Aiberry AI Mental Health Screening Platform | NCT04994899

Studies
Aiberry AI Mental Health Screening Platform

NCT04994899

Sponsor

Aiberry, Inc

Status

Terminated

Last Update Posted

Jun 9, 2023Actual

Enrollment

800Actual

Phase

Not provided

Conditions

Depression
Anxiety
Healthy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Data collection is no longer necessary

Expanded Access Info

Start Date

Sep 22, 2022Actual

Primary Completion Date

Apr 6, 2023Actual

Completion Date

Apr 6, 2023Actual

First Submitted Date

Jul 30, 2021

First Submission Date that Met QC Criteria

Jul 30, 2021

First Posted Date

Aug 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2023

Last Update Posted Date

Jun 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prediction of depression score from a self-report instrument	Error when predicting depression severity (none, mild, moderate, severe) based on QIDS-SR-16.	Single assessment

Secondary Outcomes

Measure	Description	Time Frame
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)	Single assessment
Classification of moderate-severe anxiety

Other Outcomes

Measure	Description	Time Frame
Prediction of specific anxiety and depression symptoms	Error when predicting responses to individual items on the QIDS-SR or GAD-7.	Single assessment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 13 to 79 years old
English-speaking

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

79 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Individuals with or without prior mental health diagnosis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona		Tucson	Arizona	85719	United States
Georgetown University

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided