Evaluating AI-COA® for Depression and Anxiety Assessment
This study is evaluating a digital tool called AI-COA® that uses artificial intelligence (AI) to measure the severity of depression and anxiety. Researchers want to see if AI-COA® can consistently and accurately assess symptoms compared to standard evaluations by doctors. You might be able to join if you are 18-65 years old, speak English, have a certain level of depression (HAM-D 17 > 10), and have recently started a new treatment for depression or anxiety. The study is looking for 150 participants and will compare the AI-COA® tool's results against clinician ratings over 12 weeks to see how well it tracks changes in symptoms.
- Study design
- This is an observational study involving about 150 participants, comparing an AI tool's performance against standard clinician ratings.
- What's involved
- You would need access to a computer with a working microphone and webcam, and a stable internet connection. You would also need to be available for the duration of the study, which compares assessments over 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured within 2 days for the HAM-D ICC, and the study compares performance over a 12-week period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07279025
Validate the Temporal Stability and Responsiveness of AI-COA® for Depression and Anxiety
Not Yet Recruiting
Not specifiedAges 18–65ObservationalDeliberate Solutions Inc.
~150 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 Between Test and Retest (within 2 days)
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Marc Aafjes · PRINCIPAL_INVESTIGATOR · Deliberate Solutions Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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 ICCBetween Test and Retest (within 2 days)
Concordance of HAM-D score between model and human raters