Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics (UnMASCK)
Completed
Conditions studied: Mood Disorders, Major Depressive Disorder, Bipolar Disorder I, Bipolar Disorder II, Persistent Depressive Disorder (Dysthymia), Cyclothymia
In brief
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.
Key facts
- Study ID
- NCT04358900
- Run by
- University of Illinois at Chicago
- People needed
- 132
- Starts
- 2020-09-17
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2026-05-15
Who can join
Age: 25 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Illinois at Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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