Condition category
Mental and Behavioural Disorders
Date applied
12/03/2018
Date assigned
29/03/2018
Last edited
28/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

federal

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)

Publication list

Publication citations

Additional files

Editorial Notes