Mental Health DiagnosisNCT06417827
Artificial Intelligence for Mental Health Diagnoses and Treatment Plans: A Protocol for Actors and Patients
A study testing SP patients-actors and Patients in people with Mental Health Diagnosis, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Diagnosis
- What is being tested?
- SP patients-actors and Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients participating in another study
- Patients under hospitalization order or court order
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center, Psychiatry Department
Ramat Gan
Mark Weiser, MD, +972-3-5303773, mweiser@netvision.net.il
Hadasa Afgin, B.A, +972552709699, Hadasa.Afgin@sheba.health.gov.il
About this study
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.
Read more
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.
Read the 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 (n=10), 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 (n=150) examined in the psychiatric division and emergency room (ER) of Sheba. Or patient that recruited from the media.
- Control group (n=50) 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.
- Conditions
- Mental Health Diagnosis
- Being tested
- SP patients-actors, Patients, Control group- patients
- Keywords
- Artificial intelligence, Mental health diagnosis, Medical technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP patients-actorsDiagnostic test
SP Actors employed by MesserMSR, the Israeli Center for Medical Simulation, trained to simulate symptoms of psychiatric illnesses.
PatientsDiagnostic 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.
Control group- patientsDiagnostic test
Control group (n=50) Patients who came to the ER at the hospital due to physical complaints, and no psychiatric history.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Control group- patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 5 month
Secondary outcomes (2)
Percent agreement of the recommendations provided by the AI and the psychiatrists- SPs (actors) part
- For biological treatment divided into groups: anti-depressive medication, Electroconvulsive therapy [ECT]/ketamine, anti-psychotics, mood stabilizers and anxiolytics.
- Psychological treatments: Cognitive behavioral therapy [CBT], dynamic and supportive psychotherapy.
The accuracy of the recommended course of treatment given by the AI and by the psychiatrist will be compared to the gold standard as defined by the training that the SPs received.
Measured: 3 month
Percent agreement of the recommendations provided by the AI and by the psychiatrists - Patients part
- For biological treatment divided into groups: anti-depressive medication, ECT/ketamine, anti-psychotics, mood stabilizers and anxiolytics.
- Psychological treatments: CBT, dynamic and supportive psychotherapy. The psychiatrist will be considered as the gold standard, and the AI recommendations of treatment will be compared to those given by the psychiatrist.
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start12 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DiagnosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mark Weiser, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417827
- Sponsor's protocol ID
- SHEBA-23-0356-MW-CTIL
- Status last verified
- Nov 2023
- First submitted
- 10 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence for Mental Health Diagnoses and Treatment Plans: A Protocol for Actors and Patients
- ClinicalTrials.gov ID
- NCT06417827
- Acronym / sponsor ID
- SHEBA-23-0356-MW-CTIL
- Conditions
- Mental Health Diagnosis
- Keywords
- Artificial intelligence, Mental health diagnosis, Medical technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (n=10), 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 (n=150) examined in the psychiatric division and emergency room (ER) of Sheba. Or patient that recruited from the media.
- Control group (n=50) 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SP patients-actors | Experimental | Diagnostic Test: SP patients-actorsThe 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. |
| Patients | Experimental | Diagnostic Test: PatientsThe 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. |
| Control group- patients | Other | Diagnostic Test: Control group- patientsControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (2 listed)
- Patients participating in another study
- Patients under hospitalization order or court order
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP patients-actorsSP Actors employed by MesserMSR, the Israeli Center for Medical Simulation, trained to simulate symptoms of psychiatric illnesses. | Diagnostic test | SP patients-actors |
| PatientsPatients (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. | Diagnostic test | Patients |
| Control group- patientsControl group (n=50) Patients who came to the ER at the hospital due to physical complaints, and no psychiatric history. | Diagnostic test | Control group- patients |
Primary outcome
Percent agreement of the diagnosis that provide by the psychiatrist and the AI - SPs (actors) part
Time frame: 3 month
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
Percent agreement of the diagnosis that provide by the psychiatrist and the AI- Patients part
Time frame: 5 month
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.
2 secondary outcomes
Percent agreement of the recommendations provided by the AI and the psychiatrists- SPs (actors) part
Time frame: 3 month
Percent agreement of the recommendations provided by the AI and by the psychiatrists - Patients part
Time frame: 5 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Weiser, M.D principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SP patients-actors and Patients in people with Mental Health Diagnosis, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Weiser, M.D (+972526666570, Mark.Weiser@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent agreement of the diagnosis that provide by the psychiatrist and the AI - SPs (actors) part (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.