DepressionNCT04994899
Aiberry AI Mental Health Screening Platform
An observational study of Depression and Anxiety, run by Aiberry, Inc at 3 sites in United States.
Trial summary
Aiberry is creating a multi-modal artificial intelligence (AI) platform that analyzes facial, audio and text features to screen for mental illness. This multicenter study will be used to collect data to validate the platform's ability to detect depression and anxiety in a diverse patient population. Read more about this study
- Who is it for?
- Ages 13 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Healthy
- How many people
- 800 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Sep 2022to 6 Apr 2023
- 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 13 to 79 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals with or without prior mental health diagnosis.
Who may be able to join
- Age 13 to 79 years old
- English-speaking
Who cannot join
- Previous participant in the study, within the last three months
- Individuals unable to verbally respond to standardized questions
- Individuals unable to participate in a virtual visit as they do not have the right hardware (phone/laptop) or no internet connectivity
- Individuals unable to provide consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hapworth Research Inc.
New York, New York, 10022
University of Arizona
Tucson, Arizona, 85719
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: Development of the Aiberry AI Mental Health Screening Platform in a Diverse Population
Aiberry is creating a multi-modal artificial intelligence (AI) platform that analyzes facial, audio and text features to screen for mental illness. This multicenter study will be used to collect data to validate the platform's ability to detect depression and anxiety in a diverse patient population.
Read the detailed description
Aiberry is developing a proprietary AI platform that leverages machine learning to screen for mental illness using a multi-modal approach that fuses rich visual, audio, text, gestures, and eye gaze information. Our objective in this study is to validate algorithms that predict how individuals will respond to self-report questionnaires used to screen for major depressive disorder (MDD) and general anxiety disorder (GAD). Prior to enrollment, participants will participate in a baseline screening questionnaire to collect demographic information, health history, and current depression severity. If participants meet eligibility requirements and demographic recruitment targets, they will be invited to a single virtual study visit in which they will complete a 10-15 minute recorded interview with a study staff member along with three brief self-report questionnaires: 1) the Quick Inventory of Depression Symptoms Self Report (QIDS-SR-16), 2) the General Anxiety Disorder (GAD-7), and 3) the mini-version of the Mood and Anxiety Questionnaire (mini-MASQ), which will be used as a validity check that participant responses are consistent between this and the previous two questionnaires. We will evaluate how well the AI technology is able to predict self-reported symptoms of depression and anxiety by analyzing facial, audio, and text features from interview videos.
- Conditions
- Depression, Anxiety, Healthy
- Medical subject headings
- Depression, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of depression score from a self-report instrument
Error when predicting depression severity (none, mild, moderate, severe) based on QIDS-SR-16.
Measured: Single assessment
Secondary outcomes (3)
Classification of moderate-severe depression
Accuracy, sensitivity, specificity, and positive and negative predictive value when classifying whether participants meet established cut-off criterion for suspected MDD (QIDS > 10)
Measured: Single assessment
Classification of moderate-severe anxiety
Accuracy, sensitivity, specificity, and positive and negative predictive value when classifying whether participants meet established cut-off criterion for suspected GAD (GAD-7 > 9)
Measured: Single assessment
Prediction of anxiety score from a self-report instrument
Error when predicting anxiety severity (none, mild, moderate, severe) based on GAD-7.
Measured: Single assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start22 Sep 2022
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Why it stopped: Data collection is no longer necessary
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aiberry, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994899
- Sponsor's protocol ID
- Aiberry
- Status last verified
- Feb 2023
- First submitted
- 30 Jul 2021
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Aiberry AI Mental Health Screening Platform in a Diverse Population
- ClinicalTrials.gov ID
- NCT04994899
- Acronym / sponsor ID
- Aiberry
- Conditions
- Depression, Anxiety, Healthy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Data collection is no longer necessary
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Aiberry, IncIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 6 Aug 2021 (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.
Aiberry is creating a multi-modal artificial intelligence (AI) platform that analyzes facial, audio and text features to screen for mental illness. This multicenter study will be used to collect data to validate the platform's ability to detect depression and anxiety in a diverse patient population.
Detailed description
Aiberry is developing a proprietary AI platform that leverages machine learning to screen for mental illness using a multi-modal approach that fuses rich visual, audio, text, gestures, and eye gaze information. Our objective in this study is to validate algorithms that predict how individuals will respond to self-report questionnaires used to screen for major depressive disorder (MDD) and general anxiety disorder (GAD). Prior to enrollment, participants will participate in a baseline screening questionnaire to collect demographic information, health history, and current depression severity. If participants meet eligibility requirements and demographic recruitment targets, they will be invited to a single virtual study visit in which they will complete a 10-15 minute recorded interview with a study staff member along with three brief self-report questionnaires: 1) the Quick Inventory of Depression Symptoms Self Report (QIDS-SR-16), 2) the General Anxiety Disorder (GAD-7), and 3) the mini-version of the Mood and Anxiety Questionnaire (mini-MASQ), which will be used as a validity check that participant responses are consistent between this and the previous two questionnaires. We will evaluate how well the AI technology is able to predict self-reported symptoms of depression and anxiety by analyzing facial, audio, and text features from interview videos.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with or without prior mental health diagnosis.
Key inclusion criteria (2 listed)
- Age 13 to 79 years old
- English-speaking
Key exclusion criteria (4 listed)
- Previous participant in the study, within the last three months
- Individuals unable to verbally respond to standardized questions
- Individuals unable to participate in a virtual visit as they do not have the right hardware (phone/laptop) or no internet connectivity
- Individuals unable to provide consent
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
Prediction of depression score from a self-report instrument
Time frame: Single assessment
Error when predicting depression severity (none, mild, moderate, severe) based on QIDS-SR-16.
3 secondary outcomes
Classification of moderate-severe depression
Time frame: Single assessment
Classification of moderate-severe anxiety
Time frame: Single assessment
Prediction of anxiety score from a self-report instrument
Time frame: Single assessment
Results and safety
The study was stopped early (reason given: Data collection is no longer necessary). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Aiberry, Inc at 3 sites 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Data collection is no longer necessary). Results are not available in the source record.
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?
Prediction of depression score from a self-report instrument (time frame: Single assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2023.