Kintsugi Voice Device Study

Depression, Anxiety Clinical Trial

Official title:

Kintsugi Voice Device Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05554042
• Status: Completed
• Start date: September 23, 2022
• Est. completion date: July 5, 2023

Study information

• Verified date: February 2024
• Source: Kintsugi Mindful Wellness, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

Diagnostic Test:
• Kintsugi Voice Device
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.

Locations

Country	Name	City	State
United States	Kintsugi Mindful Wellness, Inc.	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
Kintsugi Mindful Wellness, Inc.	Vituity

Country where clinical trial is conducted

United States, 

References & Publications (31)

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. — View Citation

Deng K, Li Y, Zhang H, Wang J, Albin RL, Guan Y. Heterogeneous digital biomarker integration out-performs patient self-reports in predicting Parkinson's disease. Commun Biol. 2022 Jan 17;5(1):58. doi: 10.1038/s42003-022-03002-x. — View Citation

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

Di Y, Wang J, Liu X, Zhu T. Combining Polygenic Risk Score and Voice Features to Detect Major Depressive Disorders. Front Genet. 2021 Dec 20;12:761141. doi: 10.3389/fgene.2021.761141. eCollection 2021. — View Citation

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

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. — View Citation

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

Fagherazzi G, Fischer A, Ismael M, Despotovic V. Voice for Health: The Use of Vocal Biomarkers from Research to Clinical Practice. Digit Biomark. 2021 Apr 16;5(1):78-88. doi: 10.1159/000515346. eCollection 2021 Jan-Apr. — View Citation

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

Greden JF, Albala AA, Smokler IA, Gardner R, Carroll BJ. Speech pause time: a marker of psychomotor retardation among endogenous depressives. Biol Psychiatry. 1981 Sep;16(9):851-9. — View Citation

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. — View Citation

Kraepelin E. Manic Depressive Insanity and Paranoia. The Journal of Nervous and Mental Disease. 1921;53(4). https://journals.lww.com/jonmd/Fulltext/1921/04000/Manic_Depressive_Insanity_and_Paranoia.57.aspx

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. — View Citation

Lin H, Karjadi C, Ang TFA, Prajakta J, McManus C, Alhanai TW, Glass J, Au R. Identification of digital voice biomarkers for cognitive health. Explor Med. 2020;1:406-417. doi: 10.37349/emed.2020.00028. Epub 2020 Dec 31. — View Citation

Low DM, Bentley KH, Ghosh SS. Automated assessment of psychiatric disorders using speech: A systematic review. Laryngoscope Investig Otolaryngol. 2020 Jan 31;5(1):96-116. doi: 10.1002/lio2.354. eCollection 2020 Feb. — View Citation

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

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

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. — View Citation

Mundt JC, Vogel AP, Feltner DE, Lenderking WR. Vocal acoustic biomarkers of depression severity and treatment response. Biol Psychiatry. 2012 Oct 1;72(7):580-7. doi: 10.1016/j.biopsych.2012.03.015. Epub 2012 Apr 26. — View Citation

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. — View Citation

Ozkanca Y, Ozturk MG, Ekmekci MN, Atkins DC, Demiroglu C, Ghomi RH. Depression Screening from Voice Samples of Patients Affected by Parkinson's Disease. Digit Biomark. 2019 May-Aug;3(2):72-82. doi: 10.1159/000500354. Epub 2019 Jun 12. — View Citation

Salekin A, Eberle JW, Glenn JJ, Teachman BA, Stankovic JA. A Weakly Supervised Learning Framework for Detecting Social Anxiety and Depression. Proc ACM Interact Mob Wearable Ubiquitous Technol. 2018 Jun;2(2):81. doi: 10.1145/3214284. — View Citation

Shin D, Cho WI, Park CHK, Rhee SJ, Kim MJ, Lee H, Kim NS, Ahn YM. Detection of Minor and Major Depression through Voice as a Biomarker Using Machine Learning. J Clin Med. 2021 Jul 8;10(14):3046. doi: 10.3390/jcm10143046. — View Citation

Singh R, Baker JT, Pennant L, Morency LP. Deducing the severity of psychiatric symptoms from the human voice. ArXiv. 2017;abs/1703.05344.

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. — View Citation

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. — View Citation

Szabadi E, Bradshaw CM, Besson JA. Elongation of pause-time in speech: a simple, objective measure of motor retardation in depression. Br J Psychiatry. 1976 Dec;129:592-7. doi: 10.1192/bjp.129.6.592. — View Citation

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. — View Citation

Tracy JM, Ozkanca Y, Atkins DC, Hosseini Ghomi R. Investigating voice as a biomarker: Deep phenotyping methods for early detection of Parkinson's disease. J Biomed Inform. 2020 Apr;104:103362. doi: 10.1016/j.jbi.2019.103362. Epub 2019 Dec 19. — View Citation

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. — View Citation

Zhang L, Duvvuri R, Chandra KKL, Nguyen T, Ghomi RH. Automated voice biomarkers for depression symptoms using an online cross-sectional data collection initiative. Depress Anxiety. 2020 Jul;37(7):657-669. doi: 10.1002/da.23020. Epub 2020 May 7. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, on average 2 weeks
Primary	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	Through study completion, on average 2 weeks
Secondary	Proportion of Indeterminate Outputs	Measure the proportion of participants who complete the study and the device output is Indeterminate.	Through study completion, on average 2 weeks.
Secondary	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.	Through study completion, on average 2 weeks
Secondary	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.	Through study completion, on average 2 weeks