Clinical trial NCT04358900: Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics (UnMASCK)
Official title: Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mood Disorders
Major Depressive Disorder
Bipolar Disorder I
Bipolar Disorder II
Persistent Depressive Disorder (Dysthymia)
Cyclothymia
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-04-24
Enrollment: 132
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Neuroimaging
timeFrame: Change from week 2 to week 4.
measure: BiAffect Metric
timeFrame: Measured at the end of week 4 after using the BiAffect app for 4 weeks
measure: Clinical symptoms
timeFrame: Measured at baseline.
measure: Cognition
timeFrame: Change from week 2 to week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Olusola Ajilore, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: