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| Name | Class |
|---|---|
| Vituity | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Instruments Followed By SCID | 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. |
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| SCID Followed By Instruments | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kintsugi Voice Device | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged 22 years of age and older at the time of consent who meet all study inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Grace Chang, MBA | Kintsugi Mindful Wellness, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kintsugi Mindful Wellness, Inc. | Berkeley | California | 94705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29349251 | Background | Williams SZ, Chung GS, Muennig PA. Undiagnosed depression: A community diagnosis. SSM Popul Health. 2017 Jul 28;3:633-638. doi: 10.1016/j.ssmph.2017.07.012. eCollection 2017 Dec. | |
| 32568190 | Background | Thomas JA, Burkhardt HA, Chaudhry S, Ngo AD, Sharma S, Zhang L, Au R, Hosseini Ghomi R. Assessing the Utility of Language and Voice Biomarkers to Predict Cognitive Impairment in the Framingham Heart Study Cognitive Aging Cohort Data. J Alzheimers Dis. 2020;76(3):905-922. doi: 10.3233/JAD-190783. |
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IPD will not be shared with other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 7, 2022 | Sep 27, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 22, 2022 | Sep 27, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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|
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 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |