• Alexa Mazur, Harrison Costantino, Prentice Tom, Michael P Wilson, and Ronald G Thompson.
• Kintsugi Mindful Wellness, Inc, San Francisco, California.
• Ann Fam Med. 2025 Jan 13.

PurposeMental health screening is recommended by the US Preventive Services Task Force for all patients in areas where treatment options are available. Still, it is estimated that only 4% of primary care patients are screened for depression. The goal of this study was to evaluate the efficacy of machine learning technology (Kintsugi Voice, v1, Kintsugi Mindful Wellness, Inc) to detect and analyze voice biomarkers consistent with moderate to severe depression, potentially allowing for greater compliance with this critical primary care public health need.MethodsWe performed a cross-sectional study from February 1, 2021 to July 31, 2022 to examine ≥25 seconds of free-form speech content from English-speaking samples captured from 14,898 unique adults in the United States and Canada. Participants were recruited via social media, provided informed consent, and their voice biomarker results were compared with a self-reported Patient Health Questionnaire-9 (PHQ-9) at a cut-off score of 10 (moderate to severe depression).ResultsFrom as few as 25 seconds of free-form speech, machine learning technology was able to detect vocal characteristics consistent with an increased PHQ-9 ≥10, with a sensitivity of 71.3 (95% CI, 69.0-73.5) and a specificity of 73.5 (95% CI, 71.5-75.5).ConclusionsMachine learning has potential utility in helping clinicians screen patients for moderate to severe depression. Further research is needed to measure the effectiveness of machine learning vocal detection and analysis technology in clinical deployment.© 2025 Annals of Family Medicine, Inc.

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