Kintsugi Voice Device Study

Status Completed

Clinical Trial Summary

The Kintsugi Voice Device Pilot Study is a two arm pilot diagnostic accuracy study. Eligible enrolled participants will complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) instruments, as well as complete a remote video-recorded Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID) with a trained psychiatrist. This study seeks to evaluate the ability of the Device to aid clinical assessment for depression and anxiety by comparing its output with the established diagnostic standard consisting of a diagnosis made by a specialist clinician based on DSM-5 criteria. The order of the assessments will be randomized. Audio captured during the SCID interview will be inputted into a machine learning model to determine the diagnostic accuracy of the Kintsugi Voice Device.

Clinical Trial Description

This is a prospective study of up to 100 subjects, ages >22 years of age. The study is striving for a 50%/50% split of subjects who have depression and/or anxiety and subjects who do not have depression and/or anxiety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05554042
Study type	Observational
Source	Kintsugi Mindful Wellness, Inc.
Contact
Status	Completed
Phase
Start date	September 23, 2022
Completion date	July 5, 2023

View Details

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