Kintsugi Voice Device Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Kintsugi Voice Device Study

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Diagnostic Test: Kintsugi Voice Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects greater than or equal to 22 years of age at the time of informed consent Participants must be able to read, understand, and sign the Informed Consent Form Access to a laptop, smartphone, tablet, or other Device with a functioning microphone Participants must be willing to be videotaped as part of the study Stated willingness to comply with all study procedures and availability for the duration of the study Fluency in English Availability for the duration of the study The participant must reside within the state of California Exclusion Criteria: Any impairment that would prevent participants from completing an online survey and/or engage in clinician assessment interviews (e.g., visual impairment, motor impairment, hearing impairment, acute intoxication) Any known history of neurodegenerative or Central Nervous System disorders Any known history of schizophrenia, psychosis, or severe cognitive deficits Any known presence of disorders that may lead to false signal of depression or anxiety including Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Parkinson's Disease, Stroke, Traumatic Brain Injury Presence of voice disorders that may impact vocal cords such as acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia Any known history of vocal cord injury or cerebrovascular accident or head trauma with residual dysarthria in the past year Past or active heavy smokers if there is impact on the vocal cords Any known history of congenital deafness Subjects who do not speak English Subjects who do not live in the United States Subjects who have previously participated in any Kintsugi-sponsored study

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Instruments Followed By SCID<br>Participants will complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 instruments virtually. Participants will then complete a video recorded virtual Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-5. | Diagnostic Test: Kintsugi Voice Device<br>* The Kintsugi Voice Device is an API with an underlying machine learning algorithm that drives the Device outputs. Depression and Anxiety are separate algorithms. The Device is designed to be adjunct to clinical assessment and estimate the presence of vocal characteristics consistent with a significant depressive episode and/or a clinically significant anxiety state, which are a necessary condition for the diagnosis of lifetime mood disorders, such as major depressive disorder and/or generalized anxiety disorder. Kintsugi Voice Device is not to be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.<br>|
| SCID Followed By Instruments<br>Participants will complete a video recorded virtual Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-5. Participants will then complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 instruments virtually. | Diagnostic Test: Kintsugi Voice Device<br>* The Kintsugi Voice Device is an API with an underlying machine learning algorithm that drives the Device outputs. Depression and Anxiety are separate algorithms. The Device is designed to be adjunct to clinical assessment and estimate the presence of vocal characteristics consistent with a significant depressive episode and/or a clinically significant anxiety state, which are a necessary condition for the diagnosis of lifetime mood disorders, such as major depressive disorder and/or generalized anxiety disorder. Kintsugi Voice Device is not to be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of the Kintsugi Voice Device for a Significant Depressive Episode | Discriminates the presence of a significant depressive episode using the Structure Clinical Interview for the Diagnostic Statistical Manual for Mental Disorders-5 as the ground truth, diagnostic standard | Through study completion, on average 2 weeks | 
| Sensitivity and Specificity of the Kintsugi Voice Device for a Significant Anxiety State | Discriminates the presence of a significant anxiety state using the Structure Clinical Interview for the Diagnostic Statistical Manual for Mental Disorders-5 as the ground truth, diagnostic standard | Through study completion, on average 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Indeterminate Outputs | Measure the proportion of participants who complete the study and the device output is Indeterminate. | Through study completion, on average 2 weeks. | 
| Sensitivity and Specificity of the Kintsugi Voice Device with Patient Health Questionnaire-9 Ground Truth | Discriminating the presence of a significant depressive episode against the Patient Health Questionnaire-9 as the ground truth. | Through study completion, on average 2 weeks | 
| Sensitivity and Specificity of the Kintsugi Voice Device with Generalized Anxiety Disorder-7 Ground Truth | Discriminating the presence of a significant anxiety state against the Generalized Anxiety Disorder-7 as the ground truth. | Through study completion, on average 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health, depression, anxiety, remote research, artificial intelligence, diagnostic