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

Major Depressive Disorder Clinical Trial

— UnMASCK  

Official title:

Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04358900
• Other study ID #: 2019-1333
• Secondary ID: 1R01MH120168-01A
• Status: Recruiting
• Start date: September 17, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2023
• Source: University of Illinois at Chicago
• Contact: Olusola Ajilore, MD, PhD
• Phone: (312) 413-4562
• Email: oajilore[@]uic.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Affective Symptoms
• Bipolar Disorder
• Bipolar Disorder I
• Bipolar Disorder II
• Cyclothymia
• Cyclothymic Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Dysthymic Disorder
• Major Depressive Disorder
• Mood Disorders
• Persistent Depressive Disorder (Dysthymia)

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuroimaging	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.	Change from week 2 to week 4.
Primary	BiAffect Metric	BiAffect Metric component 1, Typing speed: Data collected through the keyboard provided by the BiAffect app to measure the Average Interkey Delay (The average time between keystrokes measured in seconds) and keys per second will be combined to report typing speed.; BiAffect Metric component 2, Backspace Ratio: Data collected through the keyboard provided by the BiAffect app to measure the number of backspace keypresses divided by total keypresses.; BiAffect Metric component 3, Autocorrect Rate: Data collected through the keyboard provided by the BiAffect app to measure the number of autocorrect events divided by total keypresses. These 3 components will be combined to report the BiAffect Metric.	Measured at the end of week 4 after using the BiAffect app for 4 weeks
Primary	Clinical symptoms	Severity of depressive symptoms: In person administration of the Inventory of Depressive Symptomatology (IDS-C/QIDS-C). Possible scores range from 0-111 where higher scores indicate more severe depression symptoms.; Symptoms of mania: In person administration of the Young Mania Rating Scale (YMRS) which has a total score range from 0 to 60; higher scores indicate a more severe mania.; Symptoms of depression: In person administration of the Hamilton Rating Scale for Depression (HAM-D). Scores range between 0-52, and the higher the score the more depressive symptoms a participant has. These questionnaires will be combined to produce the clinical symptoms measure.	Measured at baseline.
Primary	Cognition	Attention/ processing speed will be measured in person using the Flanker Inhibitory Control and Attention Test (scores range 0-5, and higher scores mean better attention), the Pattern Comparison Processing Speed Test (scores range 0-130, and higher scores mean faster processing speed), and the Trail Making Task part A (scores range 0-300 seconds, and lower scores mean faster processing speed).; Cognitive control will be measured in person using the Dimensional Change Card Sort Test (scores range 0-10, and higher scores mean better cognitive control), the Flanker Inhibitory Control and Attention Test, and the Trail Making Task part B (scores range 0-300 seconds, and lower scores mean higher cognitive control).; Working memory will be measured in person using the List Sorting Working Memory Test (scores range 0-28, and higher scores mean better working memory). Attention, cognitive control, and working memory scores will be combined to produce the cognitive outcome variable.	Change from week 2 to week 4