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Clinical Trials/NCT06464575
NCT06464575
Enrolling By Invitation
Not Applicable

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

Ellipsis Health1 site in 1 country540 target enrollmentJanuary 12, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression/Anxiety
Sponsor
Ellipsis Health
Enrollment
540
Locations
1
Primary Endpoint
Primary Outcome B
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 12, 2024
End Date
June 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Ellipsis Health
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Primary Outcome B

Time Frame: 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

Time Frame: 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 Outcomes

  • Secondary Outcome A(4 days)
  • Secondary Outcome B(4 days)

Study Sites (1)

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