Voice Biomarkers Predictive of Depression and Anxiety

Completed

• Conditions: Depression, Anxiety; Healthy; Mental Health Wellness 1
• Interventions: Diagnostic Test: Patient Health Questionnaire-9; Diagnostic Test: Generalized Anxiety Disorder-7; Diagnostic Test: Hamilton Depression Rating Scale; Diagnostic Test: Hamilton Anxiety Rating Scale

• Registration Number: NCT05455905
• Lead Sponsor: Kintsugi Mindful Wellness, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-09-14
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-13
• Status Verified: 2022-09
• Primary Completion: 2022-09-11
• Study Completion: 2022-09-11
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19533

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Selected Self-Reported Depression Cohort	Generalized Anxiety Disorder-7	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.
Selected Self-Reported Depression Cohort	Hamilton Anxiety Rating Scale	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.
Main Study Cohort	Generalized Anxiety Disorder-7	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.
Selected Self-Reported Depression Cohort	Hamilton Depression Rating Scale	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.
Main Study Cohort	Patient Health Questionnaire-9	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.
Selected Self-Reported Depression Cohort	Patient Health Questionnaire-9	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.

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	Through study completion, on average 12months	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.
Hamilton Anxiety Rating Scale	Through study completion, on average 12 months	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.

Trial Locations

Locations (1)

Kintsugi Mindful Wellness, Inc.; 🇺🇸 Berkeley, California, United States