Viewing Study NCT06417827



Ignite Creation Date: 2024-05-19 @ 5:34 PM
Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06417827
Status: RECRUITING
Last Update Posted: 2024-05-16
First Post: 2024-04-10

Brief Title: Artificial Intelligence for Mental Health Diagnoses and Treatment Plans A Protocol for Actors and Patients
Sponsor: Sheba Medical Center
Organization: Sheba Medical Center

Study Overview

Official Title: Artificial Intelligence for Mental Health Diagnoses and Treatment Plans A Protocol for Actors and Patients
Status: RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Artificial intelligence AI is becoming prevalent in modern medicine and psychiatry AI is based on a wide variety of computer algorithms classified under machine learning ML

The purpose of the present study is to evaluate the potential for mental health diagnosis using AI

In the first part of the study the AI will conduct an interview with standardized patients SP actors presenting a psychiatric illness The AI will present a differential diagnosis and treatment plan Immediately afterward the actors will be interviewed by a board-certified psychiatrist who will also give a differential diagnosis and a treatment plan The results of the AI and psychiatrist will be compared

In the second part of the study AI will examine patients coming for consultation by a psychiatrist in the inpatient units outpatient units or in the emergency room ER at Sheba Medical center The AI results will be compered to the psychiatrist diagnosis
Detailed Description: Procedure

In the firs part of the study The AI will conduct an interview with standardized SP patients actors presenting a psychiatric illness The actors will be trained in one of 5 scenarios depression anxiety PTSD with cannabis abuse psychosis and control patients with no diagnosis Each scenario will have 2 levels of severity The actors will present demographic and medical backgrounds symptoms and signs including disorders of thought and affect based on the interview the AI will present a differential diagnosis and treatment plan Immediately afterward the actors will be interviewed by a board-certified psychiatrist who will also give a differential diagnosis and a treatment plan The results of the AI and psychiatrist will be compared

In the second part of the study AI will examine patients patients treated in the Division of Psychiatry patients who applied for treatment in the psychiatric clinic but are not yet treated there and patients treated in the psychiatric emergency room ER in Sheba Medical center In additional a recruitment ad will be published in the media and on social networks to include patients who will come in specifically to participate in the study

The patient will give informed consent and will be interviewed by AI The interview will be done either digitally or will use voice-to-text and text-to-voice technology that will allow the patient to speak with the computer instead of typing questions into the computer Future studies not included in the current proposal will use voice analysis face recognition and computerized emotion recognition as part of AI

Participants

Actors SPs n10 each time employed by MSR- the Israeli Center for Medical Simulation trained to simulate symptoms of psychiatric illnesses
Board-certified Psychiatrists from the Drora and Pinchas Zachai Division of Psychiatry in the Sheba Medical Center
Patients n150 examined in the psychiatric division and emergency room ER of Sheba Or patient that recruited from the media
Control group n50 Patients who came to the ER at the hospital due to physical problems and no psychiatric history They will be offered while waiting for the doctor to participate in the study and be examined by the AI and a psychiatrist

Outcome

The primary outcome of the study will be a comparison of the interviews differential diagnoses and recommendations for treatment assigned by the AI with those assigned by the board-certified psychiatrist The rates of agreement will be the outcome of interest

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None