Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity
NCT ID: NCT06923995
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
120 participants
INTERVENTIONAL
2025-09-01
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In clinical trials for new depression and anxiety treatments, human clinicians typically conduct interviews to evaluate participants' symptoms. These assessments are critical but may vary based on the clinician's experience or interview style, potentially affecting the reliability of research findings.
To address this challenge, the study team developed an AI-based Clinical Outcome Assessment tool, called AICOA®, which analyzes video interviews to measure symptoms of depression and anxiety consistently and objectively. AI-COA® has been accepted by the U.S. Food and Drug Administration (FDA) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program.
The primary objectives of the SEQUOIA-1 study are to collect additional data to improve model accuracy and to evaluate model performance across diverse demographic groups. The study also pilots the use of an AI interviewer-an interactive digital agent-to conduct remote assessments.
During the study, participants will complete questionnaires about their symptoms and perform brief tasks. Participants will also provide feedback regarding their experience interacting with the AI interviewer.
All assessments will be securely video-recorded. Recorded videos will be analyzed by AICOA® to determine depression and anxiety symptom severity. These results will be compared to assessments conducted by human clinicians.
The development and validation of reliable, AI-driven assessment tools through this study aim to enhance the accuracy of mental health evaluations, potentially improving the testing and approval processes for new treatments targeting depression and anxiety.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A1: AI interview first, and measures set 1
A1: AI interview first, and measures set 1
AI-driven clinical interview
AI-driven clinical interview
A2: AI interview first, and measures set 2
A2: AI interview first, and measures set 2
AI-driven clinical interview
AI-driven clinical interview
B1: AI interview second, and measures set 1
AI-driven clinical interview
AI-driven clinical interview
B2: A1: AI interview second and measures set 2
AI-driven clinical interview
AI-driven clinical interview
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AI-driven clinical interview
AI-driven clinical interview
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Deliberate Solutions Inc.
INDUSTRY
Baylor College of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marc Aafjes
Role: PRINCIPAL_INVESTIGATOR
Deliberate Solutions Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Baylor College of Medicine
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SEQUOIA-1
Identifier Type: -
Identifier Source: org_study_id