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Completed

NCT Number: NCT05455905

Voice Biomarkers Predictive of Depression and Anxiety

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Healthy Mental Disorders Mental Health Wellness 1 Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kintsugi Mindful Wellness, Inc.

Berkeley, California, 94705, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PHQ-9

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.

Other names: GAD-7

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.

Other names: HDRS, HAM-D

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.

Other names: HARS, HAM-A

Primary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: Through study completion, on average 12months

    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.

  2. Hamilton Anxiety Rating Scale

    Time frame: Through study completion, on average 12 months

    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.

Sponsors and collaborators

Lead sponsor

Kintsugi Mindful Wellness, Inc.

Industry

Registry information

Official study title

Voice Biomarkers Predictive of Depression and Anxiety: An Observational Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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