Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression
1 other identifier
observational
899
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedJuly 17, 2018
July 1, 2018
2.9 years
April 11, 2016
July 16, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Severity of MDD symptoms as assessed by QIDS SR
6 months
Severity of Mania symptoms as assessed by ASRM
6 months
Study Arms (3)
MDD-Single Episode
1\. Subjects who have experienced 1 episode of major depressive disorder (MDD) in their lifetime.
MDD-Recurrent
1\. Subjects who have experienced 2 or more episodes of depressive disorder (MDD) in their lifetime.
Bipolar Disorder
1\. Subjects who have been diagnosed with bipolar disorder in their lifetime.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Report positively on the QIDS-SR suicide item during study intake
- Total score greater than 15 on the QIDS-SR during the screening process
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cogito Health Inclead
- Massachusetts General Hospitalcollaborator
- Partners HealthCarecollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2016
First Posted
April 18, 2016
Study Start
February 1, 2015
Primary Completion
December 31, 2017
Study Completion
March 31, 2018
Last Updated
July 17, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share