Mental Illness StigmaAI-SIM-PSYNCT07896538
AI Simulation to Reduce Stigma and Enhance Psychiatric Readiness in Nursing Students
A study testing AI-Simulation Programme and Standard Psychiatric-Mental Health Nursing Curriculum in people with Mental Illness Stigma and Psychiatric Nursing, run by Alexandria University at 1 site in Egypt.
Trial summary
Mental illness stigma among nursing students can undermine the quality of care that people with psychiatric conditions receive, and many students feel unprepared for psychiatric practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Illness Stigma, Psychiatric Nursing
- What is being tested?
- AI-Simulation Programme and Standard Psychiatric-Mental Health Nursing Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Officially enrolled as a fourth-year undergraduate nursing student at the Faculty of Nursing, Alexandria University, and registered in the second clinical rotation group of the psychiatric-mental health nursing course for the 2026/2027 academic year.
- Willing and able to provide written informed consent.
- Access to a smartphone, tablet, or computer with internet connectivity sufficient to complete the simulation sessions and online questionnaires.
Who cannot join
- Repeating the psychiatric-mental health nursing course.
- Previous participation in this or a similar AI-based or virtual psychiatric simulation programme.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Nursing, Alexandria University
Alexandria, Alexandria Governorate, 21511
Mohamed Fakhry Ahmed Salem, PhD Medical-Surgical Nursing, 01286038014, Mohamed.Fakhry@alexu.edu.eg
Mohamed Fakhry Ahmed Salem, PhD in Medical-Surgical Nursin
About this study
Official title: Reducing Mental Health Stigma and Enhancing Readiness for Psychiatric Practice Via AI Simulation Among Nursing Students: The Mediating Role of Psychological Safety. A Randomized Controlled Trial
Mental illness stigma among nursing students can undermine the quality of care that people with psychiatric conditions receive, and many students feel unprepared for psychiatric practice. This randomized controlled trial will examine whether an AI-based psychiatric simulation programme can reduce stigma and improve readiness for psychiatric nursing practice among fourth-year nursing students at the Faculty of Nursing, Alexandria University, Egypt. It will also test whether these effects are explained by students' sense of psychological safety during simulation-based learning.
Two hundred students will be randomly allocated 1:1 to either the intervention or the control arm. Both arms will receive the standard psychiatric-mental health nursing curriculum. The intervention arm will additionally complete five individual AI-simulation cases (one per week over five weeks, about 15-20 minutes each), covering depression with suicide risk, mania, schizophrenia, substance use disorder, and borderline personality disorder with self-harm. Each case includes a structured interview with a simulated patient, a standardized stigma-trigger statement, automated feedback, and an opportunity to retry.
Mental illness stigma, readiness for psychiatric practice, and psychological safety will be measured online at two time points: baseline and immediately after the fifth case. Intervention-arm students will also answer two open-ended questions, analyzed thematically to help explain the quantitative findings.
- Conditions
- Mental Illness Stigma, Psychiatric Nursing
- Being tested
- AI-Simulation Programme, Standard Psychiatric-Mental Health Nursing Curriculum
- Keywords
- Mental illness stigma, Psychological safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Simulation ProgrammeBehavioural
Five individual AI-simulation cases on a dedicated psychiatric simulation platform, one case per week over five consecutive weeks, each lasting about 15-20 minutes and delivered as a low-stakes, ungraded learning activity after a brief orientation. Cases are delivered in a fixed order from least to most emotionally demanding: major depression with suicide risk, mania/bipolar disorder, schizophrenia with hallucinations, substance use disorder with withdrawal, and borderline personality disorder with self-harm. Each case includes a timed structured interview with a simulated patient in Egyptian colloquial Arabic, a Mental State Examination checklist, a standardized (fixed) stigma-trigger statement, a first-attempt response, automated AI feedback, a retry opportunity, and a performance summary. The platform retains no conversational content.
Standard Psychiatric-Mental Health Nursing CurriculumOther
The Faculty's usual psychiatric-mental health nursing course for fourth-year students, comprising theoretical instruction, a supervised clinical rotation, and the usual role-play, video-based, and case-study simulation activities, preceded by the Faculty's standard pre-clinical orientation package (a "Myth-or-Fact" stigma-awareness activity and a self-awareness journaling exercise). Delivered to both study arms without modification.
| Study group | Role | What they receive |
|---|---|---|
| AI-Simulation + Standard Curriculum | Experimental | Participants receive the standard psychiatric-mental health nursing curriculum plus five individual AI-simulation cases (one per week for five weeks) in addition to usual course activities. Receives: Behavioral: AI-Simulation Programme |
| Standard Curriculum Alone | Other | Participants receive the standard psychiatric-mental health nursing curriculum only, including the usual role-play, video-based, and case-study simulation activities, with no AI-simulation cases. Receives: Other: Standard Psychiatric-Mental Health Nursing Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental illness stigma: Opening Minds Stigma Scale for Health Care Providers (OMS-HC) total score
Stigma towards people with mental illness measured with the Opening Minds Stigma Scale for Health Care Providers (OMS-HC), a 15-item self-report questionnaire with three subscales (attitudes, disclosure and help-seeking, social distance). Items are rated from strongly agree to strongly disagree, with selected items reverse-scored. Minimum total score 15, maximum 75. Higher scores indicate more stigmatizing attitudes (worse outcome). Unit of measure: score on a scale.
Measured: Baseline (one week before the first case) and immediately after the fifth simulation case (week 5)
Readiness for psychiatric practice: adapted 21-item Preparedness instrument (Dela Rosa and Maniago, 2018) total score
Readiness for psychiatric nursing practice measured with the adapted 21-item Preparedness instrument (Dela Rosa and Maniago, 2018), a self-report questionnaire covering knowledge, skills, and attitude (7 items each). Items are rated from 1 (not prepared) to 4 (very much prepared). Minimum total score 21, maximum 84. Higher scores indicate greater readiness (better outcome). Unit of measure: score on a scale.
Measured: Baseline (one week before the first case) and immediately after the fifth simulation case (week 5)
Secondary outcomes (1)
Psychological safety: Psychological Safety in High Fidelity Simulation scale (Park and Kim, 2021) total score
Psychological safety measured with the 14-item Psychological Safety in High Fidelity Simulation scale (Park and Kim, 2021), a self-report questionnaire with four factors (dealing with uncertainty, being exposed, being unsupported, interpersonal risk). Items are rated from 1 (strongly disagree) to 5 (strongly agree). Minimum total score 14, maximum 70. Higher scores indicate greater psychological safety (better outcome). Unit of measure: score on a scale.
Measured: Baseline (one week before the first case) and immediately after the fifth simulation case (week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Illness StigmaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fakhry Ahmed Salem, University of Alexandria
- Investigators
- Mohamed Salem, PHD, Principal investigator, Alexandria UniversityMohamed Salem, Principal investigator, Alexandria UniversityMohamed F Ahmed Salem, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896538
- Sponsor's protocol ID
- AU-20-10-496
- Acronym
- AI-SIM-PSY
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Mental Health Stigma and Enhancing Readiness for Psychiatric Practice Via AI Simulation Among Nursing Students: The Mediating Role of Psychological Safety. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07896538
- Acronym / sponsor ID
- AI-SIM-PSY / AU-20-10-496
- Conditions
- Mental Illness Stigma, Psychiatric Nursing
- Keywords
- Mental illness stigma, Psychological safety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Oct 2026 (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.
Mental illness stigma among nursing students can undermine the quality of care that people with psychiatric conditions receive, and many students feel unprepared for psychiatric practice. This randomized controlled trial will examine whether an AI-based psychiatric simulation programme can reduce stigma and improve readiness for psychiatric nursing practice among fourth-year nursing students at the Faculty of Nursing, Alexandria University, Egypt. It will also test whether these effects are explained by students' sense of psychological safety during simulation-based learning.
Two hundred students will be randomly allocated 1:1 to either the intervention or the control arm. Both arms will receive the standard psychiatric-mental health nursing curriculum. The intervention arm will additionally complete five individual AI-simulation cases (one per week over five weeks, about 15-20 minutes each), covering depression with suicide risk, mania, schizophrenia, substance use disorder, and borderline personality disorder with self-harm. Each case includes a structured interview with a simulated patient, a standardized stigma-trigger statement, automated feedback, and an opportunity to retry.
Mental illness stigma, readiness for psychiatric practice, and psychological safety will be measured online at two time points: baseline and immediately after the fifth case. Intervention-arm students will also answer two open-ended questions, analyzed thematically to help explain the quantitative findings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Simulation + Standard Curriculum | Experimental | Behavioral: AI-Simulation ProgrammeParticipants receive the standard psychiatric-mental health nursing curriculum plus five individual AI-simulation cases (one per week for five weeks) in addition to usual course activities. |
| Standard Curriculum Alone | Other | Other: Standard Psychiatric-Mental Health Nursing CurriculumParticipants receive the standard psychiatric-mental health nursing curriculum only, including the usual role-play, video-based, and case-study simulation activities, with no AI-simulation cases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Officially enrolled as a fourth-year undergraduate nursing student at the Faculty of Nursing, Alexandria University, and registered in the second clinical rotation group of the psychiatric-mental health nursing course for the 2026/2027 academic year.
- Willing and able to provide written informed consent.
- Access to a smartphone, tablet, or computer with internet connectivity sufficient to complete the simulation sessions and online questionnaires.
Key exclusion criteria (2 listed)
- Repeating the psychiatric-mental health nursing course.
- Previous participation in this or a similar AI-based or virtual psychiatric simulation programme.
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 |
|---|---|---|
| AI-Simulation ProgrammeFive individual AI-simulation cases on a dedicated psychiatric simulation platform, one case per week over five consecutive weeks, each lasting about 15-20 minutes and delivered as a low-stakes, ungraded learning activity after a brief orientation. Cases are delivered in a fixed order from least to most emotionally demanding: major depression with suicide risk, mania/bipolar disorder, schizophrenia with hallucinations, substance use disorder with withdrawal, and borderline personality disorder with self-harm. Each case includes a timed structured interview with a simulated patient in Egyptian colloquial Arabic, a Mental State Examination checklist, a standardized (fixed) stigma-trigger statement, a first-attempt response, automated AI feedback, a retry opportunity, and a performance summary. The platform retains no conversational content. | Behavioural | AI-Simulation + Standard Curriculum |
| Standard Psychiatric-Mental Health Nursing CurriculumThe Faculty's usual psychiatric-mental health nursing course for fourth-year students, comprising theoretical instruction, a supervised clinical rotation, and the usual role-play, video-based, and case-study simulation activities, preceded by the Faculty's standard pre-clinical orientation package (a "Myth-or-Fact" stigma-awareness activity and a self-awareness journaling exercise). Delivered to both study arms without modification. | Other | Standard Curriculum Alone |
Primary outcome
Mental illness stigma: Opening Minds Stigma Scale for Health Care Providers (OMS-HC) total score
Time frame: Baseline (one week before the first case) and immediately after the fifth simulation case (week 5)
Stigma towards people with mental illness measured with the Opening Minds Stigma Scale for Health Care Providers (OMS-HC), a 15-item self-report questionnaire with three subscales (attitudes, disclosure and help-seeking, social distance). Items are rated from strongly agree to strongly disagree, with selected items reverse-scored. Minimum total score 15, maximum 75. Higher scores indicate more stigmatizing attitudes (worse outcome). Unit of measure: score on a scale.
Readiness for psychiatric practice: adapted 21-item Preparedness instrument (Dela Rosa and Maniago, 2018) total score
Time frame: Baseline (one week before the first case) and immediately after the fifth simulation case (week 5)
Readiness for psychiatric nursing practice measured with the adapted 21-item Preparedness instrument (Dela Rosa and Maniago, 2018), a self-report questionnaire covering knowledge, skills, and attitude (7 items each). Items are rated from 1 (not prepared) to 4 (very much prepared). Minimum total score 21, maximum 84. Higher scores indicate greater readiness (better outcome). Unit of measure: score on a scale.
1 secondary outcome
Psychological safety: Psychological Safety in High Fidelity Simulation scale (Park and Kim, 2021) total score
Time frame: Baseline (one week before the first case) and immediately after the fifth simulation case (week 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Mohamed Salem, PHD principal investigator
Alexandria University
Mohamed Salem principal investigator
Alexandria University
Mohamed F Ahmed Salem principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Simulation Programme and Standard Psychiatric-Mental Health Nursing Curriculum in people with Mental Illness Stigma and Psychiatric Nursing, run by Alexandria University at 1 site in Egypt.
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 3 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Fakhry Salem, PhD (01286038014, Mohamed.Fakhry@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental illness stigma: Opening Minds Stigma Scale for Health Care Providers (OMS-HC) total score (time frame: Baseline (one week before the first case) and immediately after the fifth simulation case (week 5)). 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 27 Oct 2026.