Voice Biomarkers Predictive of Depression and Anxiety

Study Overview
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Brief Summary
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The objective of this study is to collect data to improve the sensitivity and specificity of Kintsugi Voice's (formerly KiVATM) predictions on audio files. A web-based audio recording tool will be used to record voice sample and ask participants the PHQ-9 and GAD-7 questions. A voluntary subset of participants will then be assessed by mental health professionals with the Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) scores.

Detailed Description
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Participants will be recruited via various online mediums to participate in a voluntary observational study. Completing the consent and survey on their smart-phone, tablet, or computer, the participant will be asked to provide a 1-minute response to an audio prompt How was your day? After recording their response, the participant will be asked to complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 measures independently. In a second voluntary phase of the study, participants who indicated a score higher than 20, will be contacted by the research team via email to determine if they are interested in a voluntary follow-up to their initial study participation. Participants who would like to take part in the additional survey will complete additional voice recording responses to prompts and complete the Patient History Questionnaire and Generalized Anxiety Disorder-7. These participants will be contacted by a Mental Health Professional to discuss seeking mental health resources and clinicians, as well as, complete the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale via the telephone.

Official Title
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Voice Biomarkers Predictive of Depression and Anxiety: An Observational Study

Conditions
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Depression, Anxiety, Healthy, Mental Health Wellness 1

Intervention / Treatment
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* Diagnostic Test: Patient Health Questionnaire-9
* Diagnostic Test: Generalized Anxiety Disorder-7
* Diagnostic Test: Hamilton Depression Rating Scale
* Diagnostic Test: Hamilton Anxiety Rating Scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males and or females over the age of 18 at the time of informed consent. Adults with a known history of depression and/or anxiety and adults without a known history of depression and/or anxiety will be included in this study. Access to a laptop, smart-phone or tablet with a functioning microphone Stated willingness to comply with all study procedures and availability for the duration of the study Fluency in English Exclusion Criteria: Visual impairment that would make it difficult for the participant to see the web-based survey Motor impairment that would make it difficult for the participant to use the web-based survey

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main Study Cohort<br>A web-based audio recording tool will be used to record voice sample answering the prompt, How are you feeling today? Participants are asked to speak for 1-minute. Following the recording, participants are asked to complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 questions. | Diagnostic Test: Patient Health Questionnaire-9<br>* The Patient Health Questionnaire-9 is a nine question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Patient Health Questionnaire-9 is scored from 0 to 27 where higher scores are associated with more severe depression.<br>* Other names: PHQ-9;Diagnostic Test: Generalized Anxiety Disorder-7<br>* The Generalized Anxiety Disorder-7 is a seven question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Generalized Anxiety Disorder-7 is scored from 0 to 21 where higher scores are associated with more severe anxiety.<br>* Other names: GAD-7;|
| Selected Self-Reported Depression Cohort<br>The Researcher will review Patient Health Questionnaire-9 scores of all the participants and select the subset that self-reported a scored greater than 20, on a scale from 0 to 27. Participants will be approached via email to complete an additional administration of the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 questionnaires and be offered resources for depression and anxiety and how to set up an appointment with a mental health professional. | Diagnostic Test: Patient Health Questionnaire-9<br>* The Patient Health Questionnaire-9 is a nine question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Patient Health Questionnaire-9 is scored from 0 to 27 where higher scores are associated with more severe depression.<br>* Other names: PHQ-9;Diagnostic Test: Generalized Anxiety Disorder-7<br>* The Generalized Anxiety Disorder-7 is a seven question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Generalized Anxiety Disorder-7 is scored from 0 to 21 where higher scores are associated with more severe anxiety.<br>* Other names: GAD-7;Diagnostic Test: Hamilton Depression Rating Scale<br>* The Hamilton Depression Rating Scale is administered by a mental health profession and includes twenty-one questions asking about how the participant has been feeling in the past week. The Hamilton Depression Rating Scale is scored from 0 to 45 where higher scores are associated with more severe depression.<br>* Other names: HAM-D;Diagnostic Test: Hamilton Anxiety Rating Scale<br>* The Hamilton Anxiety Rating Scale is administered by a mental health profession and includes fourteen questions asking about how the participant has been feeling in the past week. The Hamilton Anxiety Rating Scale is scored from 0 to 56 where higher scores are associated with more severe anxiety.<br>* Other names: HAM-A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale | Participants will be interviewed by mental health professionals using the clinically validated Hamilton Depression Rating Scale, which has a score range of 0 to 54, where higher scores are associated with higher severity of depression. | Through study completion, on average 12months | 
| Hamilton Anxiety Rating Scale | Participants will be interviewed by mental health professionals using the clinically validated Hamilton Anxiety Rating Scale, which has a score range of 0 to 56, where higher scores are associated with higher severity anxiety. | Through study completion, on average 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health, depression, anxiety, Artificial Intelligence