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

NCT07279025 | Not Yet Recruiting

• 1 other identifier: SEQUOIA-2
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression Disorders; Anxiety Disorders

Keywords

depression assessment; anxiety assessment

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)

Eligibility Criteria

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

Study Population

patients with MDD or MDE

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
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

audiovideo recordings

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 12, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)