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
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
Scientific
Pinares 20
Chiguayante
Concepcion
4100000
Chile
| Phone | +56 41 220 4323 |
|---|---|
| pgrandon@udec.cl |
Study information
| Study design | Clinical cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| 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. |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 10/03/2017 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | The minimum number of participants will be 105 in the experimental group and 105 in the control group. |
| Total final enrolment | 316 |
| Key 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. |
| Key exclusion criteria | No exclusion criteria |
| Date of first enrolment | 10/03/2018 |
| Date of final enrolment | 31/03/2018 |
Locations
Countries of recruitment
- Chile
Study participating centres
4030000
Chile
4030000
Chile
4030000
Chile
4030000
Chile
4030000
Chile
Concepción
4100000
Chile
Concepción
4100000
Chile
Concepción
4100000
Chile
Concepción
4260000
Chile
Concepción
4260000
Chile
Concepción
4600000
Chile
Concepción
4600000
Chile
Concepción
4600000
Chile
4160000
Chile
Sponsor information
University/education
Victor Lamas 1290
Concepcion
4030000
Chile
| Phone | +56 41 220 4301 |
|---|---|
| jbecerra@udec.cl | |
"ROR" |
https://ror.org/0460jpj73 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Commission for Scientific and Technological Research, CONICYT
- Location
- Chile
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The 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.
