , Simon Schreynemackers , Rebeka Amin , Sascha Ludwig , Jil Zippelius , Johannes Leimhofer , Tobias Dunker , Elisabeth Schriewer , Angela Carell , Yvonne Weber , Ulrich Hegerl , the MONDY consortium

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引用次数: 0

Abstract

Depression is highly recurrent and heterogenous in its individual course, requiring a personalized treatment approach. Patients today can collect large volumes of personal data via smartphones and smartwatches and may utilize them for their treatment and self-management. We aim to provide proof-of-concept that these data can (i) serve as an objective marker of and (ii) predict the daily and weekly self-reported depression severity within individuals with depressive disorders.

In this exploratory study, 15 adult patients with depressive disorders will collect self-report and biosensor data over the course of one year. Participants will (a) attend three in-person appointments (at baseline, 6 months, and 12 months), (b) self-report daily and weekly depressive symptoms, (c) continuously collect sensor data via the “iTrackDepression” app on their Android smartphone (app usage, phone calls, phonetic parameters from voice recordings), and (d) wear a Samsung Galaxy Watch 5® to record data from the accelerometer, step sensor, light sensor, and heart rate sensor. We will apply multilevel correlations, vector-autoregressive models, and Machine Learning approaches to identify individual patterns in the data, particularly in the relationships between biosensor data and self-reported depressive symptoms.

Enhancing the understanding of individual disease trajectories through data from smartphones and smartwatches could allow for classical, digital, and self-management interventions for depression to be delivered in a manner and at a time specifically tailored to the individual's needs.

Clinical trial registration number: DRKS00032618 (https://drks.de/search/en/trial/DRKS00032618)

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通过智能手机和智能手表收集的自我监测数据与成年抑郁症患者个体疾病轨迹之间的联系：一项为期一年的观察性试验的研究方案

抑郁症在其个体病程中是高度复发和异质性的，需要个性化的治疗方法。如今，患者可以通过智能手机和智能手表收集大量个人数据，并可能将其用于治疗和自我管理。我们的目标是提供概念证明，这些数据可以(i)作为客观标记，（ii）预测抑郁症患者每日和每周自我报告的抑郁严重程度。在这项探索性研究中，15名成年抑郁症患者将在一年的时间里收集自我报告和生物传感器数据。参与者将(a)参加三次面对面的预约（基线、6个月和12个月），(b)自我报告每日和每周的抑郁症状，(c)通过Android智能手机上的“iTrackDepression”应用程序持续收集传感器数据（应用程序使用情况、电话通话、语音记录的语音参数），以及(d)佩戴三星Galaxy Watch 5®记录加速度计、步进传感器、光传感器和心率传感器的数据。我们将应用多层次关联、向量自回归模型和机器学习方法来识别数据中的个体模式，特别是生物传感器数据与自我报告的抑郁症状之间的关系。通过智能手机和智能手表的数据加强对个体疾病轨迹的理解，可以根据个人需求在特定的时间和方式提供经典的、数字化的和自我管理的抑郁症干预措施。临床试验注册号：DRKS00032618 （https://drks.de/search/en/trial/DRKS00032618）

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.