Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05596305 |
| Other study ID # |
1772018AntiStigMed |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 3, 2019 |
| Est. completion date |
May 17, 2020 |
Study information
| Verified date |
October 2022 |
| Source |
Suez Canal University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
