NCT05455905

Voice Biomarkers Predictive of Depression and Anxiety

Voice Biomarkers Predictive of Depression and Anxiety: An Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19,533 (actual)
• Sponsor: Kintsugi Mindful Wellness, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Depression, Anxiety
• Healthy
• Mental Health Wellness 1

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Patient Health Questionnaire-9	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.
DIAGNOSTIC_TEST	Generalized Anxiety Disorder-7	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.
DIAGNOSTIC_TEST	Hamilton Depression Rating Scale	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.
DIAGNOSTIC_TEST	Hamilton Anxiety Rating Scale	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.

Timeline

• Start date: 2021-09-14
• Primary completion: 2022-09-11
• Completion: 2022-09-11
• First posted: 2022-07-13
• Last updated: 2022-09-15

Locations

1 site across 1 country: United States