Kintsugi Voice Device Pilot Study

October 7, 2024 updated by: Kintsugi Mindful Wellness, Inc.

Kintsugi Voice Device SCID-5-CT Pilot Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Depression affects approximately 30% of people every year in the United States. Detecting mental health conditions early can help patients get the help they need sooner. Machine Learning Devices may be one way to help clinicians identify patients with mental health conditions. Clinicians may then be able to help patients receive the right level of care earlier. Many researchers are working to increase mental health screening. Machine Learning can detect subtle patterns like changes in the voice when someone is experiencing mental health conditions. Changes in the voice associated with a mental health condition are voice biomarkers.

The purpose of this study is to find correlations between voice and how people sound with clinical diagnoses. Kintsugi Mindful Wellness, Inc. has developed a tool, the Kintsugi Voice Device, that assesses mental health and conditions like depression by studying the voice. The study's goal is to test the ability of the Device to identify depressive symptoms.

Up to 500 people will take part in this research. Subject recruitment is expected to take up to 1 year. Completion of the study activities may take about 2 hours but subjects may stay enrolled for up to 2 weeks based on clinician availability for scheduling the Structured Clinical Interview for DSM-5 (SCID) interview.

Study participants will:

  • Answer brief self-reported eligibility confirmation questionnaires. These answers help the researchers understand participant health history.
  • Schedule a teleconference with a licensed Clinical Psychologist to evaluate their mental health over Zoom. The Clinical Psychologist will guide participants through the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT). The Clinical Psychologist will be licensed in the participant's state of residence. This assessment will be video and audio recorded for quality assurance purposes. If participants do not agree to being videotaped and/or audio recorded, they will be unable to join the study. The SCID-5-CT assessment is for research purposes only and is not intended for treatment purposes. The results of the SCID will not be shared with participants.

On the day of the teleconference with a licensed Clinical Psychologist participants will:

  • Complete three brief self-assessment surveys asking about their electronic device, mental health and quality of life: the Patient Health Questionnaire-9 (PHQ-), Generalized Anxiety Disorder-7 (GAD-7), and the World Health Organization Quality of Life (WHOQOL). These assessments will take approximately 15 minutes in total.
  • Participants will provide an audio recording in response to 3 prompts of their choosing. The audio recording will be inputted to the Kintsugi Voice Device to receive a prediction of current signs of depression. The Kintsugi Voice Device Prediction is for research purposes only and will not be shared with participants.
  • Complete the SCID-5-CT while being videotaped and audio recorded with a licensed psychologist or psychiatrist and participant responses will be recorded. The SCID will allow the clinician to assess participants' current mental status.

This study is intended for research purposes and is not intended for treatment and/or diagnostic purposes. The risks to this study are minimal and/or temporary and short lived. The study team has implemented procedures to minimize them wherever possible. There is always the potential for breach of confidentiality. To minimize this risk, all entries are encrypted. Researchers de-identify personal information using IDs. Researchers will store all data in a secure, password protected database and Google Cloud Platform bucket. Participation may bring up emotional content which could temporarily impact mood. To minimize this risk, everyone will be emailed a list of mental health resources.

There is no cost to subjects for participation. There may be no direct benefit from participation. Indirect benefits may include reduction in stress, learning more about mental health. Knowledge gained from the study could potentially benefit patients in the future.

Only personal and health information directly related to the research is collected, for safety purposes, or as required to provide participants with payment, including:

  • Name
  • Age
  • Address
  • Phone Number
  • Email Address
  • Demographic information (e.g. race, gender, and ethnicity)
  • English Proficiency
  • Emergency Contact Information
  • Audio recording of the SCID-5-CT
  • Video recording of the SCID-5CT
  • Audio recordings in response to prompts
  • Brief Medical History and Medications
  • Results of the SCID-5-CT
  • Device Information
  • PHQ-9 Responses
  • GAD-7 Responses
  • Behavioral and Quality of Life Survey Responses

Identifiable data will be kept for 7 years. De-identified data will be kept indefinitely.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94707
        • Kintsugi Mindful Wellness Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study will enroll up to 500 English speaking subjects >22 years old. Only subjects who meet all eligibility criteria and sign the informed consent will be enrolled. Participants who do not meet the criteria required for participation will not be presented with the opportunity to participate. Screen failures will not be considered a part of this research study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Depressed
All study participants will undergo the same study procedures. All individuals will complete brief online assessments about their emotional and physical wellbeing, provide audio recorded voice responses to prompts, and complete the SCID-5-CT with a clinician licensed in their state of residence while being audio and video recorded for quality assurance purposes.
Device: Kintsugi Voice Device

The Kintsugi Voice Device is intended to be used to screen for the presence of voice signals consistent with a current moderate to severe depressive episode in patients aged 22 and older. The device is intended to be used by care providers licensed to screen for depression and in settings where the screening for depression occurs. The device is neither to be used in lieu of a complete patient evaluation nor to supplant any of the clinician's standard assessments for the screening or diagnosis of depression.

The Kintsugi Voice Device is comprised of a software API and machine learning model that utilizes recorded voice samples as inputs and outputs the detection of signals consistent with current moderate to severe depressive episode as outputs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5
Time Frame: Day 1
Determine the performance of the KV Device in discriminating the presence of a current significant depressive episode using the SCID-5-CT diagnosis of current MDD and/or MDE using sensitivity and specificity.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5
Time Frame: Day 1
Determine the performance of the KV Device in discriminating the presence of a current significant depressive episode using the SCID-5-CT diagnosis of current MDD and/or MDE using positive predictive value, negative predictive value, area under the curve, and F-score.
Day 1
Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT
Time Frame: Day 1
Determine the performance of the KV Device in discriminating the severity of a current significant depressive episode using the SCID-5-CT severity assessment for those with a diagnosis of current MDD and/or MDE
Day 1
Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9
Time Frame: Day 1
Determine the performance of the Device in discriminating the presence of a current significant depressive symptoms compared to the PHQ-9
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kintsugi Mindful Wellness, Inc.

Collaborators

Sonar Strategies
Vituity Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2024

Primary Completion (Estimated)

March 22, 2025

Study Completion (Estimated)

July 22, 2025

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0458

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study team does not current intend to publish the data associated with the study. Should the study team publish study data, the study data may be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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