Assessment of the effectiveness of a program for the reduction of stigma towards people with severe mental disorders in primary care workers.

ISRCTN ISRCTN46464036
DOI https://doi.org/10.1186/ISRCTN46464036
Secondary identifying numbers FONDECYT 1171287
Submission date
12/03/2018
Registration date
29/03/2018
Last edited
10/11/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Pamela Grandon
Scientific

Pinares 20
Chiguayante
Concepcion
4100000
Chile

Phone +56 41 220 4323
Email pgrandon@udec.cl

Study information

Study designClinical cluster randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typePrevention
Participant information sheet No participant information sheet available
Scientific titleAssessment of the effectiveness of a program for the reduction of stigma towards people with severe mental disorders in primary care workers: A randomized trial.
Study objectivesThe “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(s)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
Health condition(s) or problem(s) studiedMental illness
InterventionHealth 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 typeBehavioural
Primary outcome measure1. 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 measuresBehaviour 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 study start date10/03/2017
Completion date31/12/2018

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participantsThe minimum number of participants will be 105 in the experimental group and 105 in the control group.
Total final enrolment316
Key inclusion criteriaWorkers 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.
Key exclusion criteriaNo exclusion criteria
Date of first enrolment10/03/2018
Date of final enrolment31/03/2018

Locations

Countries of recruitment

  • Chile

Study participating centres

Health Familiar Center Santa Sabina
Concepción
4030000
Chile
Health Familiar Center O'Higgins
Concepción
4030000
Chile
Health Familiar Center Juan Soto Fernández
Concepción
4030000
Chile
Health Familiar Center Lorenzo Arenas
Concepción
4030000
Chile
Health Familiar Center Tucapel
Concepción
4030000
Chile
Health Familiar Center Chiguay
Chiguayante
Concepción
4100000
Chile
Health Familiar Center Leonera
Chiguayante
Concepción
4100000
Chile
Health Familiar Center Pinares
Chiguayante
Concepción
4100000
Chile
Health Familiar Center Paulina Avendaño
Talcahuano
Concepción
4260000
Chile
Health Familiar Center Los Cerros
Talcahuano
Concepción
4260000
Chile
Health Familiar Center Hualpencillo
Hualpén
Concepción
4600000
Chile
Health Familiar Center La Floresta
Hualpén
Concepción
4600000
Chile
Health Familiar Center Talcahuano Sur
Hualpén
Concepción
4600000
Chile
Health Familiar Center Tome
Tomé
4160000
Chile

Sponsor information

Universidad de Concepcion
University/education

Victor Lamas 1290
Concepcion
4030000
Chile

Phone +56 41 220 4301
Email jbecerra@udec.cl
ROR logo "ROR" https://ror.org/0460jpj73

Funders

Funder type

Government

Comisión Nacional de Investigación Científica y Tecnológica
Government organisation / National government
Alternative name(s)
National Commission for Scientific and Technological Research, CONICYT
Location
Chile

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Claudio Bustos, clbustos@udec.cl

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 07/03/2019 Yes No
Basic results 27/10/2020 27/10/2020 No No
Results article 01/11/2021 10/11/2021 Yes No

Additional files

ISRCTN46464036_BasicResults_27Oct2020.pdf
uploaded 27/10/2020

Editorial Notes

10/11/2021: Publication reference and total final enrolment added.
27/10/2020: The basic results of this trial have been uploaded as an additional file.
07/11/2019: Internal review.
25/03/2019: Publication reference added.