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

Depression/Anxiety Clinical Trial

Official title:

Prediction of a Structured Clinical Assessment by Patient Reported Outcomes and Machine Learning Algorithms: A Comparative Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06464575
• Other study ID #: Pro00070013
• Status: Enrolling by invitation
• Start date: January 12, 2024
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: Ellipsis Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 540
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression/Anxiety
• Depressive Disorder

Locations

Country	Name	City	State
United States	Ellipsis Health	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Ellipsis Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome A	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.	4 days
Primary	Primary Outcome B	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.	4 days
Secondary	Secondary Outcome A	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.	4 days
Secondary	Secondary Outcome B	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.	4 days