Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics (UnMASCK) (UnMASCK)
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|ClinicalTrials.gov Identifier: NCT04358900|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : January 28, 2022
|Condition or disease|
|Mood Disorders Major Depressive Disorder Bipolar Disorder I Bipolar Disorder II Persistent Depressive Disorder (Dysthymia) Cyclothymia|
|Study Type :||Observational|
|Estimated Enrollment :||132 participants|
|Official Title:||Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics|
|Actual Study Start Date :||September 17, 2020|
|Estimated Primary Completion Date :||August 31, 2025|
|Estimated Study Completion Date :||August 31, 2025|
Mood disorder group
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.
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.
- Neuroimaging [ Time Frame: Change from week 2 to week 4. ]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.
- BiAffect Metric [ Time Frame: Measured at the end of week 4 after using the BiAffect app for 4 weeks ]
- 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.
- Clinical symptoms [ Time Frame: Measured at baseline. ]
- 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.
- Cognition [ Time Frame: Change from week 2 to week 4 ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04358900
|Contact: Olusola Ajilore, MD, PhD||(312) email@example.com|
|Principal Investigator:||Olusola Ajilore, MD, PhD||University of Illinois at Chicago|