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

University of Illinois

Status: Active, not recruiting

Conditions: Major Depressive Disorder; Bipolar Disorder I; Cyclothymia; Bipolar Disorder II; Persistent Depressive Disorder (Dysthymia); Mood Disorders

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04358900

2019-1333

1R01MH120168-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

132 participants in 2 patient groups

Mood disorder group

Description:

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.

Control group

Description:

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.