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

NCT06923995 | Recruiting

• 2 other identifiers: SEQUOIA-1U01FD008130
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Depression Disorders; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• HAM-D ICC

  Concordance of HAM-D score between model and human raters

  Between Test and Retest (within 2 days)

Secondary Outcomes (2)

• MADRS ICC

  Between Test and Retest (within 2 days)

• HAM-A ICC

  Between Test and Retest (within 2 days)

Study Arms (4)

A1: AI interview first, and measures set 1

EXPERIMENTAL

A1: AI interview first, and measures set 1

Other: AI-driven clinical interview

A2: AI interview first, and measures set 2

EXPERIMENTAL

A2: AI interview first, and measures set 2

Other: AI-driven clinical interview

B1: AI interview second, and measures set 1

EXPERIMENTAL

Other: AI-driven clinical interview

B2: A1: AI interview second and measures set 2

EXPERIMENTAL

Other: AI-driven clinical interview

Interventions

AI-driven clinical interview OTHER

AI-driven clinical interview

A1: AI interview first, and measures set 1; A2: AI interview first, and measures set 2; B1: AI interview second, and measures set 1; B2: A1: AI interview second and measures set 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English fluency
• 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
• Access to a laptop or other computer with a well functioning microphone and webcam, and a stable Internet connection
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Resides in the United States at the time of consent and during completion of study

You may not qualify if:

• 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
• Concurrent medication/treatment:
• Receiving any fast-acting treatment for depression or anxiety (e.g. ketamine, psychedelics, deep brain stimulation, etc.) in between initial baseline assessment (A1) and Restest (A2) , or in between Follow up assessment (B1) and Retest (B2)
• Anxiolytics: Use of benzodiazepines or other anxiety-reducing medications that could affect speech or motor activity, within the past 4 weeks.
• Antipsychotics and Mood Stabilizers: Medications that can alter cognitive and motor functions, within the past 6 weeks.
• Stimulants: Use of medications like methylphenidate or amphetamines that affect energy levels and behavior, within the past 2 weeks
• Epilepsy medication: seizure activity or medication side effects that may alter behavior, within the past 4 weeks.
• Any history or evidence of any of the following conditions:
• Neurodevelopmental, Neurocognitive, Neurodegenerative or movement disorders including, but not limited to:
• Tourette's syndrome
• Multiple Sclerosis
• Amyotrophic Lateral Sclerosis

Sponsors & Collaborators

• Deliberate Solutions Inc.: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Marc Aafjes

  Deliberate Solutions Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Storch, PhD

CONTACT

713-798-3579; research@sequoiastudy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 11, 2025
• Study Start: September 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)