- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517861
Integrated Mental Health Nursing Program: Effects on Stigma, Cognitive Flexibility, and Clinical Readiness (IMHNEP)
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Damanhour
-
Beheira, Damanhour, Egypt, 02
- Faculty of Nursing, Damanhour University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
Sponsor
Investigators
- 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
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Damn.Nur.REC#122-d; 9 March 20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cognitive Flexibility
-
Sheffield Hallam UniversityCompletedCognitive FlexibilityUnited Kingdom
-
Riphah International UniversityCompletedCognitive Flexibility Among Female TeenagersPakistan
-
NeuroMeditation InstituteCompletedCognitive Flexibility | Positive Mood States | Negative Mood States | Cognitive Processing SpeedUnited States
-
Shanghai University of SportCompletedCognitive Impairment | Cognitive FlexibilityChina
-
University of Wisconsin, MadisonUnited States Department of DefenseCompleted
-
Aydin Adnan Menderes UniversityCompletedAnxiety Disorders | Mindfulness | Perceived Stress | Intolerance of Uncertainty | Cognitive FlexibilityTurkey (Türkiye)
-
Marmara UniversityNot yet recruitingStress, Psychological | Menopause | Randomized Controlled Trial | Yoga | Cortisol | Perceived Stress | Cognitive Control | Cognitive Flexibility | Nonpharmacological Interventions
-
Universidad del Valle, ColombiaCompletedEmotional Distress | Psychological Flexibility | Psychological Well-Being | Experiential Avoidance | Cognitive FusionColombia
-
Sheffield Hallam UniversityUnknownModulation of Cognitive Flexibility by Transcranial Direct Current Stimulation, Tyrosine Administration and Polymorphisms in the COMT GeneUnited Kingdom
-
Istituti Clinici Scientifici Maugeri SpAASST Fatebenefratelli Sacco; Istituto Psicologico Italiano s.r.l.s.RecruitingAnorexia Nervosa | Bulimia Nervosa | ARFID | Executive Functions | Cognitive Flexibility | Implicit Association TestItaly
Clinical Trials on Integrated Mental Health Nursing Educational Program (IMHNEP)
-
Assiut UniversityNot yet recruitingMental Health | Help-Seeking Behavior | Mental Health Literacy | Stigma of Mental Illness | Adolescent Mental Health
-
Institut et Haute Ecole de la Santé la SourceHEIG-VD- Haute Ecole d'Ingénierie et de Gestion du Canton de VaudCompletedPreventative MedicineSwitzerland
-
Swiss Medical Academy MarocNot yet recruitingAnxiety | Depression in Adolescence | Depression in Adults | Mental and Behavioural DisordersSwitzerland
-
The Hong Kong Polytechnic UniversityHospital Authority, Hong KongCompleted
-
Kenyatta National HospitalNational Institute of Mental Health (NIMH)RecruitingDepression, Anxiety | Antenatal Depression | Postnatal DepressionKenya
-
Helwan UniversityCompletedBiomedical Waste Management | Empowering Nursing CompetenceEgypt
-
Helwan UniversityCompletedCancer | Chemotherapy Effect | Quality of Life (QOL)Egypt
-
University Hospital, GhentCompletedStress, Psychological | Depression, Postpartum | Puerperal Disorders | Anxiety | Risk Factors | Anxiety Disorder/Anxiety State | Depression During PregnancyBelgium
-
Human Development Research Foundation, PakistanNational Institute of Mental Health (NIMH); University of Washington; World Health... and other collaboratorsCompletedBehavioral Symptoms | Emotional Disorder | ADHD | Conduct Disorder | Emotional Stress | Depression, Anxiety | Emotional Problem | Behavioral Problem | Emotional TraumaPakistan
-
The Fourth Hospital of ShijiazhuangCompletedProfessional BurnoutChina