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Depression, AnxietyNCT05554042

Kintsugi Voice Device Study

An observational study of Depression, Anxiety, 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

The Kintsugi Voice Device Pilot Study is a two arm pilot diagnostic accuracy study. Eligible enrolled participants will complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) instruments, as well as complete a remote video-recorded Structured Clinical Interview for the… Read more about this study

Who is it for?
Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for
Depression, Anxiety
What is being tested?
Kintsugi Voice Device
How many people
132 participants
Where
1 siteUnited States
Study dates
23 Sep 2022to 5 Jul 2023
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: Adults aged 22 years of age and older at the time of consent who meet all study inclusion and exclusion criteria.

Who may be able to join

  • Subjects greater than or equal to 22 years of age at the time of informed consent
  • Participants must be able to read, understand, and sign the Informed Consent Form
  • Access to a laptop, smartphone, tablet, or other Device with a functioning microphone
  • Participants must be willing to be videotaped 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
  • The participant must reside within the state of California

Who cannot join

  • Any impairment that would prevent participants from completing an online survey and/or engage in clinician assessment interviews (e.g., visual impairment, motor impairment, hearing impairment, acute intoxication)
  • Any known history of neurodegenerative or Central Nervous System disorders
  • Any known history of schizophrenia, psychosis, or severe cognitive deficits
  • Any known presence of disorders that may lead to false signal of depression or anxiety including Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Parkinson's Disease, Stroke, Traumatic Brain Injury
  • Presence of voice disorders that may impact vocal cords such as acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia
  • Any known history of vocal cord injury or cerebrovascular accident or head trauma with residual dysarthria in the past year
Show all 11Show fewer
  • Past or active heavy smokers if there is impact on the vocal cords
  • Any known history of congenital deafness
  • Subjects who do not speak English
  • Subjects who do not live in the United States
  • 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, 94705

Other trials in United States

About this study

The Kintsugi Voice Device Pilot Study is a two arm pilot diagnostic accuracy study. Eligible enrolled participants will complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) instruments, as well as complete a remote video-recorded Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID) with a trained psychiatrist.

This study seeks to evaluate the ability of the Device to aid clinical assessment for depression and anxiety by comparing its output with the established diagnostic standard consisting of a diagnosis made by a specialist clinician based on DSM-5 criteria.

The order of the assessments will be randomized. Audio captured during the SCID interview will be inputted into a machine learning model to determine the diagnostic accuracy of the Kintsugi Voice Device.

Read the detailed description

This is a prospective study of up to 100 subjects, ages >22 years of age.

The study is striving for a 50%/50% split of subjects who have depression and/or anxiety and subjects who do not have depression and/or anxiety.

Being tested
Kintsugi Voice Device
Keywords
mental health, depression, anxiety, remote research, artificial intelligence, diagnostic
Medical subject headings
Depression, Anxiety Disorders, Psychological Well-Being, Disease

What participants receive

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

  • Kintsugi Voice DeviceDiagnostic test

    The Kintsugi Voice Device is an API with an underlying machine learning algorithm that drives the Device outputs. Depression and Anxiety are separate algorithms. The Device is designed to be adjunct to clinical assessment and estimate the presence of vocal characteristics consistent with a significant depressive episode and/or a clinically significant anxiety state, which are a necessary condition for the diagnosis of lifetime mood disorders, such as major depressive disorder and/or generalized anxiety disorder. Kintsugi Voice Device is not to be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.

Study groups in NCT05554042
Study groupRoleWhat they receive
Instruments Followed By SCIDParticipants will complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 instruments virtually. Participants will then complete a video recorded virtual Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-5.
Receives: Diagnostic Test: Kintsugi Voice Device
SCID Followed By InstrumentsParticipants will complete a video recorded virtual Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-5. Participants will then complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 instruments virtually.
Receives: Diagnostic Test: 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 the Kintsugi Voice Device for a Significant Depressive Episode

    Discriminates the presence of a significant depressive episode using the Structure Clinical Interview for the Diagnostic Statistical Manual for Mental Disorders-5 as the ground truth, diagnostic standard

    Measured: Through study completion, on average 2 weeks

  2. Sensitivity and Specificity of the Kintsugi Voice Device for a Significant Anxiety State

    Discriminates the presence of a significant anxiety state using the Structure Clinical Interview for the Diagnostic Statistical Manual for Mental Disorders-5 as the ground truth, diagnostic standard

    Measured: Through study completion, on average 2 weeks

Secondary outcomes (3)

  1. Proportion of Indeterminate Outputs

    Measure the proportion of participants who complete the study and the device output is Indeterminate.

    Measured: Through study completion, on average 2 weeks.

  2. Sensitivity and Specificity of the Kintsugi Voice Device with Patient Health Questionnaire-9 Ground Truth

    Discriminating the presence of a significant depressive episode against the Patient Health Questionnaire-9 as the ground truth.

    Measured: Through study completion, on average 2 weeks

  3. Sensitivity and Specificity of the Kintsugi Voice Device with Generalized Anxiety Disorder-7 Ground Truth

    Discriminating the presence of a significant anxiety state against the Generalized Anxiety Disorder-7 as the ground truth.

    Measured: Through study completion, on average 2 weeks

Timeline

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

  1. First posted26 Sep 2022
  2. Study start23 Sep 2022
  3. Primary completion5 Jul 2023
  4. Study completion5 Jul 2023

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
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05554042
Status last verified
Feb 2024
First submitted
21 Sep 2022
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: IPD will not be shared with other researchers.

Publications

  • 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

  • Thomas JA, Burkhardt HA, Chaudhry S, Ngo AD, Sharma S, Zhang L, Au R, Hosseini Ghomi R. Assessing the Utility of Language and Voice Biomarkers to Predict Cognitive Impairment in the Framingham Heart Study Cognitive Aging Cohort Data. J Alzheimers Dis. 2020;76(3):905-922. doi: 10.3233/JAD-190783.

    PubMed 32568190

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, Anxiety, 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 11 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 12 Feb 2024. 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 the Kintsugi Voice Device for a Significant Depressive Episode (time frame: Through study completion, on average 2 weeks). The study lists 2 primary outcomes in all. 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 NCT05554042, 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 12 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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