Mental Health StigmaIMHNEPNCT07517861
Integrated Mental Health Nursing Program: Effects on Stigma, Cognitive Flexibility, and Clinical Readiness
A study testing Integrated Mental Health Nursing Educational Program (IMHNEP) in people with Mental Health Stigma and Cognitive Flexibility, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Stigma, Cognitive Flexibility, Clinical Readiness
- What is being tested?
- Integrated Mental Health Nursing Educational Program (IMHNEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Apr 2026to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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. The second clinical-rotation cohort comprised 240 students, all of whom were screened against the registered eligibility criteria. Ninety-six students were ineligible because they had previously completed Psychiatric and Mental Health Nursing; some also had prior psychiatric clinical/work experience. The remaining 144 eligible students provided informed consent and were enrolled in the research study at baseline. Four participants did not complete the post-intervention assessment, leaving 140 participants with complete paired pre-post data.
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.
- Conditions
- Mental Health Stigma, Cognitive Flexibility, Clinical Readiness, Mental Health Nursing Education
- Being tested
- Integrated Mental Health Nursing Educational Program (IMHNEP)
- Keywords
- Mental Health Nursing, Nursing Students, Stigma Reduction, Cognitive Flexibility, Clinical Competence, Psychiatric Nursing, Educational Intervention, Quasi-Experimental Study, Nursing Education, Mental Health Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Mental Health Nursing Educational Program (IMHNEP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Integrated Mental Health Nursing Educational Program (IMHNEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and immediately after the 6-week intervention
Secondary outcomes (1)
Clinical Readiness for Mental Health Nursing Practice
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.
Measured: Baseline and immediately after the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start7 Apr 2026
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health StigmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One-group pretest-posttest quasi-experimental design. All participants receive the same educational intervention, with assessments conducted before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohamed Abdelaal, Alexandria University
- Investigators
- Heba Mohamed Abdelaal, Doctorate, Principal investigator, Alexandria University, Faculty of NursingWalaa Elsayed Mohamed Elsayed Khalil, Doctorate, Study chair, Faculty of Nursing, Alexandria UniversityLaila Saad Mahmoud Shoukhba, Doctorate, Study chair, Faculty of Nursing, Alexandria UniversityOmima Mohamed Ibrahim Morsy, Doctorate, Study director, Faculty of Nursing, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517861
- Sponsor's protocol ID
- Damn.Nur.REC#122-d; 9 March 26
- Acronym
- IMHNEP
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 24758158Inan 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.
PubMed 31126397
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Integrated Mental Health Nursing Educational Program on Stigma, Cognitive Flexibility, and Clinical Readiness Among Nursing Students: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07517861
- Acronym / sponsor ID
- IMHNEP / Damn.Nur.REC#122-d; 9 March 26
- Conditions
- Mental Health Stigma, Cognitive Flexibility, Clinical Readiness, Mental Health Nursing Education
- Keywords
- Mental Health Nursing, Nursing Students, Stigma Reduction, Cognitive Flexibility, Clinical Competence, Psychiatric Nursing, Educational Intervention, Quasi-Experimental Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. The second clinical-rotation cohort comprised 240 students, all of whom were screened against the registered eligibility criteria. Ninety-six students were ineligible because they had previously completed Psychiatric and Mental Health Nursing; some also had prior psychiatric clinical/work experience. The remaining 144 eligible students provided informed consent and were enrolled in the research study at baseline. Four participants did not complete the post-intervention assessment, leaving 140 participants with complete paired pre-post data.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One-group pretest-posttest quasi-experimental design. All participants receive the same educational intervention, with assessments conducted before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Integrated Mental Health Nursing Educational Program Group | Experimental | Behavioral: Integrated Mental Health Nursing Educational Program (IMHNEP)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. |
Who may qualify
- Ages
- 20 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Integrated Mental Health Nursing Educational Program Group |
Primary outcome
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.
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.
1 secondary outcome
Clinical Readiness for Mental Health Nursing Practice
Time frame: Baseline and immediately after the 6-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 24758158Modgill 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.
- Background: PubMed 31126397Inan 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba Mohamed Abdelaal, Doctorate principal investigator
Alexandria University, Faculty of Nursing
Walaa Elsayed Mohamed Elsayed Khalil, Doctorate study chair
Faculty of Nursing, Alexandria University
Laila Saad Mahmoud Shoukhba, Doctorate study chair
Faculty of Nursing, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Mental Health Nursing Educational Program (IMHNEP) in people with Mental Health Stigma and Cognitive Flexibility, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stigma toward Mental Illness (time frame: Baseline and immediately after the 6-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07517861, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.