NCT07848022

Brief Summary

This quasi-experimental study aims to evaluate the effectiveness of a nurse-facilitated artificial intelligence (AI) chatbot in improving psychological well-being and reducing mental health stigma among patients with psychiatric disorders. Participants will receive support through an AI chatbot supervised by trained psychiatric nurses. The chatbot will provide mental health education, emotional support, coping strategies, and guidance for self-management. Outcomes will include changes in psychological well-being and levels of mental health stigma before and after the intervention. The findings may help determine whether AI-assisted nursing interventions can enhance mental health care and support recovery among individuals with psychiatric disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

July 31, 2026

Last Update Submit

September 25, 2026

Conditions

Keywords

Artificial Intelligence Chatbot AI Mental Health Intervention Nurse-Facilitated Intervention Psychological Well-Being Mental Health Stigma

Outcome Measures

Primary Outcomes (1)

  • Psychological Well-being

    Change in psychological well-being scores among patients with psychiatric disorders following participation in the nurse-facilitated artificial intelligence chatbot intervention.

    Baseline (pre-intervention) and 2 weeks post-intervention Baseline (pre-intervention) and 4 weeks post-intervention Baseline (pre-intervention) and 3 months post-intervention

Study Arms (2)

Usual Care Control Group

NO INTERVENTION

Participants receive the standard psychiatric care routinely provided by the healthcare facility, including regular psychiatric consultations, prescribed treatment, and follow-up services. Participants in this arm do not receive access to the nurse-facilitated artificial intelligence chatbot during the study period. Outcome measures are assessed at the same time points as the intervention group for comparison purposes.

Nurse-Facilitated AI Chatbot Intervention

EXPERIMENTAL

Participants receive the standard psychiatric care routinely provided by the healthcare facility, including regular psychiatric consultations, prescribed treatment, and follow-up services. Participants in this arm do not receive access to the nurse-facilitated artificial intelligence chatbot during the study period. Outcome measures are assessed at the same time points as the intervention group for comparison purposes.

Behavioral: Nurse-Facilitated Artificial Intelligence Chatbot

Interventions

A nurse-facilitated artificial intelligence chatbot designed to provide psychoeducational information, emotional support, coping strategies, and mental health guidance for patients with psychiatric disorders. The chatbot is supervised by psychiatric nurses and aims to improve psychological well-being and reduce mental health stigma.

Nurse-Facilitated AI Chatbot Intervention

Eligibility Criteria

Age18 Months - 65 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Able to read and communicate in Arabic. Possess a smartphone or device with internet access to use the AI chatbot. Willing to participate and provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eman Shokr

Amman, Jordan

Location

Related Publications (1)

  • 16. Ryff C. D. (2014). Psychological well-being revisited: advances in the science and practice of eudaimonia. Psychotherapy and psychosomatics, 83(1), 10-28. https://doi.org/10.1159/000353263. 17. Yasuhara, K., Formon, D. L., Phillips, S. & Yenne, E. M. Mental health stigma scale [Database record]. APA PsycTests (2019). https://doi.org/10.1037/t76798-000 18. Andersen, S. M., Randers, A., Jensen, C. M., Bisgaard, C., & Steinhausen, H. C. (2013). Preceding diagnoses to young adult bipolar disorder and schizophrenia in a nationwide study. BMC psychiatry, 13, 343. https://doi.org/10.1186/1471-244X-13-343 19. McKenzie, S. K., Oliffe, J. L., Black, A., & Collings, S. (2022). Men's Experiences of Mental Illness Stigma Across the Lifespan: A Scoping Review. American journal of men's health, 16(1), 15579883221074789. https://doi.org/10.1177/15579883221074789 20. Kirkbride, J. B., Anglin, D. M., Colman, I., Dykxhoorn, J., Jones, P. B., Patalay, P., Pitman, A., Soneson, E., Steare, T., Wright, T., & Griffiths, S. L. (2024). The social determinants of mental health and disorder: evidence, prevention and recommendations. World psychiatry: official journal of the World Psychiatric Association (WPA), 23(1), 58-90. https://doi.org/10.1002/wps.21160 21. Waqas, A., Malik, S., Fida, A., Abbas, N., Mian, N., Miryala, S., Amray, A. N., Shah, Z., & Naveed, S. (2020). Interventions to Reduce Stigma Related to Mental Illnesses in Educational Institutes: a Systematic Review. The Psychiatric quarterly, 91(3), 887-903. https://doi.org/10.1007/s11126-020-09751-4

    RESULT

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study is open-label; both participants and investigators are aware of the intervention assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a quasi-experimental, nonrandomized study evaluating the effect of a nurse-facilitated AI chatbot intervention on psychological well-being and mental health stigma among patients with psychiatric disorders.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 31, 2026

First Posted

September 29, 2026

Study Start

January 11, 2023

Primary Completion

April 11, 2023

Study Completion

May 12, 2024

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
De-identified individual participant data (IPD) and supporting study documents will be made available beginning 6 months after publication of the primary study results and will remain available for up to 5 years.

Locations