Personalized Depression Treatment Supported by Mobile Sensor Analytics

Depression Clinical Trial

— DepWatch  

Official title:

SCH: Personalized Depression Treatment Supported by Mobile Sensor Analytics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06292221
• Other study ID #: H19-078
• Secondary ID: R01MH119678
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: UConn Health
• Contact: Galina Prpich, MS
• Phone: 8606797539
• Email: prpich[@]uchc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: June 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kamath J, Bi J, Russell A, Wang B. Grant Report on SCH: Personalized Depression Treatment Supported by Mobile Sensor Analytics. J Psychiatr Brain Sci. 2020;5:e200010. doi: 10.20900/jpbs.20200010. Epub 2020 Apr 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and Usability	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	Depression outcomes	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