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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Health Questionnaire-9 | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include males and females fluent in English over the age of 18 in the United States and Canada. Participants both with and without a personal history of depression and/or anxiety are eligible to participate in the study. Participants will require access to a laptop, smartphone, or tablet with a functioning microphone and provide stated willingness to comply with all study procedures and availability for the duration of the study. Participants with a visual or motor impairment that would make it difficult to use the web-based survey will be excluded from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Mei-Hsin Cheng, PhD | Kintsugi Mindful Wellness, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kintsugi Mindful Wellness, Inc. | Berkeley | California | 94705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32790653 | Background | 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. | |
| Background | ADAA. Facts & statistics: Anxiety and Depression Association of America. Retrieved March 05, 2021, from https://adaa.org/about-adaa/press-room/facts-statistics | ||
| 32128436 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2021 | Jun 29, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 14, 2021 | Jul 8, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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| Generalized Anxiety Disorder-7 | Diagnostic Test | 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. |
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| Hamilton Depression Rating Scale | Diagnostic Test | 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. |
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| Hamilton Anxiety Rating Scale | Diagnostic Test | 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. |
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