DepressionDepWatchNCT06292221
Personalized Depression Treatment Supported by Mobile Sensor Analytics
A study testing A mobile Health (mHealth) tool called 'DepWatch' in people with Depression, run by UConn Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression
- What is being tested?
- A mobile Health (mHealth) tool called 'DepWatch'
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 8 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Smart and Connected Health: 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:
- 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.
- Conditions
- Depression
- Being tested
- A mobile Health (mHealth) tool called 'DepWatch'
- Keywords
- Depression, smartphone
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: A mobile Health (mHealth) tool called 'DepWatch' |
| Control | Other | For this group of participants: The study clinicians will NOT receive the weekly depression and behavioral assessment reports generated by the mHealth tool 'DepWatch' Receives: Other: A mobile Health (mHealth) tool called 'DepWatch' |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 surveys conducted 4 months apart (over the 12 month study period)
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start4 Apr 2024
- Primary completion8 Jun 2025
- Study completion8 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of participants (64 per group) will be enrolled and will participate in the study over a 3 month period . Both will receive standard of care depression treatment with their respective providers in the clinic. Both groups will undergo standard depression assessment using depression questionnaires as well as behavioral assessments using a mobile health (mHealth) tool 'DepWatch' developed by the study team in the phase I of the study. Study clinicians will receive weekly behavioral assessment reports for participants enrolled in the first 'experimental' group and will not receive such reports for the second 'control' group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Bing Wang, University of Connecticut
- Investigators
- Jayesh Kamath, MD PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292221
- Sponsor's protocol ID
- H19-078
- Other IDs
- R01MH119678
- Acronym
- DepWatch
- Status last verified
- Jul 2025
- First submitted
- 27 Feb 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As per our data sharing plan: Aggregate data will be shared
Publications
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.
PubMed 32529036
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart and Connected Health: Personalized Depression Treatment Supported by Mobile Sensor Analytics
- ClinicalTrials.gov ID
- NCT06292221
- Acronym / sponsor ID
- DepWatch / H19-078
- Conditions
- Depression
- Keywords
- Depression, smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 8 Jun 2025 (actual)
- Study completion
- 8 Jun 2025 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of participants (64 per group) will be enrolled and will participate in the study over a 3 month period . Both will receive standard of care depression treatment with their respective providers in the clinic. Both groups will undergo standard depression assessment using depression questionnaires as well as behavioral assessments using a mobile health (mHealth) tool 'DepWatch' developed by the study team in the phase I of the study. Study clinicians will receive weekly behavioral assessment reports for participants enrolled in the first 'experimental' group and will not receive such reports for the second 'control' group
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: A mobile Health (mHealth) tool called 'DepWatch'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 |
| Control | Other | Other: A mobile Health (mHealth) tool called 'DepWatch'For this group of participants: The study clinicians will NOT receive the weekly depression and behavioral assessment reports generated by the mHealth tool 'DepWatch' |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, Experimental |
Primary outcome
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
1 secondary outcome
Depression outcomes
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 32529036Kamath 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.
- Individual participant dataSharing planned: No. As per our data sharing plan: Aggregate data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayesh Kamath, MD PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A mobile Health (mHealth) tool called 'DepWatch' in people with Depression, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Usability (time frame: 3 surveys conducted 4 months apart (over the 12 month study period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06292221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.