- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04358900
Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics (UnMASCK) (UnMASCK)
April 11, 2023 updated by: Olusola Alade Ajilore, University of Illinois at Chicago
Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics
Mood disorders are associated with significant financial and health costs for the United States, partially due to cognitive problems in these patients that can worsen disease course and impair treatment response.
This study proposes to use smartphone-based technology to monitor cognitive problems in patients with mood disorders by linking brain network changes with predicted worsening of mood symptoms.
The proposed study will provide evidence for using smartphone-based passive sensing as a cost-effective way to predict illness course and treatment response.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Anticipated)
132
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Olusola Ajilore, MD, PhD
- Phone Number: (312) 413-4562
- Email: oajilore@uic.edu
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois at Chicago
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Contact:
- Olusola Ajilore, MD, PhD
- Phone Number: 312-413-4562
- Email: oajilore@uic.edu
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Contact:
- Ellyn C Kennelly, BS
- Phone Number: (224)848-2917
- Email: ellynk@uic.edu
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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
23 years to 48 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The investigators will recruit 132 participants (100 with mood disorders, and 32 controls) from the Chicago area, psychiatry clinics at the UIC, and longitudinal studies of Dr. Langenecker (MH091811 and MH 101487).
All subjects will be recruited using community outreach efforts, not limited to but including listserv emails, flyers, word of mouth, and health fairs.
Description
Inclusion Criteria:
- 25-50 years, as age-related declines in brain connectivity occur starting around 40-45 years of age (49-51);
- Participants must meet criteria for one of the following disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 criteria (52): major depressive disorder (MDD), persistent depressive disorder (PDD), bipolar disorder (BD) type I/type II, cyclothymia. To ensure adequate representation across diagnostic categories (including controls), the investigators will cap enrollment of major mood disorders (MDD, BD type I/II) to 50%, PDD and cyclothymia to 25% and recruit a healthy comparison group to comprise the remaining 25% of the sample.
- Own a BiAffect-compatible smartphone.
Exclusion Criteria:
- Active suicidal ideation as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)(50), suicide attempt in the last 3 months
- Severe cognitive impairment secondary to a neurological disorder (mild cognitive impairment, neurocognitive disorders, traumatic brain injury, developmental delay)
- Active moderate or severe alcohol and/or substance use disorders;
- Major medical or neurologic illness that would interfere with protocol adherence and/or interpretation of findings; and
- Presence of contraindications to MRI.
- Pregnancy (positive pregnancy test), trying to become pregnant, or lactation.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Mood disorder group
Participants must meet criteria for one of the following disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 criteria (52): major depressive disorder (MDD), persistent depressive disorder (PDD), bipolar disorder (BD) type I/type II, cyclothymia.
Multiple mood disorders are employed, in line with the Research Domain Criteria (RDoC; (53)) framework and the relative imprecision of current symptom diagnostic clusters for tracking treatment responses and course of disease.
To ensure adequate representation across diagnostic categories (including controls), the investigators will cap enrollment of major mood disorders (MDD, BD type I/II) to 50%, PDD and cyclothymia to 25% and recruit a healthy comparison group to comprise the remaining 25% of the sample.
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Control group
Participants who do not meet the Diagnostic and Statistical Manual of Mental Disorders-5 criteria for (52): major depressive disorder (MDD), persistent depressive disorder (PDD), bipolar disorder (BD) type I/type II, or cyclothymia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuroimaging
Time Frame: Change from week 2 to week 4.
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a. Neuroimaging based biomarkers of cognitive performance will include Structural brain network Efficiency Interhemispheric Efficiency, Reduced nodal efficiency in ventrolateral prefrontal cortex/altered modularity, Reduced nodal efficiency in anterior cingulate cortex, and Reduced nodal efficiency in salience networks.
Neuroimaging will take place while the participant completes the parametric Go/No-go test completed during a functional magnetic resonance imaging after using BiAffect app for 2 weeks, and again after using the BiAffect app for 4 weeks.
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Change from week 2 to week 4.
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BiAffect Metric
Time Frame: Measured at the end of week 4 after using the BiAffect app for 4 weeks
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Measured at the end of week 4 after using the BiAffect app for 4 weeks
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Clinical symptoms
Time Frame: Measured at baseline.
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Measured at baseline.
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Cognition
Time Frame: Change from week 2 to week 4
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Change from week 2 to week 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Olusola Ajilore, MD, PhD, University of Illinois at Chicago
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 (Actual)
September 17, 2020
Primary Completion (Anticipated)
August 31, 2025
Study Completion (Anticipated)
August 31, 2025
Study Registration Dates
First Submitted
April 8, 2020
First Submitted That Met QC Criteria
April 20, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 11, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-1333
- 1R01MH120168-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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