Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression

July 16, 2018 updated by: Cogito Health Inc
The purpose of this study is to determine if a mobile sensing platform can passively and objectively detect the presence of clinically significant mood disorder symptomatology and symptom progression over time. Meeting this goal will allow for improved risk categorization, prediction of relapse, and measurement of disease progression in a lifetime prevalence population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

899

Contacts and Locations

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

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be selected from the MoodNetwork, an online network of individuals with mood disorders, which is hosted by MGH. A subset of participants with mood disorders enrolled in MoodNetwork will download Cogito's mobile sensing platform on their mobile phones.

Description

Inclusion Criteria:

  • Age 18 or older
  • Have a smartphone and cell service plan, including voice and data, that meets the device requirements of the Mobile Sensing Platform.
  • Enrolled in the MoodNetwork

Exclusion Criteria:

  • Report positively on the QIDS-SR suicide item during study intake
  • Total score greater than 15 on the QIDS-SR during the screening process

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MDD-Single Episode
1. Subjects who have experienced 1 episode of major depressive disorder (MDD) in their lifetime.
Other: Cogito Companion Mobile Phone Application
Other Names:
  • Cogito Mobile Sensing Platform
MDD-Recurrent
1. Subjects who have experienced 2 or more episodes of depressive disorder (MDD) in their lifetime.
Other: Cogito Companion Mobile Phone Application
Other Names:
  • Cogito Mobile Sensing Platform
Bipolar Disorder
1. Subjects who have been diagnosed with bipolar disorder in their lifetime.
Other: Cogito Companion Mobile Phone Application
Other Names:
  • Cogito Mobile Sensing Platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity of MDD symptoms as assessed by QIDS SR
Time Frame: 6 months
6 months
Severity of Mania symptoms as assessed by ASRM
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Cogito Health Inc

Collaborators

Massachusetts General Hospital
Partners HealthCare

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

February 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R44MH107065-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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