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

• Conditions: Depression/Anxiety

• Registration Number: NCT06464575
• Lead Sponsor: Ellipsis Health

Brief Summary

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

Not available

Study Timeline

• Study Start: 2024-01-12
• Status Verified: 2024-05
• Primary Completion: 2024-06
• Study Completion: 2024-06
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 540

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
• To participate in the subsequent clinical interview portion of this study in addition to the above inclusion criteria, a participant must provide an evaluable and qualified voice sample.

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome B	4 days	Extent of categorical agreement, measured in weighted kappa, between Ellipsis Health Software as a Medical Device severity of anxiety and clinician's rating of severity of anxiety.
Primary Outcome A	4 days	Extent of categorical agreement, measured in weighted kappa, between Ellipsis Health Software as a Medical Device severity of depression and clinician's rating of severity of depression.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome A	4 days	Extent of agreement of presence, measured in the Equal Error Rate on the Receiver Operating Characteristic curve, between Ellipsis Health Software aa a Medical Device detection of Major Depressive Disorder and clinician's assessment for the diagnosis of Major Depressive Disorder, as expressed as Sensitivity and Specificity.
Secondary Outcome B	4 days	Extent of agreement of presence, measured in the Equal Error Rate on the Receiver Operating Characteristic curve, between Ellipsis Health Software as a Medical Device detection of Generalized Anxiety Disorder and clinician's assessment for the diagnosis of Generalized Anxiety Disorder, as expressed as Sensitivity and Specificity.

Trial Locations

Locations (1)

Ellipsis Health; 🇺🇸 San Francisco, California, United States