Plain English Summary
Background and study aims
People with severe mental disorders (SMD) have higher disease and death rates than the general population. Stigma (negative attitudes and perceptions) contributes to an unfairness in the access to health services and a lower quality of assistance in this population. Stigma is translated into negative attitudes, social distance and discrimination towards this social group. For these reasons, healthcare workers are a priority groups for anti-stigma interventions.
This study aims to assess the effectiveness of a program specifically designed to decrease negative attitudes and social distance and increase inclusive behaviors of health workers towards people with severe mental disorders.
Who can participate?
Adult health workers from Family Health Centers
What does the study involve?
Participants are randomly allocated by their health centre to one of two groups. Those in the first group receive a program delivered weekly by a psychologist. The program includes education, development of behavior skills and contact with somebody diagnosed with a severe mental disorder.
Those in the second group do not receive any additional program until after the study is finished.
What are the possible benefits and risks of participating?
All participants have the opportunity to learn how to reduce the stigma surrounding people diagnosed with severe mental disorders. There are no identifiable risks for those taking part in the study.
Where is the study run from?
Family Health Center Santa Sabina and 13 other Family Health Centers in Chile
When is the study starting and how long is it expected to run for?
March 2017 – December 2018
Who is funding the study?
National Commission for Scientific and Technological Research, CONICYT (Chile)
Who is the main contact?
Dr Pamela Grandon (Scientific)
pgrandon@udec.cl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Pamela Grandon
ORCID ID
Contact details
Pinares 20
Chiguayante
Concepcion
4100000
Chile
+56 41 220 4323
pgrandon@udec.cl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FONDECYT 1171287
Study information
Scientific title
Assessment of the effectiveness of a program for the reduction of stigma towards people with severe mental disorders in primary care workers: A randomized trial.
Acronym
Study hypothesis
The “Igual-mente” (“Equally”) Program will decrease negative attitudes and social distance and it will increase inclusive behaviors from the health workers towards people with severe mental disorders.
Ethics approval
1. Ethical and Scientific Committee from Servicio de Salud de Concepción, 24/10/2017, ref: 16-08-44
2. Servicio de Salud de Talcahuano, 04/07/2017, ref: Act Nº 67
Study design
Clinical cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Mental illness
Intervention
Health workers from different primary care centers are randomized by center to experimental or control groups. All the workers from each center are invited to participate and those that accept receive the pre-test assessment. All of those that have received the pre-test assessment are randomly assigned to one group or another by random numbers. Randomization is carried out by an external person, blind to the other aspects of the research.
Those in the intervention group receive a program called Igual-mente (Equally). The program lasts two months with weekly sessions including education strategies, contact with people diagnosed with severe mental disorders and the development of well-behavior skills towards people with a SMD. The program is carried out by a psychologist and a person who has received the diagnosis of severe mental disorder. Both receive previous training and must pass a competence test. They are weekly both personally and distance supervised.
The control group do not receive the program for assessment during the study, but can receive it after the study is completed.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Social Distance is assessed using Social Distance Scale.
2. Negative attitudes to people with mental health are assessed using "Scale of Attitudes of Health Professionals towards People with Severe Mental Illness" which is built by a doctoral thesis based on the "Mental Illness Clinicians Attitudes” (Gabbidon et al., 2013) and Community Attitudes to Mental Illness (Grandón, et al., 2016; Taylor, & Dear, 1981).
Both will be evaluated up to 15 days after the end of the program.
Secondary outcome measures
Behaviour toward consulting with severe mental health disorders is assessed using a the Checklist of Inclusive Behaviours (a scale developed by the authors of this research) up to 15 days after the end of the program.
Overall trial start date
10/03/2017
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Workers from the Family Health Centers considering both:
1.1. Professionals (nurses, physicians, medical technicians, psychologists and social workers, professional midwife, nutritionists, occupational therapists, pharmacists, matron)
1.2.medical technicians.
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
The minimum number of participants will be 105 in the experimental group and 105 in the control group.
Participant exclusion criteria
No exclusion criteria
Recruitment start date
10/03/2018
Recruitment end date
31/03/2018
Locations
Countries of recruitment
Chile
Trial participating centre
Health Familiar Center Santa Sabina
Concepción
4030000
Chile
Trial participating centre
Health Familiar Center O'Higgins
Concepción
4030000
Chile
Trial participating centre
Health Familiar Center Juan Soto Fernández
Concepción
4030000
Chile
Trial participating centre
Health Familiar Center Lorenzo Arenas
Concepción
4030000
Chile
Trial participating centre
Health Familiar Center Tucapel
Concepción
4030000
Chile
Trial participating centre
Health Familiar Center Chiguay
Chiguayante
Concepción
4100000
Chile
Trial participating centre
Health Familiar Center Leonera
Chiguayante
Concepción
4100000
Chile
Trial participating centre
Health Familiar Center Pinares
Chiguayante
Concepción
4100000
Chile
Trial participating centre
Health Familiar Center Paulina Avendaño
Talcahuano
Concepción
4260000
Chile
Trial participating centre
Health Familiar Center Los Cerros
Talcahuano
Concepción
4260000
Chile
Trial participating centre
Health Familiar Center Hualpencillo
Hualpén
Concepción
4600000
Chile
Trial participating centre
Health Familiar Center La Floresta
Hualpén
Concepción
4600000
Chile
Trial participating centre
Health Familiar Center Talcahuano Sur
Hualpén
Concepción
4600000
Chile
Trial participating centre
Health Familiar Center Tome
Tomé
4160000
Chile
Sponsor information
Organisation
Universidad de Concepcion
Sponsor details
Victor Lamas 1290
Concepcion
4030000
Chile
+56 41 220 4301
jbecerra@udec.cl
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Comisión Nacional de Investigación Científica y Tecnológica
Alternative name(s)
National Commission for Scientific and Technological Research, CONICYT
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Chile
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Claudio Bustos, clbustos@udec.cl
Intention to publish date
31/12/2019
Participant level data
Available on request
Basic results (scientific)
See additional files
Publication list
2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30899230
Publication citations
Additional files
- ISRCTN46464036_BasicResults_27Oct2020.pdf uploaded 27/10/2020