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

NCT06464575 | Enrolling By Invitation

• 1 other identifier: Pro00070013
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression/Anxiety

Keywords

Vocal biomarker; Depression; Anxiety; Structured clinical assessment

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (2)

• Secondary Outcome A

  4 days

• Secondary Outcome B

  4 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\~540 individuals aged 18 and above, of any gender, race, culture, ethnicity, sexual orientation or educational level residing anywhere in the United States.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ellipsis Health: lead

Study Sites (1)

Ellipsis Health

San Francisco, California, 94104, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: January 12, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-05

Locations

US (1)