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.
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.