Voice Biomarkers Predictive of Depression and Anxiety

Healthy Clinical Trial

Official title:

Voice Biomarkers Predictive of Depression and Anxiety: An Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455905
• Other study ID #: 2021/08/25
• Status: Completed
• Start date: September 14, 2021
• Est. completion date: September 11, 2022

Study information

• Verified date: September 2022
• Source: Kintsugi Mindful Wellness, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to collect data to improve the sensitivity and specificity of Kintsugi Voice's (formerly KiVATM) predictions on audio files. A web-based audio recording tool will be used to record voice sample and ask participants the PHQ-9 and GAD-7 questions. A voluntary subset of participants will then be assessed by mental health professionals with the Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) scores.

Description:

Participants will be recruited via various online mediums to participate in a voluntary observational study. Completing the consent and survey on their smart-phone, tablet, or computer, the participant will be asked to provide a 1-minute response to an audio prompt "How was your day?" After recording their response, the participant will be asked to complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 measures independently.

In a second voluntary phase of the study, participants who indicated a score higher than 20, will be contacted by the research team via email to determine if they are interested in a voluntary follow-up to their initial study participation. Participants who would like to take part in the additional survey will complete additional voice recording responses to prompts and complete the Patient History Questionnaire and Generalized Anxiety Disorder-7. These participants will be contacted by a Mental Health Professional to discuss seeking mental health resources and clinicians, as well as, complete the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale via the telephone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19533
• Est. completion date: September 11, 2022
• Est. primary completion date: September 11, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult males and or females over the age of 18 at the time of informed consent. Adults with a known history of depression and/or anxiety and adults without a known history of depression and/or anxiety will be included in this study.

• Access to a laptop, smart-phone or tablet with a functioning microphone

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Fluency in English

Exclusion Criteria:

• Visual impairment that would make it difficult for the participant to see the web-based survey

• Motor impairment that would make it difficult for the participant to use the web-based survey

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder
• Healthy
• Mental Health Wellness 1

Intervention

Diagnostic Test:
• Patient Health Questionnaire-9
The Patient Health Questionnaire-9 is a nine question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Patient Health Questionnaire-9 is scored from 0 to 27 where higher scores are associated with more severe depression.
• Generalized Anxiety Disorder-7
The Generalized Anxiety Disorder-7 is a seven question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Generalized Anxiety Disorder-7 is scored from 0 to 21 where higher scores are associated with more severe anxiety.
• Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale is administered by a mental health profession and includes twenty-one questions asking about how the participant has been feeling in the past week. The Hamilton Depression Rating Scale is scored from 0 to 45 where higher scores are associated with more severe depression.
• Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale is administered by a mental health profession and includes fourteen questions asking about how the participant has been feeling in the past week. The Hamilton Anxiety Rating Scale is scored from 0 to 56 where higher scores are associated with more severe anxiety.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Kintsugi Mindful Wellness, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (21)

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Pan W, Flint J, Shenhav L, Liu T, Liu M, Hu B, Zhu T. Re-examining the robustness of voice features in predicting depression: Compared with baseline of confounders. PLoS One. 2019 Jun 20;14(6):e0218172. doi: 10.1371/journal.pone.0218172. eCollection 2019. — View Citation

Stassen HH, Bomben G, Günther E. Speech characteristics in depression. Psychopathology. 1991;24(2):88-105. — View Citation

Taguchi T, Tachikawa H, Nemoto K, Suzuki M, Nagano T, Tachibana R, Nishimura M, Arai T. Major depressive disorder discrimination using vocal acoustic features. J Affect Disord. 2018 Jan 1;225:214-220. doi: 10.1016/j.jad.2017.08.038. Epub 2017 Aug 16. — View Citation

Trajkovic G, Starcevic V, Latas M, Leštarevic M, Ille T, Bukumiric Z, Marinkovic J. Reliability of the Hamilton Rating Scale for Depression: a meta-analysis over a period of 49 years. Psychiatry Res. 2011 Aug 30;189(1):1-9. doi: 10.1016/j.psychres.2010.12.007. Epub 2011 Jan 26. — View Citation

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Yi H, Smiljanic R, Chandrasekaran B. The Effect of Talker and Listener Depressive Symptoms on Speech Intelligibility. J Speech Lang Hear Res. 2019 Nov 18;62(12):4269-4281. doi: 10.1044/2019_JSLHR-S-19-0112. Print 2019 Dec 18. — 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 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale	Participants will be interviewed by mental health professionals using the clinically validated Hamilton Depression Rating Scale, which has a score range of 0 to 54, where higher scores are associated with higher severity of depression.	Through study completion, on average 12months
Primary	Hamilton Anxiety Rating Scale	Participants will be interviewed by mental health professionals using the clinically validated Hamilton Anxiety Rating Scale, which has a score range of 0 to 56, where higher scores are associated with higher severity anxiety.	Through study completion, on average 12 months