Validate the Temporal Stability and Responsiveness of AI-COA® for Depression and Anxiety

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorDeliberate Solutions Inc.

About this trial

This study evaluates the reliability and responsiveness of the AI-COA®, a digital tool designed to assess the severity of depression and anxiety. The study compares the tool's performance against standard clinician ratings over 12 weeks to determine its consistency and sensitivity to symptom changes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English fluency

18 to 65 years of age.

HAM-D 17 > 10

Starting, or has started, a new treatment for depression or anxiety within 2-3 weeks of enrollment

Disqualifiers

Any cognitive impairment that limits ability to provide informed consent or authorization

Vulnerable or protected populations (e.g. prisoners)

Impairment that would prevent participants from completing an online survey and/or engaging in clinician assessment interviews (e.g., visual impairment, motor impairment, hearing impairment)

Acute intoxication at the time of the assessments

Trial population

patients with MDD or MDE

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

HAM-D ICC

Concordance of HAM-D score between model and human raters

Time frame
Between Test and Retest (within 2 days)

Secondary outcomes

1

MADRS ICC

Concordance of MADRS score between model and human raters

Time frame
Between Test and Retest (within 2 days)
2

HAM-A ICC

Concordance of HAM-A score between model and human raters

Time frame
Between Test and Retest (within 2 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Deliberate Solutions Inc.

Lead sponsor

Baylor College of Medicine

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: