Comparison of Vocal Biomarkers for Depression and Anxiety to Formal Clinical Assessments

NCT ID: NCT06464575

Last Updated: 2024-06-18

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-12

Study Completion Date

2024-06-30

Brief Summary

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Participants will be recruited to complete self reported surveys normally used as standards of care for screening and monitoring depression and anxiety symptom severity, provide a voice sample composed of an answer to open ended questions and then be assessed by a mental health professional using structured and clinically validated assessment tools for depression and anxiety. Their voice will be analyzed by machine learning models that predict the severity of depression and anxiety symptoms. The models' performance will be compared to the clinician assessments and how that correlation compares to a similar comparison between the clinician assessments with the self reported surveys. It is hypothesized that the performance of the machine learning models in assessing the severity of depression and anxiety symptoms is no worse than the self reported surveys when both are compared to clinician assessments. It is also hypothesized that presence or absence of the diagnoses of Major Depressive Disorder and Generalized Anxiety Disorder can be predicted better than chance by the analysis of the participant's voice sample using machine learning models.

Detailed Description

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Conditions

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Depression/Anxiety

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Native speaker or conversant in English
* Access to smartphone or computer with microphone
* Provision of esigned and dated informed consent form
* Willingness to adhere to the study protocol

Exclusion Criteria

* Speech impairments or other conditions that impact their ability to speak clearly
* Under the influence of recreational drugs or alcohol
* Ill or experiencing heavy allergies or temporary conditions affecting respiration, voice, or speaking.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ellipsis Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ellipsis Health

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00070013

Identifier Type: -

Identifier Source: org_study_id

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