Therapeutic CommunicationAI-CHAT-PSYNCT07905469
Culturally-Tailored AI Chatbot Simulation for Therapeutic Communication and Empathy in Psychiatric Nursing Students
A study testing Culturally-Tailored AI Chatbot Simulation and Instructor-Facilitated Peer Role-Play in people with Therapeutic Communication, run by Alexandria University at 1 site in Egypt.
Trial summary
Therapeutic communication and empathy are core competencies in psychiatric nursing, yet students often have limited opportunities to practise them safely with culturally realistic patients and families. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Communication
- What is being tested?
- Culturally-Tailored AI Chatbot Simulation and Instructor-Facilitated Peer Role-Play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2026to 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Officially enrolled in the psychiatric and mental health nursing course (fourth-year undergraduate nursing student, Faculty of Nursing, Alexandria University, first clinical rotation group, first semester 2026/2027) and has not yet started the psychiatric clinical rotation.
- Regular access to a smartphone, tablet, or computer with a reliable internet connection.
- Written informed consent.
Who cannot join
- Formal training in therapeutic communication or motivational interviewing outside the standard curriculum.
- Previous use of an AI-based psychiatric simulation.
- Participation in the pilot study.
- Did not complete the baseline assessment (not randomized).
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
Faculty of Nursing, Alexandria University
Alexandria, Alexandria Governorate, 2500
About this study
Official title: Effectiveness of a Culturally-Tailored AI Chatbot Simulation on Enhancing Therapeutic Communication Competence and Empathy Among Psychiatric Nursing Students: A Randomized Controlled Trial
Therapeutic communication and empathy are core competencies in psychiatric nursing, yet students often have limited opportunities to practise them safely with culturally realistic patients and families. This randomized controlled trial will test whether a culturally tailored, large language model (LLM)-driven AI chatbot simulation improves therapeutic communication competence and empathy among fourth-year nursing students at the Faculty of Nursing, Alexandria University, Egypt.
- Conditions
- Therapeutic Communication
- Being tested
- Culturally-Tailored AI Chatbot Simulation, Instructor-Facilitated Peer Role-Play
- Keywords
- AI chatbot simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally-Tailored AI Chatbot SimulationBehavioural
Four weekly individual modules on a secure web-based platform: a 20-minute orientation and three 15-20-minute cases (major depressive disorder, schizophrenia spectrum disorder, bipolar I disorder, manic episode). Students hold free-text conversations with an LLM-driven simulated patient and family member in culturally embedded scenarios (Egyptian colloquial Arabic, idioms of distress, religious explanatory models, family reputation and stigma, medication cost) with bracketed non-verbal cues. Platform features include a Perspective-Taking Drill ("If I were the patient right now, I would feel...") and automated feedback with separate communication and empathy scores. Students follow the Student Clinical Handout, which includes a safety and crisis escalation protocol. Modules are ungraded and an instructor is available in every session.
Instructor-Facilitated Peer Role-PlayOther
Instructor-facilitated role-play in pairs of the same orientation and three cases, matched to the intervention arm in number, order, and length of sessions, using the same Student Clinical Handout. Partners alternate nurse and patient roles using script cards with the same case, cultural content, and cue descriptions; an additional student plays the family member. No AI-embedded Perspective-Taking Drill or automated feedback is provided.
| Study group | Role | What they receive |
|---|---|---|
| AI Chatbot Simulation + Standard Curriculum | Experimental | Participants continue the standard psychiatric nursing curriculum and additionally complete the orientation and three AI-simulated cases individually on the platform, one module per week. Receives: Behavioral: Culturally-Tailored AI Chatbot Simulation |
| Peer Role-Play + Standard Curriculum | Active comparator | Participants continue the standard psychiatric nursing curriculum and additionally complete instructor-facilitated peer role-play of the same orientation and three cases, matched in number, order, and length to the intervention arm. Receives: Other: Instructor-Facilitated Peer Role-Play |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kiersma-Chen Empathy Scale-Revised (KCES-R)
Measured: Baseline (one week before the intervention) and immediately after the final simulation module (week 4)
Observer-rated therapeutic communication competence (behavioral checklist total score)
Measured: Baseline (one week before the intervention) and immediately after the final simulation module (week 4)
Secondary outcomes (1)
Retention of empathy ability: KCES-R Personal Empathy Ability score at four-week follow-up
Measured: Baseline, immediately after the final module (week 4), and four weeks after the final module
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic CommunicationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fakhry Ahmed Salem, Alexandria University
- Investigators
- Mohamed Salem, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905469
- Sponsor's protocol ID
- AU-20-10-501
- Acronym
- AI-CHAT-PSY
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 29 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Culturally-Tailored AI Chatbot Simulation on Enhancing Therapeutic Communication Competence and Empathy Among Psychiatric Nursing Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07905469
- Acronym / sponsor ID
- AI-CHAT-PSY / AU-20-10-501
- Conditions
- Therapeutic Communication
- Keywords
- AI chatbot simulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 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.
Therapeutic communication and empathy are core competencies in psychiatric nursing, yet students often have limited opportunities to practise them safely with culturally realistic patients and families. This randomized controlled trial will test whether a culturally tailored, large language model (LLM)-driven AI chatbot simulation improves therapeutic communication competence and empathy among fourth-year nursing students at the Faculty of Nursing, Alexandria University, Egypt.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI Chatbot Simulation + Standard Curriculum | Experimental | Behavioral: Culturally-Tailored AI Chatbot SimulationParticipants continue the standard psychiatric nursing curriculum and additionally complete the orientation and three AI-simulated cases individually on the platform, one module per week. |
| Peer Role-Play + Standard Curriculum | Active comparator | Other: Instructor-Facilitated Peer Role-PlayParticipants continue the standard psychiatric nursing curriculum and additionally complete instructor-facilitated peer role-play of the same orientation and three cases, matched in number, order, and length to the intervention arm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Officially enrolled in the psychiatric and mental health nursing course (fourth-year undergraduate nursing student, Faculty of Nursing, Alexandria University, first clinical rotation group, first semester 2026/2027) and has not yet started the psychiatric clinical rotation.
- Regular access to a smartphone, tablet, or computer with a reliable internet connection.
- Written informed consent.
Key exclusion criteria (4 listed)
- Formal training in therapeutic communication or motivational interviewing outside the standard curriculum.
- Previous use of an AI-based psychiatric simulation.
- Participation in the pilot study.
- Did not complete the baseline assessment (not randomized).
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 |
|---|---|---|
| Culturally-Tailored AI Chatbot SimulationFour weekly individual modules on a secure web-based platform: a 20-minute orientation and three 15-20-minute cases (major depressive disorder, schizophrenia spectrum disorder, bipolar I disorder, manic episode). Students hold free-text conversations with an LLM-driven simulated patient and family member in culturally embedded scenarios (Egyptian colloquial Arabic, idioms of distress, religious explanatory models, family reputation and stigma, medication cost) with bracketed non-verbal cues. Platform features include a Perspective-Taking Drill ("If I were the patient right now, I would feel...") and automated feedback with separate communication and empathy scores. Students follow the Student Clinical Handout, which includes a safety and crisis escalation protocol. Modules are ungraded and an instructor is available in every session. | Behavioural | AI Chatbot Simulation + Standard Curriculum |
| Instructor-Facilitated Peer Role-PlayInstructor-facilitated role-play in pairs of the same orientation and three cases, matched to the intervention arm in number, order, and length of sessions, using the same Student Clinical Handout. Partners alternate nurse and patient roles using script cards with the same case, cultural content, and cue descriptions; an additional student plays the family member. No AI-embedded Perspective-Taking Drill or automated feedback is provided. | Other | Peer Role-Play + Standard Curriculum |
Primary outcome
Kiersma-Chen Empathy Scale-Revised (KCES-R)
Time frame: Baseline (one week before the intervention) and immediately after the final simulation module (week 4)
Observer-rated therapeutic communication competence (behavioral checklist total score)
Time frame: Baseline (one week before the intervention) and immediately after the final simulation module (week 4)
1 secondary outcome
Retention of empathy ability: KCES-R Personal Empathy Ability score at four-week follow-up
Time frame: Baseline, immediately after the final module (week 4), and four weeks after the final module
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 29 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 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 Culturally-Tailored AI Chatbot Simulation and Instructor-Facilitated Peer Role-Play in people with Therapeutic Communication, 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 4 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: opening soon, as of the sponsor's last update on 29 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 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?
Kiersma-Chen Empathy Scale-Revised (KCES-R) (time frame: Baseline (one week before the intervention) and immediately after the final simulation module (week 4)). 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 29 Oct 2026.