CompletedNot Applicable

Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics (UnMASCK)

United States132 participantsStarted 2020-09-17

Plain-language summary

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.

Who can participate

Age range

25 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study tracked mood and cognition using smartphone keyboard patterns through an app called BiAffect — could you explain how that kind of passive monitoring might compare to the symptom tracking methods we're already using for my condition?
2Since this trial is completed, has any data or findings from it been published that you think are relevant to my diagnosis of a mood disorder, and could those findings change how you monitor my symptoms?
3The study combined keyboard dynamics with neuroimaging and cognitive testing — does that multimodal approach tell us anything new about how conditions like mine show up in everyday behavior, and is that something worth considering in my own care plan?
4Because this was a non-interventional monitoring study rather than a treatment trial, does it offer any real-world signals about early warning signs for mood episodes that my care team could act on?
5Are there any follow-up studies or tools coming out of this research that I might be eligible for, or that could give us a better way to track how my mood disorder is responding to treatment over time?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neuroimaging

Timeframe: Change from week 2 to week 4.

BiAffect Metric

Timeframe: Measured at the end of week 4 after using the BiAffect app for 4 weeks

Clinical symptoms

Timeframe: Measured at baseline.

Cognition

Timeframe: Change from week 2 to week 4

Trial details

NCT IDNCT04358900

SponsorUniversity of Illinois at Chicago

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Mood Disorders trials