Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001072707p
Ethics application status
Submitted, not yet approved
Date submitted
8/07/2022
Date registered
3/08/2022
Date last updated
3/08/2022
Date data sharing statement initially provided
3/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of an education internvention on stigma in university students towards people with mental disorders.
Scientific title
Evaluation of effectiveness of an education intervention on stigma levels towards people with mental disorder in undergraduated students of health careers at the University of Concepción
Secondary ID [1] 307504 0
Nil known
Universal Trial Number (UTN)
U1111-1280-0715
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stigma towards mental illness 326927 0
Condition category
Condition code
Mental Health 324113 324113 0 0
Other mental health disorders
Public Health 324114 324114 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to evaluate the effectiveness of an intervention to reduce stigma in students of health careers. For this, the intervention elaborated with psychology students will be redesigned and protocolized. The strategies of education, contact and skills development will be used. Its effectiveness will be tested through an allegorical clinical trial in 7 health careers: medicine, nursing, obstetric dentistry, kinesiology, psychology and social work. The proposal will also have a "community-based participation" approach and will have a group of people with a diagnosis of TM (peer to peer support) who will be part of the work team and will collaborate both in the redesign and in the execution of the intervention.
In the intervention, will be involved in this process experts by experiences (a person who has lived experience on mental illness). Psychologists, whose will be facilitator in the workshop and undergraduates students.
The process will involve 3x2 hour workshop conducted via face to face. And the process will occur: first a pilot application 2 months prior to the intervention administration.
The intervention is a experiential based workshop. Each participant attends 1 workshop per week for a 1 month period. The duration of every session is 2 hours. We will use a game about "demolishing myths". It is played on a large board that is placed on the floor of the place. The board has a series of squares through which the teams must advance according to the number indicated by the dice. In the boxes there are different figures that have requirements:myth or true, what would i do?.
The students write in a paper some beliefs about mental ilness and then they read this paper and discuss between them and talk with experts by experiences; we will use experiences based video about professional role in mental health. workshop sessions are over, the teacher will ask the students in groups (the number of students per group will be determined by the teacher, taking care that the groups do not exceed eight people) to build an "anti-stigma project".
The intervention will be delivered to students in face to face educational workshop and we use group discussion and presentation of videos.
The intervention will be delivered as weekly sessions over a month period. Psychologists in a facilitator role and experts by experiences will deliver the intervention. To monitor adherence to the intervvention , we will use sessions attendance checklist.
We have changed the TM (acronym in spanish) by MI [mental illness]
Intervention code [1] 323965 0
Treatment: Other
Intervention code [2] 323966 0
Behaviour
Comparator / control treatment
The control group will not receive intervention during the process. One month post trial completion we will offer the same intervention to control group
Control group
Active

Outcomes
Primary outcome [1] 331922 0
Mean scores on the "Creencias estigmatizantes" subscale of "Actitudes Profesionales en Salud Mental hacia personas con diagnóstico de TM (EASP-TM) (Vielma et al, 2021)
Timepoint [1] 331922 0
Baseline (pre intervention) and immediately post-intervention
Primary outcome [2] 331943 0
Mean scores of Social Distance Scale (Grandón et al., 2015)
Timepoint [2] 331943 0
Baseline (pre intervention) and immediately post-intervention
Primary outcome [3] 332031 0
Mean scores on the "Infantilización y distancia relacional" subscale of "Actitudes Profesionales en Salud Mental hacia personas con diagnóstico de TM (EASP-TM) (Vielma et al, 2021)
Timepoint [3] 332031 0
Baseline (pre intervention) and immediately post-intervention
Secondary outcome [1] 411944 0
Mean scores on the "Creencias estigmatizantes" subscale of "Actitudes Profesionales en Salud Mental hacia personas con diagnóstico de TM (EASP-TM) (Vielma et al, 2021)
Timepoint [1] 411944 0
at 6 and 12 months after randomisation
Secondary outcome [2] 411945 0
Mean scores on the "Infantilización y distancia relacional" subscale of "Actitudes Profesionales en Salud Mental hacia personas con diagnóstico de TM (EASP-TM) (Vielma et al, 2021)
Timepoint [2] 411945 0
at 6 and 12 months post randomization
Secondary outcome [3] 411946 0
Mean scores of Social Distance Scale (Grandón et al., 2015)
Timepoint [3] 411946 0
at 6 and 12 months post randomization

Eligibility
Key inclusion criteria
nursing, kinesiology, medicine, obstetrics, dentistry, psychology, and social work undergraduated students from Universidad de Concepción.
Signing of the informed consent.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Having been exposed to practical curricular activities that involve direct contact with people diagnosed with a mental disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The donation process to groups is carried out by a person external to the research team, who will be blind to randomization.
The formation of two equitable groups per race should be considered: control group and experimental group. A total of 14 will be formed (groups are 7 races and there are 2 groups for each one).

The assignment to the control group and experimental group in each block will be carried out by simple random procedure, using a table of random numbers without repetition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
It will be taken care that the assignment to the groups is carried out by someone external to the investigation in order to safeguard the blindness of the procedure.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The information will be processed with the Stata Program (V.14.0). 1). The data will be entered with a double-entry procedure. The inspection, cleaning and preparation of the data will be carried out and the reliability of the instruments used with Cronbach's alpha will be studied. 2) An exploratory/descriptive analysis of the data will be carried out with central tendency and variability statistics. 3) Bivariate analysis will be performed using the student's t-test and Pearson's product moment correlation coefficient. Student's t-test will be used for independent samples based on a unilateral contrast in order to investigate the existence of statistically significant differences between the control group and the experimental group. 4) Finally, to evaluate the effect of the intervention on the main outcome variable and the secondary outcome variable, an analysis of variance will be performed controlling for the initial score on the EAPS-TM Scale in the experimental group and the control group. The criterion to determine the statistical significance of the results will be the value a = .05. The data will be analyzed by “intention to treat”.
The sample size was calculated to detect differences in the contrast of the null hypothesis Ho:µ1= µ2 by means of a two-sided T-student test for independent samples, taking into account a significance level of 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/08/2022
Actual
Date of last participant enrolment
Anticipated
19/08/2022
Actual
Date of last data collection
Anticipated
7/10/2023
Actual
Sample size
Target
317
Accrual to date
Final
Recruitment outside Australia
Country [1] 24882 0
Chile
State/province [1] 24882 0
Biobío

Funding & Sponsors
Funding source category [1] 311782 0
University
Name [1] 311782 0
Universidad de Concepcion/PROYECTO VRID 2020000137
Country [1] 311782 0
Chile
Primary sponsor type
Individual
Name
Daisy Vidal Gutierrez
Address
Universidad de Concepción,
VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile
postal code: 4070386
Country
Chile
Secondary sponsor category [1] 313263 0
Individual
Name [1] 313263 0
Grandon Fernandez, Pamela
Address [1] 313263 0
Universidad de Concepcion.
VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile
postal code: 4070386
Country [1] 313263 0
Chile
Other collaborator category [1] 282358 0
Individual
Name [1] 282358 0
GRANDÓN FERNÁNDEZ, PAMELA
Address [1] 282358 0
Universidad de Concepcion.
VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile
postal code: 4070386
Country [1] 282358 0
Chile
Other collaborator category [2] 282359 0
Individual
Name [2] 282359 0
ARAYA VALLESPIR, CARLOS
Address [2] 282359 0
Universidad de Concepcion.
VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile
postal code: 4070386
Country [2] 282359 0
Chile
Other collaborator category [3] 282360 0
Individual
Name [3] 282360 0
CID HENRÍQUEZ, PATRICIA
Address [3] 282360 0
Universidad de Concepcion.
VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile
postal code: 4070386
Country [3] 282360 0
Chile
Other collaborator category [4] 282361 0
Individual
Name [4] 282361 0
CONTRERAS GARCÍA, YOLANDA
Address [4] 282361 0
Universidad de Concepcion.
VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile
postal code: 4070386
Country [4] 282361 0
Chile
Other collaborator category [5] 282362 0
Individual
Name [5] 282362 0
FLORES CARTES, RAÚL
Address [5] 282362 0
Universidad de Concepcion.
VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile
postal code: 4070386
Country [5] 282362 0
Chile
Other collaborator category [6] 282363 0
Individual
Name [6] 282363 0
SKRIPTSCHENKO STRASSER, TATIANA
Address [6] 282363 0
Universidad de Concepcion.
VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile
postal code: 4070386
Country [6] 282363 0
Chile
Other collaborator category [7] 282364 0
Individual
Name [7] 282364 0
VIELMA AGUILERA, ALEXIS
Address [7] 282364 0
Universidad de Concepcion.
VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile
postal code: 4070386
Country [7] 282364 0
Chile

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311223 0
Comité de Ética, Bioética y Bioseguridad Vicerrectoría de Investigación y Desarrollo Universidad de Concepción
Ethics committee address [1] 311223 0
Ethics committee country [1] 311223 0
Chile
Date submitted for ethics approval [1] 311223 0
17/11/2021
Approval date [1] 311223 0
Ethics approval number [1] 311223 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120390 0
Dr Daisy Vidal Gutierrez
Address 120390 0
Universidad de Concepción, VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile postal code: 4070386
Country 120390 0
Chile
Phone 120390 0
+56 41 220 4244
Fax 120390 0
Email 120390 0
[email protected]
Contact person for public queries
Name 120391 0
Daisy Vidal Gutierrez
Address 120391 0
Universidad de Concepción, VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile postal code: 4070386
Country 120391 0
Chile
Phone 120391 0
+56 41 220 4244
Fax 120391 0
Email 120391 0
[email protected]
Contact person for scientific queries
Name 120392 0
Pamela Grandon Fernandez
Address 120392 0
Universidad de Concepción, VICTOR LAMAS 1290 street, Concepción, Región del Biobío, Chile postal code: 4070386
Country 120392 0
Chile
Phone 120392 0
+56 41 220 4244
Fax 120392 0
Email 120392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication and available for 5 years after publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Daisy Vidal: [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of an intervention to reduce stigma towards people with a mental disorder diagnosis in university students of healthcare careers.2023https://dx.doi.org/10.1016/j.psychres.2023.115428
N.B. These documents automatically identified may not have been verified by the study sponsor.