Clinical trial for Depression Disorders
Official title Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity
ClinicalTrials.gov ID: NCT06923995
What this study is testing
- What it's testing
- The study wants to see if an artificial‑intelligence system can reliably assess how severe a person's depression or anxiety is, compared with usual clinician interviews.
- Who it's for
- Adults who have been diagnosed with a depression or anxiety disorder.
- What's involved
- Participants will answer symptom questionnaires, do short tasks, and talk to a digital AI interviewer while being video‑recorded. The videos are analyzed by the AI tool, and participants also give feedback about the AI experience.
- Time commitment
- The study lasts for a few visits over several weeks, with each visit including the video interview and questionnaires.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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...
- Acute intoxication at the time of the assessments
- Receiving any fast-acting treatment for depression or anxiety (e.g.
- Anxiolytics: Use of benzodiazepines or other anxiety-reducing medications that could affect speech or motor activity, within the past 4 weeks.
See the full eligibility 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
- 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
- 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...
- 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.
- Tourette's syndrome
- Multiple Sclerosis
- Amyotrophic Lateral Sclerosis
- Parkinson's Disease
- Stroke
- Traumatic Brain Injury
- Facial paralysis.
- 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)
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.