General PopulationNCT05174962
National Stigma Survey About Mental Illness, Intellectual Disability and Homelessness in Spain
An observational study of General Population, run by Universidad Complutense de Madrid.
Trial summary
This project is framed within the "Complutense University of Madrid (UCM)-Group 5 Against Stigma Chair", of the Faculty of Psychology. The main objective of the Chair is to fight the stigma that affects people with mental disorders, disabilities, vulnerability or extreme social exclusion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Population
- How many people
- 2,750 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: An approximate sample size of 2750 interviews is estimated. The sample made up of the general population over 18 years of age obtained through the consumer panel methodology. To obtain a representative sample of the Spanish population, quotas by sex and age group are included, as well as data for each of the 17 autonomous communities through simple affixing, ensuring a minimum of 100 surveys per Autonomous Community. On the other hand, it also allows a rural-urban analysis in the sample as a whole and in the most populated autonomous communities.
Who may be able to join
- People aged 18 and over from general population.
- Any gender.
Who cannot join
- People under 18 years old.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: National Stigma Survey About Mental Illness, Homelessness and Intellectual Disability in Spain
This project is framed within the "Complutense University of Madrid (UCM)-Group 5 Against Stigma Chair", of the Faculty of Psychology. The main objective of the Chair is to fight the stigma that affects people with mental disorders, disabilities, vulnerability or extreme social exclusion. For this purpose, the Chair is developing research studies, training programs, cultural activities and awareness campaigns, proof of this is the recent publication of the Guide to good practices against stigma, which, although it takes as a reference to the people with a diagnosis of mental disorder, it is expected to be generalizable to other groups.
Stigma is associated with the condition of being different, and affects any person belonging to a minority or vulnerable group, being one of the main obstacles to full participation in different social, political and cultural institutions. The fight against stigma is included in important international treaties, such as the United Nations Convention on the Rights of Persons with Disabilities or the European recommendations regarding the fight against social exclusion of people with mental health problems.
This study will focus on three groups of special social sensitivity, with clear stigmatizing conditions: people with mental health problems, people in a homeless situation and people with intellectual disabilities.
Read the detailed description
The primary aim of this research is to describe the stigma faced by people corresponding to three highly vulnerable population groups: people with mental health problems, homeless people and people with intellectual disabilities.
From this general aim, four different specific goals are derived: 1) To delve into the experience of stigma of these groups, from first person; 2) To develop a quantitative assessment instrument that captures the current needs and experiences of people from these groups; 3) To describe and compare the social stigma of these three groups in a representative Spanish sample; 4) To address, from a gender perspective, possible differences in terms of the variables explored in the populations under study.
- Conditions
- General Population
- Keywords
- Stigma, Mental illness, Homeless situation, Intellectual disability
- Medical subject headings
- Social Stigma, Mental Disorders, Intellectual Disability
What is being measured
The primary outcome is the main question the study is designed to answer.
Social distance desire
Reported and Intended Behaviour Scale (RIBS). The scale was adapted by asking about future intentions to live with, have friendships with or let children interact with people with mental health problems, homelessness or intellectual disabilities. Responses consisted of Likert-type items (1 strongly agree, 5 strongly disagree). Higher scores are indicative of better future behaviour.
Measured: Up to 8 weeks
Attitudes towards mental disorders
Attributional Questionnaire-9 (AQ-9). It is a reduced version of the Attribution Questionnaire-27, consisting of 9 items instead of 27. The questionnaire includes 9 items in Likert-type format with 9 response alternatives ranging from "1 = not at all" to "9 = very much".
Measured: Up to 8 weeks
Attitudes towards disability
Attitudes to Disability Scale (ADS): This scale is one of the most complete scales for assessing stigma towards intellectual disability. It was developed as part of an international World Health Organization study, in which Spain participated alongside other countries. The scale consists of 16 Likert-type items (1 = strongly agree and 5 = strongly disagree). These items are gathered in 4 subscales: Inclusion-exclusion, Discrimination, Gains and Hopes. It has adequate psychometric properties.
Measured: Up to 8 weeks
Attitudes towards homelessness
Survey attitudes towards Homeless People: This scale consists of 9 Likert-type items (1 = strongly agree and 6 = strongly disagree). It explores various attitudes towards homeless people (people sleeping on the streets or in shelters). It has good psychometric properties.
Measured: Up to 8 weeks
Disclosure about mental disorders
This scale assess opinions and attitudes towards disclosure of mental health problems, as well as the ability to talk about them and to identify the main agents and sources of support for people, through this question: "If a close person (family member, friend, partner) had a mental health problem...? ". Questions are rated on a 5 Likert-type scale, where 1 = I would definitely talk about it with them, and 5 = I would avoid talking about it with them.
Measured: Up to 8 weeks
Key aspects of stigma
In addition to the standardized instruments, a number of selected questions on key aspects of stigma are included in the survey. These qualitative aspects were highlighted by people with mental illness, people experiencing homelessness, and people with intellectual disabilities who participated in a series of focus groups. Questions are rated on a 5 Likert-type scale (1 = strongly disagree and 5 = strongly agree)
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start1 Jan 2022 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General PopulationStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo 5
- Responsible party
- Sponsor
- Investigators
- Manuel Muñoz, Ph.D., Study chair, Universidad Complutense de MadridManuel Muñoz, Ph.D., Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174962
- Sponsor's protocol ID
- 2020/21-026
- Status last verified
- Oct 2021
- First submitted
- 17 Nov 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Stigma Survey About Mental Illness, Homelessness and Intellectual Disability in Spain
- ClinicalTrials.gov ID
- NCT05174962
- Acronym / sponsor ID
- 2020/21-026
- Conditions
- General Population
- Keywords
- Stigma, Mental illness, Homeless situation, Intellectual disability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,750 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Grupo 5
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is framed within the "Complutense University of Madrid (UCM)-Group 5 Against Stigma Chair", of the Faculty of Psychology. The main objective of the Chair is to fight the stigma that affects people with mental disorders, disabilities, vulnerability or extreme social exclusion. For this purpose, the Chair is developing research studies, training programs, cultural activities and awareness campaigns, proof of this is the recent publication of the Guide to good practices against stigma, which, although it takes as a reference to the people with a diagnosis of mental disorder, it is expected to be generalizable to other groups.
Stigma is associated with the condition of being different, and affects any person belonging to a minority or vulnerable group, being one of the main obstacles to full participation in different social, political and cultural institutions. The fight against stigma is included in important international treaties, such as the United Nations Convention on the Rights of Persons with Disabilities or the European recommendations regarding the fight against social exclusion of people with mental health problems.
This study will focus on three groups of special social sensitivity, with clear stigmatizing conditions: people with mental health problems, people in a homeless situation and people with intellectual disabilities.
Detailed description
The primary aim of this research is to describe the stigma faced by people corresponding to three highly vulnerable population groups: people with mental health problems, homeless people and people with intellectual disabilities.
From this general aim, four different specific goals are derived: 1) To delve into the experience of stigma of these groups, from first person; 2) To develop a quantitative assessment instrument that captures the current needs and experiences of people from these groups; 3) To describe and compare the social stigma of these three groups in a representative Spanish sample; 4) To address, from a gender perspective, possible differences in terms of the variables explored in the populations under study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- An approximate sample size of 2750 interviews is estimated. The sample made up of the general population over 18 years of age obtained through the consumer panel methodology. To obtain a representative sample of the Spanish population, quotas by sex and age group are included, as well as data for each of the 17 autonomous communities through simple affixing, ensuring a minimum of 100 surveys per Autonomous Community. On the other hand, it also allows a rural-urban analysis in the sample as a whole and in the most populated autonomous communities.
Key inclusion criteria (2 listed)
- People aged 18 and over from general population.
- Any gender.
Key exclusion criteria (1 listed)
- People under 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Social distance desire
Time frame: Up to 8 weeks
Reported and Intended Behaviour Scale (RIBS). The scale was adapted by asking about future intentions to live with, have friendships with or let children interact with people with mental health problems, homelessness or intellectual disabilities. Responses consisted of Likert-type items (1 strongly agree, 5 strongly disagree). Higher scores are indicative of better future behaviour.
Attitudes towards mental disorders
Time frame: Up to 8 weeks
Attributional Questionnaire-9 (AQ-9). It is a reduced version of the Attribution Questionnaire-27, consisting of 9 items instead of 27. The questionnaire includes 9 items in Likert-type format with 9 response alternatives ranging from "1 = not at all" to "9 = very much".
Attitudes towards disability
Time frame: Up to 8 weeks
Attitudes to Disability Scale (ADS): This scale is one of the most complete scales for assessing stigma towards intellectual disability. It was developed as part of an international World Health Organization study, in which Spain participated alongside other countries. The scale consists of 16 Likert-type items (1 = strongly agree and 5 = strongly disagree). These items are gathered in 4 subscales: Inclusion-exclusion, Discrimination, Gains and Hopes. It has adequate psychometric properties.
Attitudes towards homelessness
Time frame: Up to 8 weeks
Survey attitudes towards Homeless People: This scale consists of 9 Likert-type items (1 = strongly agree and 6 = strongly disagree). It explores various attitudes towards homeless people (people sleeping on the streets or in shelters). It has good psychometric properties.
Disclosure about mental disorders
Time frame: Up to 8 weeks
This scale assess opinions and attitudes towards disclosure of mental health problems, as well as the ability to talk about them and to identify the main agents and sources of support for people, through this question: "If a close person (family member, friend, partner) had a mental health problem...? ". Questions are rated on a 5 Likert-type scale, where 1 = I would definitely talk about it with them, and 5 = I would avoid talking about it with them.
Key aspects of stigma
Time frame: Up to 8 weeks
In addition to the standardized instruments, a number of selected questions on key aspects of stigma are included in the survey. These qualitative aspects were highlighted by people with mental illness, people experiencing homelessness, and people with intellectual disabilities who participated in a series of focus groups. Questions are rated on a 5 Likert-type scale (1 = strongly disagree and 5 = strongly agree)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Muñoz, Ph.D. study chair
Universidad Complutense de Madrid
Manuel Muñoz, Ph.D. principal investigator
Universidad Complutense de Madrid
Questions about this trial
What is this clinical trial studying?
An observational study of General Population, run by Universidad Complutense de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Muñoz, Ph.D. (0034913943129, mmunozlo@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social distance desire (time frame: Up to 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.