Mood DisordersUnMASCKNCT04358900

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

An observational study of Mood Disorders and Major Depressive Disorder, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Mood Disorders, Major Depressive Disorder, Bipolar Disorder I
How many people: 132 participants
Where: 1 siteUnited States
Study dates: 17 Sep 2020to 31 Dec 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 50 years
All sexes
Healthy volunteers accepted
Adult

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.

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

University of Illinois at Chicago
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics

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.

Conditions: Mood Disorders, Major Depressive Disorder, Bipolar Disorder I, Bipolar Disorder II, Persistent Depressive Disorder (Dysthymia), Cyclothymia
Medical subject headings: Mood Disorders, Depressive Disorder, Major, Bipolar Disorder, Dysthymic Disorder, Cyclothymic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04358900
Study group	Role	What they receive
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.
Control group		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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Neuroimaging
1. 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.
Measured: Change from week 2 to week 4.
BiAffect Metric
1. 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.
2. 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.
3. 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: Measured at the end of week 4 after using the BiAffect app for 4 weeks
Clinical symptoms
1. 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.
2. 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.
3. 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: Measured at baseline.
Cognition
1. 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).
2. 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).
3. 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.
Measured: Change from week 2 to week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 202031 Dec 2025

First posted24 Apr 2020
Study start17 Sep 2020
Primary completion31 Mar 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mood DisordersStudies of the same condition, open and under way.
More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04358900
Sponsor's protocol ID: 2019-1333
Other IDs: 1R01MH120168-01A1
Acronym: UnMASCK
Status last verified: May 2026
First submitted: 8 Apr 2020
Last updated: 15 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mood Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics
ClinicalTrials.gov ID: NCT04358900
Acronym / sponsor ID: UnMASCK / 2019-1333
Conditions: Mood Disorders, Major Depressive Disorder, Bipolar Disorder I, Bipolar Disorder II, Persistent Depressive Disorder (Dysthymia), Cyclothymia
Study type: Observational
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: University of Illinois ChicagoUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 17 Sep 2020 (actual)
Primary completion: 31 Mar 2025 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 24 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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.
Control group	–	–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.

Who may qualify

Ages: 25 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
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.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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
1. 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. 2. 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. 3. 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.
1. 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. 2. 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. 3. 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
1. 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). 2. 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). 3. 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.

Related trials for Mood Disorders

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Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Olusola Ajilore, MD, PhD principal investigator

University of Illinois Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Mood Disorders and Major Depressive Disorder, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuroimaging (time frame: Change from week 2 to week 4.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04358900.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.