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OpenTrials
Completed

NCT Number: NCT06292221

Personalized Depression Treatment Supported by Mobile Sensor Analytics

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

A mobile Health (mHealth) tool called 'DepWatch'

Other

The mobile Health (mHealth) tool 'DepWatch' developed by the study team consists of the DepWatch app that is uploaded on participant's smart phones with their consent and a Fitbit provided to the participants

Primary outcomes

  1. Feasibility and Usability

    Time frame: 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

Secondary outcomes

  1. Depression outcomes

    Time frame: 3 months

    Depression outcomes will be compared between the two groups using the 'Quick Inventory of Depression Symptomatology' questionnaire. Quick Inventory of Depression Symptomatology (self-report), minimum value 0, maximum value 27, Higher scores mean worse outcome.

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: DepWatch

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2024
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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