Status:
RECRUITING
Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity
Lead Sponsor:
Deliberate Solutions Inc.
Collaborating Sponsors:
Baylor College of Medicine
Conditions:
Depression Disorders
Anxiety Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06923995
Start Date
September 1 2025
End Date
February 28 2026
Last Update
November 13 2025
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030