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AI-COA® for Depression and Anxiety Validation Study

This study is testing a new software tool called AI-COA® that uses artificial intelligence to measure how severe depression and anxiety are. The goal is to make sure this tool is accurate and works well for many different people with Major Depressive Disorder (MDD) or a Major Depressive Episode (MDE). You might be able to join if you are 18-65 years old, speak English, have been diagnosed with MDD or MDE, and have recently started a new treatment for depression or anxiety. The study will compare the software's results to what human experts determine, to ensure it's fair and reliable for everyone.

Study design
This is an observational study planning to enroll 650 participants. It is designed to validate a digital tool for measuring depression severity.
What's involved
You will complete standard clinical interviews and self-report measures through secure video conferencing. You will need a computer with a working microphone, webcam, and stable internet.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, HAM-D ICC, is measured at Baseline. Further follow-up is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07279038

Pivotal U.S. Clinical Validation of AI-COA® for Depression and Anxiety

Not Yet Recruiting
Not specifiedAges 18–65Observational
Deliberate Solutions Inc.
~650 participants
Updated 2025-12-12 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HAM-D ICC
Measured over Baseline

Conditions

Depression Disorders
Anxiety Disorders

Explore related trials

Anxiety DisorderUnipolar Depression

NCT07279038

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor College of Medicine

    Houston, Texasno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Marc Aafjes · PRINCIPAL_INVESTIGATOR · Deliberate Solutions Inc.

Who to contact

Eric Storch, PhD
[email protected]
713-798-3579
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

English fluency
18 to 65 years of age.
Diagnosed with MDD or MDE (Includes Remission, HAM-D \<= 7)
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

Exclusion

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
Parkinson's Disease
Stroke
Traumatic Brain Injury
Facial paralysis.
Conditions with vocal cord impact:
Vocal cord injury or cerebrovascular accident or head trauma with residual dysarthria in the past year
Disorders that may impact vocal cords such as acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia
Past or active heavy smokers (an average of \>20 cigarettes per day)
Schizophrenia Spectrum and Other Psychotic Disorders:
Individuals with a current or past diagnosis of Schizophrenia, Schizoaffective Disorder, or other psychotic disorders, including Delusional Disorder and Brief Psychotic Disorder.
Current hypomanic episode as defined by DSM-5 criteria. This includes those with Bipolar I Disorder, Bipolar II Disorder, or Cyclothymic Disorder who are not in a stable mood state at the time of assessment.
Chronic Pain Conditions: Such as fibromyalgia, which may affect facial expressions and vocal tone.
Prosthetic Facial Devices: Could affect facial recognition algorithms. Cosmetic Procedures: Such as Botox injections or facelifts that can impact facial expressions.
Dental Work: Major procedures that might affect speech.
Participants who have previously participated in another research project by Deliberate.

What this trial measures

  • HAM-D ICCBaseline

    Concordance of HAM-D score between model and human raters