Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06923995

Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity

Led by Deliberate Solutions Inc. · Updated on 2025-11-13

120

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

D

Deliberate Solutions Inc.

Lead Sponsor

B

Baylor College of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

The SEQUOIA-1 study evaluates the effectiveness of Artificial Intelligence (AI) in measuring depression and anxiety severity in adults. Investigators from Deliberate Solutions, Inc. and Baylor College of Medicine are conducting this study to determine whether AI can provide reliable clinical assessments of mood and anxiety disorders. In clinical trials for new depression and anxiety treatments, human clinicians typically conduct interviews to evaluate participants' symptoms. These assessments are critical but may vary based on the clinician's experience or interview style, potentially affecting the reliability of research findings. To address this challenge, the study team developed an AI-based Clinical Outcome Assessment tool, called AICOA®, which analyzes video interviews to measure symptoms of depression and anxiety consistently and objectively. AI-COA® has been accepted by the U.S. Food and Drug Administration (FDA) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. The primary objectives of the SEQUOIA-1 study are to collect additional data to improve model accuracy and to evaluate model performance across diverse demographic groups. The study also pilots the use of an AI interviewer-an interactive digital agent-to conduct remote assessments. During the study, participants will complete questionnaires about their symptoms and perform brief tasks. Participants will also provide feedback regarding their experience interacting with the AI interviewer. All assessments will be securely video-recorded. Recorded videos will be analyzed by AICOA® to determine depression and anxiety symptom severity. These results will be compared to assessments conducted by human clinicians. The development and validation of reliable, AI-driven assessment tools through this study aim to enhance the accuracy of mental health evaluations, potentially improving the testing and approval processes for new treatments targeting depression and anxiety.

CONDITIONS

Official Title

Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fluent in English
  • Between 18 and 65 years old
  • HAM-D 17 score greater than 10
  • Starting or started a new treatment for depression or anxiety within 2 to 3 weeks of enrollment
  • Access to a laptop or computer with a working microphone and webcam, and stable internet
  • Willingness to comply with all study procedures and available for the study duration
  • Resides in the United States at consent and during study participation
Not Eligible

You will not qualify if you...

  • Cognitive impairment limiting ability to give informed consent or authorization
  • Vulnerable or protected populations, such as prisoners
  • Impairments preventing completion of online surveys or clinician interviews (e.g., visual, motor, hearing impairments)
  • Acute intoxication at time of assessments
  • Use of fast-acting treatments for depression or anxiety between baseline and retest assessments
  • Use of benzodiazepines or other anxiety-reducing medications affecting speech or motor activity within past 4 weeks
  • Use of antipsychotics or mood stabilizers affecting cognition or motor function within past 6 weeks
  • Use of stimulants affecting energy or behavior within past 2 weeks
  • Epilepsy medication use or seizure activity affecting behavior within past 4 weeks
  • History or evidence of neurodevelopmental, neurocognitive, neurodegenerative, or movement disorders including Tourette's syndrome, multiple sclerosis, ALS, Parkinson's disease, stroke, traumatic brain injury, facial paralysis
  • Conditions affecting vocal cords such as recent vocal cord injury, laryngitis, vocal cord paresis or paralysis, spasmodic dysphonia
  • Past or active heavy smoking (more than 20 cigarettes per day)
  • Current or past diagnosis of schizophrenia spectrum or other psychotic disorders
  • Current hypomanic episode or unstable bipolar mood state
  • Chronic pain conditions like fibromyalgia affecting facial expressions or vocal tone
  • Use of prosthetic facial devices or cosmetic procedures impacting facial recognition
  • Major dental work affecting speech
  • Previous participation in another Deliberate research project

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

E

Eric Storch, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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