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Sponsor: Kintsugi Mindful Wellness, Inc.
Conditions: Depression, Depression Moderate, Depression Severe, Depression Mild
Interventions: Kintsugi Voice Device
Countries: United States
A prospective, single arm, non-randomized, pilot clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-CT) for up to 500 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks.
Sex: ALL
Age: 22 Years to —
Healthy volunteers: Yes
Study type: OBSERVATIONAL
Inclusion Criteria: * Age \>22 at the time of informed consent * 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 * Fluency in English * Availability for the duration of the study * Resides in the United States at the time of consent and during completion of study * Contributes to the approximately 50/50 depressed/healthy study population distribution Exclusion Criteria: * 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.
- Berkeley, California, United States