Smart and Connected Health: Personalized Depression Treatment Supported by Mobile Sensor Analytics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Feasibility and Usability
Study Overview
Brief 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:
- Feasibility of the digital tool, DepWatch, to assist clinicians in depression treatment and inform their clinical decision process
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
There is no masking
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: A mobile Health (mHealth) tool called 'DepWatch' (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'
Intervention: A mobile Health (mHealth) tool called 'DepWatch' (Other)
Outcomes
Primary Outcomes
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
- Depression outcomes(3 months)
Investigators
Bing Wang
Professor
University of Connecticut