Personalized Depression Treatment Supported by Mobile Sensor Analytics (DepWatch)

May 2, 2024 updated by: Bing Wang, UConn Health

SCH: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • University of Connecticut Health Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Winokur, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
For this group of participants: The study clinicians will receive the weekly depression and behavioral assessment reports generated by the mHealth tool 'DepWatch' via a secure clinician portal
Other: A mobile Health (mHealth) tool called 'DepWatch'
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
Other: Control
For this group of participants: The study clinicians will NOT receive the weekly depression and behavioral assessment reports generated by the mHealth tool 'DepWatch'
Other: A mobile Health (mHealth) tool called 'DepWatch'
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 surveys conducted 4 months apart (over the 12 month study period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Jayesh Kamath, MD PhD, UConn Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H19-078
  • R01MH119678 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As per our data sharing plan: Aggregate data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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