Artificial Intelligence for Mental Health Diagnoses and Treatment Plans: A Protocol for Actors and Patients

NCT06417827 | Unknown

• 1 other identifier: SHEBA-23-0356-MW-CTIL
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Diagnosis

Keywords

Artificial intelligence; Mental health diagnosis; Medical technology

Outcome Measures

Primary Outcomes (2)

• Percent agreement of the diagnosis that provide by the psychiatrist and the AI - SPs (actors) part

  The accuracy of diagnosis of the AI and of the psychiatrist will be compared to the gold standard as defined by the training that the actors received. This will be quantified according to if the AI or psychiatrist diagnosis was categorized in the appropriate group: Anxiety disorders, Depressive disorders, Schizophrenia spectrum and other psychotic disorders and Trauma and stressor related disorders

  3 month

• Percent agreement of the diagnosis that provide by the psychiatrist and the AI- Patients part

  The psychiatrist and the AI will both interview the patient and will present a diagnosis. The psychiatrist will be considered as the gold standard, and the AI diagnosis will be compared to those given by the psychiatrist. This will be quantified according to if the AI defines the diagnosis in its appropriate group: Anxiety disorders, Depressive disorders, Schizophrenia spectrum and other psychotic disorders and Trauma and stressor related disorders.

  5 month

Secondary Outcomes (2)

• Percent agreement of the recommendations provided by the AI and the psychiatrists- SPs (actors) part

  3 month

• Percent agreement of the recommendations provided by the AI and by the psychiatrists - Patients part

  5 month

Study Arms (3)

SP patients-actors

EXPERIMENTAL

The actors (n=10) 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 (LIV) 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.

Diagnostic Test: SP patients-actors

Patients

EXPERIMENTAL

The patients (n=150) will be recruited for the study from patients who applied to the psychiatric clinic in Sheba, new patients, old patients and patients on the waiting list. In addition, patients from the various psychiatric departments and the psychiatric and general ER at the Sheba Medical Center - Tel Hashomer. In addition, a recruitment ad will be published on social networks.

Diagnostic Test: Patients

Control group- patients

OTHER

Control group (n=50) Patients who came to the ER at the hospital due to physical complaints, and no psychiatric history. They will be offered to participate in the study and be examined by the AI (LIV) and a psychiatrist while waiting for the ER physician. In addition, a recruitment ad will be published on social networks for patient with no psychiatric conditions.

Diagnostic Test: Control group- patients

Interventions

SP patients-actors DIAGNOSTIC_TEST

SP Actors employed by MesserMSR, the Israeli Center for Medical Simulation, trained to simulate symptoms of psychiatric illnesses.

SP patients-actors

Patients DIAGNOSTIC_TEST

Patients (n=150) examined in the psychiatric division and emergency room (ER) of Sheba Medical center. Or people who applied following an advertisement on social networks.

Patients

Control group- patients DIAGNOSTIC_TEST

Control group (n=50) Patients who came to the ER at the hospital due to physical complaints, and no psychiatric history.

Control group- patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the SPs part:
• Actors SPs employed by "MSR"- the Israeli Center for Medical Simulation, trained to simulate symptoms of psychiatric illnesses.
• Over the age of 18
• Sign an informed consent
• For the patient part:
• Patients arriving for intake at the psychiatric clinic, the various psychiatric departments and the ER at the Sheba Medical Center.
• Patients over the age of 18
• Sign an informed consent

You may not qualify if:

• Patients participating in another study
• Patients under hospitalization order or court order

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center, Psychiatry Department

Ramat Gan, Israel

RECRUITING

MeSH Terms

Interventions

Immunocompromised Host

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

• Mark Weiser, M.D

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Weiser, M.D

CONTACT

+972526666570; Mark.Weiser@sheba.health.gov.il

Hadasa Afgin, B.A

CONTACT

+972552709699; Hadasa.Afgin@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: May 16, 2024
• Study Start: December 12, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 16, 2024

Record last verified: 2023-11

Locations

IL (1)