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Kintsugi Voice Device Study for Depression

This study is looking at how well the Kintsugi Voice Device can help doctors screen for moderate to severe depression in adults aged 22 and older. The device uses your voice to look for signals that might suggest depression. Researchers will compare the device's results to a diagnosis made by a doctor using a standard interview (SCID-5-RV). You might be able to join if you are 22 or older, live in the United States, speak English, and have daily activities disrupted by your symptoms. The study aims to enroll up to 1000 people, but its current recruitment status is unclear.

Study design
This is an observational study that will enroll up to 1000 participants. It is a single-arm study, meaning everyone receives the same intervention.
What's involved
Your participation in this study would last for up to 2 weeks. You would need access to a laptop, smartphone, tablet, or other device with a functioning microphone.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Day 1, suggesting a short follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06809907

Kintsugi Voice Device Pivotal Study

Completed
Not specifiedAges 22+Observational
Kintsugi Mindful Wellness, Inc.
~1,600 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Kintsugi Voice Device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1. Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5
Measured over Day 1

Conditions

Depression
Depression Moderate
Depression Severe
Depression Mild

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Depression

NCT06809907

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Kintsugi (Decentralized, Virtual Study)

    Berkeley, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Exclusion

Participants with at least one of the following conditions will be excluded:

What this trial measures

  • 1. Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5Day 1

    Achieve a composite lower bound of sensitivity greater than or equal to 70% and specificity greater than or equal to 70% for the KV Device relative to the high diagnostic confidence clinical reference standard as defined in Section 7.4.1 for which the device provides a result