Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
19533 participants
OBSERVATIONAL
2021-09-14
2022-09-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Main Study Cohort
A web-based audio recording tool will be used to record voice sample answering the prompt, "How are you feeling today?" Participants are asked to speak for 1-minute. Following the recording, participants are asked to complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 questions.
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.
Selected Self-Reported Depression Cohort
The Researcher will review Patient Health Questionnaire-9 scores of all the participants and select the subset that self-reported a scored greater than 20, on a scale from 0 to 27. Participants will be approached via email to complete an additional administration of the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 questionnaires and be offered resources for depression and anxiety and how to set up an appointment with a mental health professional.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Motor impairment that would make it difficult for the participant to use the web-based survey
18 Years
ALL
No
Sponsors
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Kintsugi Mindful Wellness, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mei-Hsin Cheng, PhD
Role: PRINCIPAL_INVESTIGATOR
Kintsugi Mindful Wellness, Inc.
Locations
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Kintsugi Mindful Wellness, Inc.
Berkeley, California, United States
Countries
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References
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Czeisler ME, Lane RI, Petrosky E, Wiley JF, Christensen A, Njai R, Weaver MD, Robbins R, Facer-Childs ER, Barger LK, Czeisler CA, Howard ME, Rajaratnam SMW. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic - United States, June 24-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1049-1057. doi: 10.15585/mmwr.mm6932a1.
ADAA. Facts & statistics: Anxiety and Depression Association of America. Retrieved March 05, 2021, from https://adaa.org/about-adaa/press-room/facts-statistics
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.
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.
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.
Espinola, CW, Gomes, JC, Pereira, JMS et. al. Detection of major depressive disorder using vocal acoustic analysis and machine learning-an exploratory study. Res. Biomed. Eng. 2021; 37: 53-64.
Wang J, Zhang L, Liu T, Pan W, Hu B, Zhu T. Acoustic differences between healthy and depressed people: a cross-situation study. BMC Psychiatry. 2019 Oct 15;19(1):300. doi: 10.1186/s12888-019-2300-7.
He L, Cao C. Automated depression analysis using convolutional neural networks from speech. J Biomed Inform. 2018 Jul;83:103-111. doi: 10.1016/j.jbi.2018.05.007. Epub 2018 May 29.
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.
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.
Stassen HH, Bomben G, Gunther E. Speech characteristics in depression. Psychopathology. 1991;24(2):88-105. doi: 10.1159/000284700.
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.
Low LS, Maddage NC, Lech M, Sheeber LB, Allen NB. Detection of clinical depression in adolescents' speech during family interactions. IEEE Trans Biomed Eng. 2011 Mar;58(3):574-86. doi: 10.1109/TBME.2010.2091640. Epub 2010 Nov 11.
Tuka A, Mohammad G, and James G. Detecting Depression with Audio/Text Sequence Modeling of Interviews. Interspeech. 2018; 2522.
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.
Xu, M, Duan, LY, Cai, J, Chia, LT, Xu, C, & Tian, Q. HMM-based audio keyword generation. In Pacific-Rim Conference on Multimedia. 2004; November: 566-574. Springer, Berlin, Heidelberg.
Aizawa IK, Nakamura Y, Satoh S, et. al. Advances in Multimedia Information Processing - PCM 2004: 5th Pacific Rim Conference on Multimedia. Springer. ISBN 978-3-540-23985-7.
Crockford, D. (2001, April). Introducing JSON. JavaScript Object Notation. https://www.json.org/json-en.html
HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
Trajkovic G, Starcevic V, Latas M, Lestarevic 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.
HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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2021/08/25
Identifier Type: -
Identifier Source: org_study_id
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