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DepressionNCT06374056

Kintsugi Voice Device Pilot Study

An observational study of Depression and Depression Moderate, run by Kintsugi Mindful Wellness, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for
Depression, Depression Moderate, Depression Severe
What is being tested?
Kintsugi Voice Device
Type of treatment
Medical device
How many people
262 participants
Where
1 siteUnited States
Study dates
22 Mar 2024to 28 Feb 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kintsugi Mindful Wellness Inc.

    Berkeley, California, 94707

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Kintsugi Voice Device
Keywords
Depression
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kintsugi Voice DeviceDevice

    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.

Study groups in NCT06374056
Study groupRoleWhat they receive
DepressedAll 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.
Receives: Device: Kintsugi Voice Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Day 1

Secondary outcomes (3)

  1. PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5

    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.

    Measured: Day 1

  2. Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT

    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

    Measured: Day 1

  3. Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9

    Determine the performance of the Device in discriminating the presence of a current significant depressive symptoms compared to the PHQ-9

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start22 Mar 2024
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06374056
Sponsor's protocol ID
0458
Status last verified
Apr 2024
First submitted
9 Apr 2024
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: 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.

Publications

  • Evans-Lacko S, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Benjet C, Bruffaerts R, Chiu WT, Florescu S, de Girolamo G, Gureje O, Haro JM, He Y, Hu C, Karam EG, Kawakami N, Lee S, Lund C, Kovess-Masfety V, Levinson D, Navarro-Mateu F, Pennell BE, Sampson NA, Scott KM, Tachimori H, Ten Have M, Viana MC, Williams DR, Wojtyniak BJ, Zarkov Z, Kessler RC, Chatterji S, Thornicroft G. Socio-economic variations in the mental health treatment gap for people with anxiety, mood, and substance use disorders: results from the WHO World Mental Health (WMH) surveys. Psychol Med. 2018 Jul;48(9):1560-1571. doi: 10.1017/S0033291717003336. Epub 2017 Nov 27.

    PubMed 29173244

  • GBD Results Tool | GHDx. Accessed January 31, 2022. http://ghdx.healthdata.org/gbd-results-tool?params=gbd-api-2019-permalink/d780dffbe8a381b25e1416884959e88b

  • Major Depression. National Institute of Mental Health. Published January 2022. Accessed January 31, 2022. https://www.nimh.nih.gov/health/statistics/major-depression

  • Facts & Statistics | Anxiety and Depression Association of America, ADAA. Accessed January 31, 2022. https://adaa.org/understanding-anxiety/facts-statistics

  • Domogauer JD, Colangelo N, Aggarwal R. Study of Total and Undiagnosed Depression in a Cancer Patient Population at an Urban Cancer Center. International Journal of Radiation Oncology*Biology*Physics. 2017;99(2):S10. doi:10.1016/J.IJROBP.2017.06.040

  • Lewis K, Marrie RA, Bernstein CN, Graff LA, Patten SB, Sareen J, Fisk JD, Bolton JM; CIHR Team in Defining the Burden and Managing the Effects of Immune-Mediated Inflammatory Disease. The Prevalence and Risk Factors of Undiagnosed Depression and Anxiety Disorders Among Patients With Inflammatory Bowel Disease. Inflamm Bowel Dis. 2019 Sep 18;25(10):1674-1680. doi: 10.1093/ibd/izz045.

    PubMed 30888037

  • Sorkin DH, Ngo-Metzger Q, Billimek J, August KJ, Greenfield S, Kaplan SH. Underdiagnosed and undertreated depression among racially/ethnically diverse patients with type 2 diabetes. Diabetes Care. 2011 Mar;34(3):598-600. doi: 10.2337/dc10-1825. Epub 2011 Jan 27.

    PubMed 21273497

  • McDaid D, Park A la. Counting All the Costs: The Economic Impact of Comorbidity. Key Issues in Mental Health. 2015;179:23-32. doi:10.1159/000365941

  • Depression - Clinical Preventive Service Recommendation. American Academy of Family Physicians. Accessed February 1, 2022. https://www.aafp.org/family-physician/patient-care/clinical-recommendations/all-clinical-recommendations/depression.html

  • Siu AL; US Preventive Services Task Force (USPSTF); Bibbins-Domingo K, Grossman DC, Baumann LC, Davidson KW, Ebell M, Garcia FA, Gillman M, Herzstein J, Kemper AR, Krist AH, Kurth AE, Owens DK, Phillips WR, Phipps MG, Pignone MP. Screening for Depression in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jan 26;315(4):380-7. doi: 10.1001/jama.2015.18392.

    PubMed 26813211

  • Olfson M, Kroenke K, Wang S, Blanco C. Trends in office-based mental health care provided by psychiatrists and primary care physicians. J Clin Psychiatry. 2014 Mar;75(3):247-53. doi: 10.4088/JCP.13m08834.

    PubMed 24717378

  • Aboraya A. The Reliability of Psychiatric Diagnoses: Point-Our psychiatric Diagnoses are Still Unreliable. Psychiatry (Edgmont). 2007 Jan;4(1):22-5. No abstract available.

    PubMed 20805925

  • Kraemer HC, Kupfer DJ, Clarke DE, Narrow WE, Regier DA. DSM-5: how reliable is reliable enough? Am J Psychiatry. 2012 Jan;169(1):13-5. doi: 10.1176/appi.ajp.2011.11010050. No abstract available.

    PubMed 22223009

  • Mitchell AJ, Vaze A, Rao S. Clinical diagnosis of depression in primary care: a meta-analysis. Lancet. 2009 Aug 22;374(9690):609-19. doi: 10.1016/S0140-6736(09)60879-5. Epub 2009 Jul 27.

    PubMed 19640579

  • Williams SZ, Chung GS, Muennig PA. Undiagnosed depression: A community diagnosis. SSM Popul Health. 2017 Jul 28;3:633-638. doi: 10.1016/j.ssmph.2017.07.012. eCollection 2017 Dec.

    PubMed 29349251

Questions about this trial

What is this clinical trial studying?

An observational study of Depression and Depression Moderate, run by Kintsugi Mindful Wellness, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5 (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06374056, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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