Integrated Mental Health Nursing Program: Effects on Stigma, Cognitive Flexibility, and Clinical Readiness (IMHNEP)

May 21, 2026 updated by: Heba Mohamed Abdelaal, Alexandria University

Effect of an Integrated Mental Health Nursing Educational Program on Stigma, Cognitive Flexibility, and Clinical Readiness Among Nursing Students: A Quasi-Experimental Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mental health nursing education plays a critical role in preparing nursing students to provide competent, compassionate, and evidence-based care for individuals with mental health disorders. However, stigma toward mental illness, limited cognitive flexibility, and inadequate clinical readiness remain important challenges among undergraduate nursing students. These challenges may negatively influence students' attitudes toward mental health care, reduce confidence in psychiatric settings, and affect the quality of care delivered to patients with mental illness.

This study is designed to examine the effect of an Integrated Mental Health Nursing Educational Program (IMHNEP) on three key outcomes among nursing students: stigma, cognitive flexibility, and clinical readiness. The study will use a quasi-experimental one-group pretest-posttest design.

The study will be conducted at the Faculty of Nursing, Damanhour University, Egypt. Participants will include undergraduate nursing students enrolled in the psychiatric nursing course during the second clinical rotation of the 2025-2026 academic year. A convenience sample of 240 students will be recruited. Eligible participants are students enrolled in the psychiatric nursing course who have no prior psychiatric nursing experience or previous clinical exposure to psychiatric patients. Students who have previously studied psychiatric nursing or have prior experience caring for psychiatric patients will be excluded.

The intervention, IMHNEP, is a structured educational and clinical training program delivered over 6 consecutive weeks from April to May 2026. The program includes lectures, interactive discussions, reflective learning activities, case-based learning, and supervised clinical training experiences. The educational content focuses on mental health awareness, stigma reduction, cognitive restructuring approaches, and essential psychiatric nursing competencies. The program is intended to improve students' attitudes toward mental illness, promote flexible thinking and adaptive reasoning, and increase confidence and readiness for clinical psychiatric nursing practice.

Data will be collected at two time points: pre-intervention assessment during the first week of the program and post-intervention assessment during the final week of the program. The primary study outcomes will be measured using validated instruments. Stigma will be assessed using the Opening Minds Stigma Scale for Health Care Providers (OMS-HC-15). Cognitive flexibility will be assessed using the Cognitive Flexibility Inventory (CFI). Clinical readiness will be assessed using the Mental Health Nursing Clinical Confidence Scale (MHNCCS).

Participation in the study will be voluntary. Informed consent will be obtained from all participants before data collection. Confidentiality and anonymity will be maintained throughout the study, and participants will have the right to withdraw from the study at any time without penalty.

This study may provide evidence on the effectiveness of an integrated mental health nursing educational intervention in reducing stigma and improving adaptive thinking and clinical preparedness among nursing students. The findings may contribute to improving undergraduate psychiatric nursing education and supporting better preparation of future nurses for mental health care settings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Damanhour
      • Beheira, Damanhour, Egypt, 02
        • Faculty of Nursing, Damanhour University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Integrated Mental Health Nursing Educational Program Group
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stigma toward Mental Illness
Time Frame: Baseline and immediately after the 6-week intervention
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
Time Frame: Baseline and immediately after the 6-week intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Readiness for Mental Health Nursing Practice
Time Frame: Baseline and immediately after the 6-week intervention
Measured using the Mental Health Nursing Clinical Confidence Scale (MHNCCS). The scale includes 20 items rated from 1 (not at all confident) to 4 (completely confident), yielding a total score range of 20 to 80; higher scores indicate greater clinical confidence and readiness for mental health nursing practice.
Baseline and immediately after the 6-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heba Mohamed Abdelaal, Doctorate, Alexandria University, Faculty of Nursing
  • Study Chair: Walaa Elsayed Mohamed Elsayed Khalil, Doctorate, Faculty of Nursing, Alexandria University
  • Study Chair: Laila Saad Mahmoud Shoukhba, Doctorate, Faculty of Nursing, Alexandria University
  • Study Director: Omima Mohamed Ibrahim Morsy, Doctorate, Faculty of Nursing, Damanhour University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 21, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 21, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Damn.Nur.REC#122-d; 9 March 20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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