Personalized Depression Treatment Supported by Mobile Sensor Analytics

Last updated: May 2, 2024
Sponsor: UConn Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

A mobile Health (mHealth) tool called 'DepWatch'

Clinical Study ID

NCT06292221
H19-078
R01MH119678
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 128
Treatment Group(s): 1
Primary Treatment: A mobile Health (mHealth) tool called 'DepWatch'
Phase:
Study Start date:
April 04, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • University of Connecticut Health Center

    Farmington, Connecticut 06030
    United States

    Active - Recruiting

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