Aiberry AI Mental Health Screening Platform

Terminated

• Conditions: Depression; Anxiety; Healthy

• Registration Number: NCT04994899
• Lead Sponsor: Aiberry, Inc

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.

Study Timeline

• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-06
• Study Start: 2022-09-22
• Status Verified: 2023-02
• Primary Completion: 2023-04-06
• Study Completion: 2023-04-06
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Classification of moderate-severe depression	Single assessment	Accuracy, sensitivity, specificity, and positive and negative predictive value when classifying whether participants meet established cut-off criterion for suspected MDD (QIDS \> 10)
Classification of moderate-severe anxiety	Single assessment	Accuracy, sensitivity, specificity, and positive and negative predictive value when classifying whether participants meet established cut-off criterion for suspected GAD (GAD-7 \> 9)
Prediction of anxiety score from a self-report instrument	Single assessment	Error when predicting anxiety severity (none, mild, moderate, severe) based on GAD-7.

Trial Locations

Locations (3)

Hapworth Research Inc.; 🇺🇸 New York, New York, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States