Evaluating the Kintsugi Voice Device for assessing depression
Kintsugi Voice Device SCID-5 Pivotal Study
This study is testing a new device that listens to your voice to see if it can help identify depression in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Kintsugi Mindful Wellness, Inc. Industry-sponsored |
| Locations | 1 site (Berkeley, California) |
| Trial ID | NCT06809907 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the Kintsugi Voice Device as a tool for assessing depression in adults. It will compare the device's output with clinician diagnoses using the Structured Clinical Interview for DSM-5. The study will involve up to 1000 English-speaking adults aged 22 and older living in the United States, with recruitment lasting one year and participation for up to two weeks. Participants will need access to a device with a microphone and internet to engage in the study.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 22 and older who experience disruptions in daily activities due to depression.
Not a fit: Patients with impairments affecting their ability to speak or use a computer for online surveys may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, innovative method for assessing depression that enhances clinical evaluations.
How similar studies have performed: While the use of voice analysis in mental health assessment is emerging, this specific approach with the Kintsugi Voice Device is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age \>22 at the time of informed consent Self-reported disruption to activities of daily living (e.g. missed scheduled healthcare appointments, unable to concentrate on tasks like reading, working, or completing daily activities, or difficult completing activities such as exercise, diet, or recreation) Access to a laptop, smartphone, tablet, or other device with a functioning microphone and access to the Internet Stated willingness to be video and audio recorded as part of the study Stated willingness to comply with all study procedures and availability for the duration of the study Functional English capacity in the home environment Availability for the duration of the study Resides in the United States at the time of consent and during completion of study \- Exclusion Criteria: * Participants with at least one of the following conditions will be excluded: Any impairment that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., visual impairment, motor impairment, and/or hearing impairment) Any lifetime history of neurological disease that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., Central Nervous System disorders, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and/or Parkinson's Disease) Any lifetime history of Stroke, cognitive defect (E.g., dementia or Alzheimer's disease), and/or Traumatic Brain Injury Presence of voice disorders that impacts their ability to speak (E.g., acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia) Past or active heavy smokers (an average of \>20 cigarettes per day) Subjects who have previously participated in any Kintsugi-sponsored study
Where this trial is running
Berkeley, California
- Kintsugi (Decentralized, Virtual Study) — Berkeley, California, United States (Recruiting)
Study contacts
- Study coordinator: Dr. Kolby Walker D.O.
- Email: Kolby.Walker@vituity.com
- Phone: (209) 662-5369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.