AI-COA®: using AI to measure depression and anxiety severity from video interviews

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional project uses an AI-based Clinical Outcome Assessment (AI-COA®) that analyzes recorded video interviews to generate symptom severity scores for depression and anxiety. Adults aged 18–65 with a baseline HAM-D17 > 10 who have begun a new treatment within the prior 2–3 weeks and who can use a webcam and microphone are enrolled and complete remote interviews and online surveys. The AI outputs are compared with standard clinician-based ratings and symptom measures to determine consistency and objectivity across participants. The AI-COA® approach has been accepted into the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) program as a novel measurement method.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* 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 Criteria:

* 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.

Where it's running

• Baylor College of Medicine
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Marc Aafjes — Deliberate Solutions Inc.
• Study coordinator: Eric Storch, PhD
• Email: research@sequoiastudy.com
• Phone: 713-798-3579

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fluoxetine added to immunotherapy for advanced liver and gallbladder cancer with depression or anxiety

  This trial will test whether adding the antidepressant fluoxetine to standard PD-1/PD-L1 immunotherapy helps people with advanced liver or gallbladder cancers who also have depression or anxiety.

  Recruiting Phase 2 First Affiliated Hospital of Wenzhou Medical University · Wenzhou, Zhejiang · NCT07174947

• Improving patient engagement in collaborative care for anxiety and depression

  This study is testing a new way to involve patients more in their anxiety and depression treatment by using their personal goals to see if it makes them and their doctors happier with the care they receive.

  Recruiting at 6 sites Dartmouth-Hitchcock Medical Center · Concord, New Hampshire and 5 other locations · NCT06898593

• Understanding anxiety, depression, and bipolar disorder over time in China

  This study tests how anxiety, depressive, and bipolar symptoms change over three years to find patterns that help with earlier recognition and prediction in people aged 12–55.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07903246

• See if personalized CBM-I can help anxious kids ages 10–17

  Aimed at youth with Generalized, Separation, or Social Anxiety, the study tests a personalized cognitive bias modification for interpretation (CBM-I) to see if it reduces threat-focused thinking and anxiety.

  Recruiting University of Denver · Denver, Colorado · NCT07818876

• Expectancy Focused Exposure for Anxiety Disorders

  We test whether Expectancy Focused Exposure helps reduce anxiety symptoms and prevent fear from coming back better than Anxiety Focused Exposure in adults with anxiety disorders.

  Recruiting University of Chile · Santiago, Santiago Metropolitan · NCT07753330

• Does extra family income improve child mental health and brain biology in low-income families?

  This study tests whether three years of extra income for parents can improve their child’s mental health and neuroimmune function.

  Recruiting Northwestern University · Evanston, Illinois · NCT07641244

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.