StigmatizationNCT05596305
Outcomes of Anti Stigma Educational Intervention of Ungraduated Medical Students
A study testing educational psychiatry intervention in people with Stigmatization and Medical Education, run by Suez Canal University at 1 site in Egypt.
Trial summary
Background: Stigma causes a significant burden for mental ill patients. Unfortunately, negative attitudes towards mentally ill are not confined to the lay public but are also common among health professionals. Read more about this study
- Who is it for?
- Ages 19 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Stigmatization, Medical Education
- What is being tested?
- educational psychiatry intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Nov 2019to 17 May 2020
- 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 19 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All fourth-year medical students in the faculty of medicine, Suez Canal University.
Who cannot join
- Refusal to participate and/or decline to complete the study for any cause.
- Any Identified history or treatment for psychiatric conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Anti Stigma Educational Intervention of Undergraduate Medical Students Towards Mentally Ill Patients-Suez Canal University Hospital
Background: Stigma causes a significant burden for mental ill patients. Unfortunately, negative attitudes towards mentally ill are not confined to the lay public but are also common among health professionals.
Aim: To study outcomes of psychiatric anti stigma educational intervention on undergraduate medical students' knowledge, attitude, and behavior as primary outcome measures.
Subjects and methods: a quasi-experimental study was conducted on fourth year (120) undergraduate medical students affiliated to faculty of Medicine-Suez Canal University. The participants conducted a semi-structured questionnaire to assess effect of anti-stigma program on their knowledge, attitude and intended behavior toward mentally ill. The participants completed baseline questionnaire, then immediately and after 6 months reassessment. Data was collected from November 2019 to May 2020.
Read the detailed description
Subjects and Methods:
The current study was a quasi-experimental (pre-post) intervention study was conducted on 120 all fourth-year undergraduate medical students affiliated to faculty of medicine, Suez Canal University in Ismailia city, Egypt to assess the outcomes of psychiatric anti-stigma educational intervention on their knowledge, attitude and intended behavior toward mentally ill. Permissions for the study were obtained from the authorities concerned, and the participants medical students were informed about the purpose of the study and signed an informed consent before the beginning of this study.
Methods:
The First part: Consists of socio-demographic data of each medical student, which includes age, gender, family history of mental illness and contact with mentally ill patients in the past 3 months and if he/she received the previous year's seminars or workshops related to the stigma of mental illness.
The second part: Consists of Specific items that measure mental health-related knowledge among the general public using the Mental Health Knowledge Schedule (MAKS), its validity is supported by extensive review by experts including service users and international experts in stigma research and has been found to be brief and feasible with internal reliability and test-retest reliability moderate to substantial [11].. Part A of the scale comprises six items covering stigma-related mental health knowledge areas (need for paid employment, advice for professional help, medication is effective, psychotherapy is effective, full recovery from mental illness, seeking professional help by mentally ill) and Part B consists of six items that inquire about the classification of various conditions as mental illnesses to help contextualize the responses to other items. A 5-point Likert scale was used, and response options range from 1 = totally disagree to 5 = totally agree. "Don't know" was valued at 3 for the purposes of determining a total score. Items 6, 8 and 12 are reverse coded to reflect the direction of the correct response. The total score was calculated by adding the response values for only items 1-6 (Part A) and ranged from 6 to 30. A higher score indicates more knowledge. The Cronbach's alpha for the MAKS scale was 0.749.
The third part: Used, the Beliefs towards Mental Illness scale (BMI) to assess the attitudes toward mental illness, the scale was designed to measure cross-cultural differences in such beliefs as well as to predict treatment-seeking behavior among different cultural groups, with reliability estimates for each factor revealed to be moderate to high internal consistency [12]. It is composed of 21 items that measure negative stereotypical views of mental illness. The BMI scale consists of three subscales; Dangerousness subscale: Consists of five items (1, 2, 3, 6, 13) relating to the perceived dangerousness of mental illness and patients; Social and interpersonal skills subscale: Consists of 10 items (4, 5, 8, 11, 12, 14, 15, 17, 18, 21) covering the effect of mental illness on interpersonal relationships and related feelings of despair. It assesses the level of frustration and despair in interpersonal relationships with individuals with a mental illness. Also, taps feelings of shame about mental illness and the perception that the mentally ill are untrustworthy; and Incurability subscale: Consists of six items (7, 9, 10, 16, 19, 20) covering perceptiveness of incurability of mental illness. Items are rated on a five-point Likert scale, reverse coded from 1 (strongly agreement) to 5(strongly disagree). The total score was calculated by adding the response values for 21 items and ranged from 21 to 105. The lower score reflects a more negative belief toward the mentally ill. The Cronbach's alpha for the BMI scale was 0.82 and the subscales were between 0.69 - 0.80.
The fourth part: Assesses the mental health-related reported and intended Behavior measured by the Reported and Intended Behavior Scale (RIBS), Which was found to be a brief, feasible and psychometrically robust measure for assessing health-related reported and intended behavioral discrimination, with moderate to substantial internal consistency and test-retest reliability [13]. The four reported behavior outcomes included, living with, working with, living nearby, and continuing a relationship with someone with a mental health problem, while the four-intended behavior outcomes assessed the future intended behavior of the same items. A 5-point Likert scale was used, and response options range from 1 = totally disagree to 5 = totally agree. "Don't know" was valued at 3 for the purposes of determining a total score. The total score for each student is calculated by adding together the response values for intended behavior items and ranges from 4 to 20. A higher score indicates more favorable intended behavior. The Cronbach's alpha for the RIBS scale was 0.75. Ethical approval for carrying out the study was obtained from The Ethical Committee of the Faculty of Medicine, Suez Canal University, and the participant students were informed about the purpose of the study and signed informed consent before the start of the study.
Intervention program:
This study was carried from September 2019 to February 2020. Educational non discriminative anti-stigma educational intervention was delivered before the formal psychiatry rotation in the fourth year of the undergraduate study, and participation was voluntary. the intervention consisted of a 2-hour interactive lecture which explained the key facts and figures about stigma and discrimination related to mental illness, causes and consequence of stigma, video showed examples of social stigma related to mental illness and its impact on mental ill patients and their family, and how to combat stigma related to mental illness and ended by open discussion with students for any questions. Subsequently, half an hour personal testimony about the experience of mental health problems and stigma from person with direct experience of schizophrenia after his recovery, using trained role-player who had some theatre experiences. Then followed by, half an hour role-plays in small groups, using trained role-players to act the part of service users who suffer from depression and caregiver of schizophrenic patient.
Statistical analysis:
The data of the current study were analyzed using the SPSS version 20 (i.e., statistical package for social sciences) program. According to the results of the Shapiro-Wilk test for normality, continuous data were expressed as the median and interquartile range (IQR). Spearman correlation coefficient test was conducted to find the correlation between medical students' knowledge, attitude and behavior, toward mentally ill patients and different demographic variables. The scores of mental health-related knowledge, belief towards mental illness (with its 3 subscales), and intended behavior were categorized as poor or good based on the threshold score (cut-off point) obtained from the Likert scale which is ordinal but is often analyzed as numerical neglecting the differences between ordinal scores according to the following formula: The threshold score = ([total highest score-total lowest score]/2) + total lowest score. Predictors of baseline knowledge, belief, and behavior scores were determined using univariate linear regression analysis. If more than one significant predictor existed, the significant variables were implemented in a multivariate regression analysis. After accomplishment of the educational program, comparison of the knowledge, belief, and behavior scores across time was done using Related-Samples Friedman's Two-Way Analysis of Variance by Ranks. Pairwise analysis was performed to assess the difference between each two time periods. Males and females were compared concerning the studied scores using Mann-Whitney test. P values less than 0.05 were considered significant. The results were presented as tables, and graphs.
- Conditions
- Stigmatization, Medical Education
- Being tested
- educational psychiatry intervention
- Medical subject headings
- Stereotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational psychiatry interventionBehavioural
educational anti-stigma intervention related to psychiatric illness composed of a lecture, video, role models play, and open discussion
| Study group | Role | What they receive |
|---|---|---|
| undergraduate medical students | Experimental | an educational anti-stigma intervention delivered to undergraduate medical students comparing the outcomes of the study before and after the intervention at two time intervals Receives: Behavioral: educational psychiatry intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cut-off point score of MAKS assessed at the baseline, immediately after the intervention, and at 6-months follow up.
The Mental Health Knowledge Schedule (MAKS). It is a 5-point Likert scale ranging from 6 to 30, and the higher score indicates more mental health knowledge.
Measured: 0-6 months
The cut-off point score of BMI assessed at the baseline, immediately after the intervention, and at 6-months follow up.
The Beliefs toward Mental Illness scale (BMI) consists of 3 subscales measuring dangerousness, Social and Interpersonal skills, and incurability. BMI is a 5-point Likert scale, consists of total 21 items, and ranging from 21 to 105. The higher score indicates more favorable beliefs towards mental illnesses
Measured: 0-6 months
The cut-off point score of RIBS assessed at the bassline, immediately after the intervention, and at 6- months follow up.
RIBS is a 5-points Likert scale, ranging from 4 to 20 with higher score indicates more favorable intended behavior with mentally ill patients.
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start3 Nov 2019
- Primary completion17 May 2020
- Study completion17 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StigmatizationStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- quasi experimental ( pre-post ) study evaluating the outcomes of anti-stigma educational intervention
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Dahshan, Suez Canal University
- Investigators
- Ismail Dahshan, PhD, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596305
- Sponsor's protocol ID
- 1772018AntiStigMed
- Status last verified
- Oct 2022
- First submitted
- 18 Sep 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Anti Stigma Educational Intervention of Undergraduate Medical Students Towards Mentally Ill Patients-Suez Canal University Hospital
- ClinicalTrials.gov ID
- NCT05596305
- Acronym / sponsor ID
- 1772018AntiStigMed
- Conditions
- Stigmatization, Medical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 3 Nov 2019 (actual)
- Primary completion
- 17 May 2020 (actual)
- Study completion
- 17 May 2020 (actual)
- First posted
- 27 Oct 2022 (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.
Background: Stigma causes a significant burden for mental ill patients. Unfortunately, negative attitudes towards mentally ill are not confined to the lay public but are also common among health professionals.
Aim: To study outcomes of psychiatric anti stigma educational intervention on undergraduate medical students' knowledge, attitude, and behavior as primary outcome measures.
Subjects and methods: a quasi-experimental study was conducted on fourth year (120) undergraduate medical students affiliated to faculty of Medicine-Suez Canal University. The participants conducted a semi-structured questionnaire to assess effect of anti-stigma program on their knowledge, attitude and intended behavior toward mentally ill. The participants completed baseline questionnaire, then immediately and after 6 months reassessment. Data was collected from November 2019 to May 2020.
Detailed description
Subjects and Methods:
The current study was a quasi-experimental (pre-post) intervention study was conducted on 120 all fourth-year undergraduate medical students affiliated to faculty of medicine, Suez Canal University in Ismailia city, Egypt to assess the outcomes of psychiatric anti-stigma educational intervention on their knowledge, attitude and intended behavior toward mentally ill. Permissions for the study were obtained from the authorities concerned, and the participants medical students were informed about the purpose of the study and signed an informed consent before the beginning of this study.
Methods:
The First part: Consists of socio-demographic data of each medical student, which includes age, gender, family history of mental illness and contact with mentally ill patients in the past 3 months and if he/she received the previous year's seminars or workshops related to the stigma of mental illness.
The second part: Consists of Specific items that measure mental health-related knowledge among the general public using the Mental Health Knowledge Schedule (MAKS), its validity is supported by extensive review by experts including service users and international experts in stigma research and has been found to be brief and feasible with internal reliability and test-retest reliability moderate to substantial [11].. Part A of the scale comprises six items covering stigma-related mental health knowledge areas (need for paid employment, advice for professional help, medication is effective, psychotherapy is effective, full recovery from mental illness, seeking professional help by mentally ill) and Part B consists of six items that inquire about the classification of various conditions as mental illnesses to help contextualize the responses to other items. A 5-point Likert scale was used, and response options range from 1 = totally disagree to 5 = totally agree. "Don't know" was valued at 3 for the purposes of determining a total score. Items 6, 8 and 12 are reverse coded to reflect the direction of the correct response. The total score was calculated by adding the response values for only items 1-6 (Part A) and ranged from 6 to 30. A higher score indicates more knowledge. The Cronbach's alpha for the MAKS scale was 0.749.
The third part: Used, the Beliefs towards Mental Illness scale (BMI) to assess the attitudes toward mental illness, the scale was designed to measure cross-cultural differences in such beliefs as well as to predict treatment-seeking behavior among different cultural groups, with reliability estimates for each factor revealed to be moderate to high internal consistency [12]. It is composed of 21 items that measure negative stereotypical views of mental illness. The BMI scale consists of three subscales; Dangerousness subscale: Consists of five items (1, 2, 3, 6, 13) relating to the perceived dangerousness of mental illness and patients; Social and interpersonal skills subscale: Consists of 10 items (4, 5, 8, 11, 12, 14, 15, 17, 18, 21) covering the effect of mental illness on interpersonal relationships and related feelings of despair. It assesses the level of frustration and despair in interpersonal relationships with individuals with a mental illness. Also, taps feelings of shame about mental illness and the perception that the mentally ill are untrustworthy; and Incurability subscale: Consists of six items (7, 9, 10, 16, 19, 20) covering perceptiveness of incurability of mental illness. Items are rated on a five-point Likert scale, reverse coded from 1 (strongly agreement) to 5(strongly disagree). The total score was calculated by adding the response values for 21 items and ranged from 21 to 105. The lower score reflects a more negative belief toward the mentally ill. The Cronbach's alpha for the BMI scale was 0.82 and the subscales were between 0.69 - 0.80.
The fourth part: Assesses the mental health-related reported and intended Behavior measured by the Reported and Intended Behavior Scale (RIBS), Which was found to be a brief, feasible and psychometrically robust measure for assessing health-related reported and intended behavioral discrimination, with moderate to substantial internal consistency and test-retest reliability [13]. The four reported behavior outcomes included, living with, working with, living nearby, and continuing a relationship with someone with a mental health problem, while the four-intended behavior outcomes assessed the future intended behavior of the same items. A 5-point Likert scale was used, and response options range from 1 = totally disagree to 5 = totally agree. "Don't know" was valued at 3 for the purposes of determining a total score. The total score for each student is calculated by adding together the response values for intended behavior items and ranges from 4 to 20. A higher score indicates more favorable intended behavior. The Cronbach's alpha for the RIBS scale was 0.75. Ethical approval for carrying out the study was obtained from The Ethical Committee of the Faculty of Medicine, Suez Canal University, and the participant students were informed about the purpose of the study and signed informed consent before the start of the study.
Intervention program:
This study was carried from September 2019 to February 2020. Educational non discriminative anti-stigma educational intervention was delivered before the formal psychiatry rotation in the fourth year of the undergraduate study, and participation was voluntary. the intervention consisted of a 2-hour interactive lecture which explained the key facts and figures about stigma and discrimination related to mental illness, causes and consequence of stigma, video showed examples of social stigma related to mental illness and its impact on mental ill patients and their family, and how to combat stigma related to mental illness and ended by open discussion with students for any questions. Subsequently, half an hour personal testimony about the experience of mental health problems and stigma from person with direct experience of schizophrenia after his recovery, using trained role-player who had some theatre experiences. Then followed by, half an hour role-plays in small groups, using trained role-players to act the part of service users who suffer from depression and caregiver of schizophrenic patient.
Statistical analysis:
The data of the current study were analyzed using the SPSS version 20 (i.e., statistical package for social sciences) program. According to the results of the Shapiro-Wilk test for normality, continuous data were expressed as the median and interquartile range (IQR). Spearman correlation coefficient test was conducted to find the correlation between medical students' knowledge, attitude and behavior, toward mentally ill patients and different demographic variables. The scores of mental health-related knowledge, belief towards mental illness (with its 3 subscales), and intended behavior were categorized as poor or good based on the threshold score (cut-off point) obtained from the Likert scale which is ordinal but is often analyzed as numerical neglecting the differences between ordinal scores according to the following formula: The threshold score = ([total highest score-total lowest score]/2) + total lowest score. Predictors of baseline knowledge, belief, and behavior scores were determined using univariate linear regression analysis. If more than one significant predictor existed, the significant variables were implemented in a multivariate regression analysis. After accomplishment of the educational program, comparison of the knowledge, belief, and behavior scores across time was done using Related-Samples Friedman's Two-Way Analysis of Variance by Ranks. Pairwise analysis was performed to assess the difference between each two time periods. Males and females were compared concerning the studied scores using Mann-Whitney test. P values less than 0.05 were considered significant. The results were presented as tables, and graphs.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- quasi experimental ( pre-post ) study evaluating the outcomes of anti-stigma educational intervention
| Arm | Type | Receives |
|---|---|---|
| undergraduate medical students | Experimental | Behavioral: educational psychiatry interventionan educational anti-stigma intervention delivered to undergraduate medical students comparing the outcomes of the study before and after the intervention at two time intervals |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All fourth-year medical students in the faculty of medicine, Suez Canal University.
Key exclusion criteria (2 listed)
- Refusal to participate and/or decline to complete the study for any cause.
- Any Identified history or treatment for psychiatric conditions.
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 |
|---|---|---|
| educational psychiatry interventioneducational anti-stigma intervention related to psychiatric illness composed of a lecture, video, role models play, and open discussion | Behavioural | undergraduate medical students |
Primary outcome
The cut-off point score of MAKS assessed at the baseline, immediately after the intervention, and at 6-months follow up.
Time frame: 0-6 months
The Mental Health Knowledge Schedule (MAKS). It is a 5-point Likert scale ranging from 6 to 30, and the higher score indicates more mental health knowledge.
The cut-off point score of BMI assessed at the baseline, immediately after the intervention, and at 6-months follow up.
Time frame: 0-6 months
The Beliefs toward Mental Illness scale (BMI) consists of 3 subscales measuring dangerousness, Social and Interpersonal skills, and incurability. BMI is a 5-point Likert scale, consists of total 21 items, and ranging from 21 to 105. The higher score indicates more favorable beliefs towards mental illnesses
The cut-off point score of RIBS assessed at the bassline, immediately after the intervention, and at 6- months follow up.
Time frame: 0-6 months
RIBS is a 5-points Likert scale, ranging from 4 to 20 with higher score indicates more favorable intended behavior with mentally ill patients.
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 27 Oct 2022.
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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.
Ismail Dahshan, PhD principal investigator
Suez Canal 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 educational psychiatry intervention in people with Stigmatization and Medical Education, run by Suez Canal 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 1 inclusion and 2 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 27 Oct 2022. 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?
The cut-off point score of MAKS assessed at the baseline, immediately after the intervention, and at 6-months follow up. (time frame: 0-6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2022.