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Not yet recruitingNCT07905469AI-CHAT-PSYUpdated Oct 29, 2026

Culturally-Tailored AI Chatbot Simulation for Therapeutic Communication and Empathy in Psychiatric Nursing Students

An interventional study of Culturally-Tailored AI Chatbot Simulation and Instructor-Facilitated Peer Role-Play in Therapeutic Communication, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Alexandria University · Not applicable, Interventional, and Other

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Therapeutic Communication

Keywords

  • AI chatbot simulation
03

In context

Lead sponsor

Alexandria University is the lead sponsor of 596 studies on the registry; 134 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    AI Chatbot Simulation + Standard Curriculum

    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.

    Behavioral: Culturally-Tailored AI Chatbot Simulation

  • Active comparator
    Peer Role-Play + Standard Curriculum

    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.

    Other: Instructor-Facilitated Peer Role-Play

Interventions

  • BehavioralCulturally-Tailored AI Chatbot Simulation

    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.

  • OtherInstructor-Facilitated Peer Role-Play

    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.

06

What researchers measure

Primary outcomes

  1. Kiersma-Chen Empathy Scale-Revised (KCES-R)

    Time frame: Baseline (one week before the intervention) and immediately after the final simulation module (week 4)

  2. 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)

Secondary outcomes

  1. 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

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2026
First posted
Oct 29, 2026
StartEst.
Oct 20, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07905469
Responsible party
Mohamed Fakhry Ahmed Salem (DR, Alexandria University) — Principal investigator
First posted
Oct 29, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 29, 2026

Study contacts

Mohamed Salem, PhD
Contact
Mohamed.Fakhry@alexu.edu.eg
01286038014
Mohamed Salem
principal investigator · Alexandria University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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