NCT07517861

Brief Summary

This quasi-experimental one-group pretest-posttest study aims to evaluate the effect of an Integrated Mental Health Nursing Educational Program on stigma, cognitive flexibility, and clinical readiness among undergraduate nursing students. The study will be conducted at the Faculty of Nursing, Damanhour University, Egypt, among students enrolled in the psychiatric nursing course during the second clinical rotation of the 2025-2026 academic year. The intervention consists of a structured 6-week educational program that includes teaching sessions, interactive discussions, reflective exercises, case-based learning, and guided clinical experiences. The program is designed to improve mental health awareness, reduce stigma toward people with mental illness, enhance cognitive flexibility, and strengthen students' readiness for psychiatric nursing practice. Outcome measures will be assessed before and after the intervention using validated tools: the Opening Minds Stigma Scale for Health Care Providers (OMS-HC-15), the Cognitive Flexibility Inventory (CFI), and the Mental Health Nursing Clinical Confidence Scale (MHNCCS). The findings may support the integration of structured mental health nursing education into undergraduate nursing curricula to improve students' attitudes, thinking skills, and clinical preparedness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 7, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2026

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

April 2, 2026

Last Update Submit

May 21, 2026

Conditions

Mental Health StigmaCognitive FlexibilityClinical ReadinessMental Health Nursing Education

Keywords

Mental Health NursingNursing StudentsStigma ReductionCognitive FlexibilityClinical CompetencePsychiatric NursingEducational InterventionQuasi-Experimental StudyNursing EducationMental Health Awareness

Outcome Measures

Primary Outcomes (2)

  • Stigma toward Mental Illness

    Measured using the Opening Minds Stigma Scale for Health Care Providers, 15-item version (OMS-HC-15). Total scores range from 15 to 75, with higher scores indicating greater stigma toward mental illness.

    Baseline and immediately after the 6-week intervention

  • Cognitive Flexibility

    Measured using the Cognitive Flexibility Inventory (CFI). Total scores range from 20 to 140, with higher scores indicating greater cognitive flexibility.

    Baseline and immediately after the 6-week intervention

Secondary Outcomes (1)

  • Clinical Readiness for Mental Health Nursing Practice

    Baseline and immediately after the 6-week intervention

Study Arms (1)

Integrated Mental Health Nursing Educational Program Group

EXPERIMENTAL

Participants will receive the Integrated Mental Health Nursing Educational Program (IMHNEP), a structured 6-week educational intervention including lectures, interactive discussions, reflective exercises, case-based learning, and supervised clinical training. The program aims to reduce stigma, enhance cognitive flexibility, and improve clinical readiness among nursing students.

Behavioral: Integrated Mental Health Nursing Educational Program (IMHNEP)

Interventions

Integrated Mental Health Nursing Educational Program (IMHNEP)BEHAVIORAL

The intervention is a structured 6-week educational program designed for undergraduate nursing students. It includes lectures, interactive discussions, reflective exercises, case-based learning, and supervised clinical training. The program focuses on mental health awareness, stigma reduction, cognitive restructuring techniques, and essential psychiatric nursing competencies. It aims to improve students' attitudes toward mental illness, enhance cognitive flexibility, and increase clinical readiness for psychiatric nursing practice.

Integrated Mental Health Nursing Educational Program Group

Eligibility Criteria

Age20 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Undergraduate nursing students enrolled in the psychiatric nursing course at the Faculty of Nursing, Damanhour University
  • Students assigned to the second clinical rotation during the second semester of the 2025-2026 academic year
  • Students who have not previously studied psychiatric nursing
  • Students with no prior clinical exposure to psychiatric patients
  • Students who are willing to participate and provide informed consent

You may not qualify if:

  • Students who have previously studied psychiatric nursing
  • Students with prior experience caring for psychiatric patients in hospital or clinical settings
  • Students who refuse to participate
  • Students who do not complete the pre-test or post-test assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Damanhour University

Beheira, Damanhour, 02, Egypt

Location

Related Publications (2)

  • Modgill G, Patten SB, Knaak S, Kassam A, Szeto AC. Opening Minds Stigma Scale for Health Care Providers (OMS-HC): examination of psychometric properties and responsiveness. BMC Psychiatry. 2014 Apr 23;14:120. doi: 10.1186/1471-244X-14-120.

    PMID: 24758158BACKGROUND

  • Inan FS, Gunusen N, Duman ZC, Ertem MY. The Impact of Mental Health Nursing Module, Clinical Practice and an Anti-Stigma Program on Nursing Students' Attitudes toward Mental Illness: A Quasi-Experimental Study. J Prof Nurs. 2019 May-Jun;35(3):201-208. doi: 10.1016/j.profnurs.2018.10.001. Epub 2018 Oct 12.

    PMID: 31126397BACKGROUND

Study Officials

  • Heba Mohamed Abdelaal, Doctorate

    Alexandria University, Faculty of Nursing

    PRINCIPAL INVESTIGATOR

  • Walaa Elsayed Mohamed Elsayed Khalil, Doctorate

    Faculty of Nursing, Alexandria University

    STUDY CHAIR

  • Laila Saad Mahmoud Shoukhba, Doctorate

    Faculty of Nursing, Alexandria University

    STUDY CHAIR

  • Omima Mohamed Ibrahim Morsy, Doctorate

    Faculty of Nursing, Damanhour University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: One-group pretest-posttest quasi-experimental design. All participants receive the same educational intervention, with assessments conducted before and after the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 8, 2026

Study Start

April 7, 2026

Primary Completion

May 21, 2026

Study Completion

May 21, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to ethical and confidentiality considerations. The data include sensitive information collected from undergraduate nursing students, and sharing such data may risk participant privacy. All data will be reported in aggregate form only.

Locations

EG(1)