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临床试验/NCT06292221
NCT06292221已完成不适用

Smart and Connected Health: Personalized Depression Treatment Supported by Mobile Sensor Analytics

UConn Health2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Feasibility and Usability

研究概览

简要总结

The current best practice guidelines for treating depression call for close monitoring of patients, and periodically adjusting treatment as needed. This present study seeks to develop and investigate an innovative digital system, DepWatch, that leverages mobile health technologies and machine learning tools to provide clinicians objective, accurate, and timely assessment of depression symptoms to assist with their clinical decision making process. Specifically, DepWatch collects sensory data passively from smartphones and wristbands, without any user interaction, and uses simple user-friendly interfaces to collect ecological momentary assessments (EMA), medication adherence and safety related data from patients. The collected data will be fed to machine learning models to be developed in the project to provide weekly assessment of patient symptom levels and predict the trajectory of treatment response over time. The assessment and prediction results are then presented using a graphic interface to clinicians to help them make critical treatment decisions. The main question the present clinical trial aims to answer are as follows:

  1. Feasibility of the digital tool, DepWatch, to assist clinicians in depression treatment and inform their clinical decision process
  2. Effectiveness of the digital tool, DepWatch, to improve depression treatment outcomes All study participants will carry the DepWatch app on their smartphones and wear a Fitbit provided by the study team during the study period. They will also complete brief questionnaires via the app at specific time intervals throughout the study period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

盲法说明

There is no masking

入排标准

性别
All
接受健康志愿者

入选标准

  • Age 18 year or older
  • Moderate level of depression as defined by a score of ≥ 11 on the 16 item Quick Inventory of Depressive Symptomatology (QIDS) self-report questionnaire
  • Initiating a pharmacological treatment for depression as monotherapy or adjunctive treatment or reporting a dose increase with their existing depression treatment.

排除标准

  • Diagnosis of a primary psychotic disorder such as schizophrenia or schizoaffective disorder
  • Currently active substance use disorder (within 1 month of enrollment) dominating clinical scenario
  • Other clinically significant medical of psychiatric conditions that may adversely affect participants' study participation and/or affect their adherence to study protocol (as determined by study clinician) e.g., significant cognitive deficits

结局指标

主要结局

Feasibility and Usability

时间窗: 3 surveys conducted 4 months apart (over the 12 month study period)

Study clinicians will complete surveys about feasibility and usability of the weekly. assessments provided to them on their patients in informing their clinical decision making process

次要结局

  • Depression outcomes(3 months)

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bing Wang

Professor

University of Connecticut

研究点 (2)

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