Bipolar DisorderNCT04304417
The Role of Group Identity on the Community Integration of People With Severe Mental Disorder
An observational study of Bipolar Disorder and Personality Disorders, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
This study analyzes which variables enhance or hinder community integration among people with severe mental disorder. Participants will complete a questionnaire to test our hypotheses: Hypothesis 1: group identification predicts less self-dehumanization and self-stigma, and more empowerment, these in turn predict more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Personality Disorders, Psychotic Disorders
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2020to 1 Apr 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
- No healthy volunteers
- Adult, Older adult
Study population: The population of the study are adult people with a diagnosis of severe mental disorder (SMD), who are users of the public centers of social care for people with SMD of the State of Madrid in Spain.
Who may be able to join
- Having a diagnosis of severe mental disorder.
- Having disorder consciousness.
Who cannot join
- Being underage.
- Being legally incapacitated.
Trial locations and contacts
1 site in 1 country.
About this study
This study analyzes which variables enhance or hinder community integration among people with severe mental disorder. Participants will complete a questionnaire to test our hypotheses:
- Hypothesis 1: group identification predicts less self-dehumanization and self-stigma, and more empowerment, these in turn predict more community integration.
- Hypothesis 2: the relationship between group identification and self-dehumanization and self-stigma is moderated by group value.
- Hypothesis 3: when group identification is low, group identification predicts higher community integration, but this relationship is mediated by diagnosis concealment.
Read the detailed description
Community integration, which includes physical integration (e.g. participation in activities, as well as use of goods and services in the community in a self-initiated manner), social integration (e.g. quantity and quality of social relationships) and psychological integration (e.g. perception of belongingness to the community), is a necessary element to achieve personal recovery among people with severe mental disorder (SMD).
Group identification, based on Social Identity Theory, emphasizes an individual's definition of who they are in relation to their group membership. When individuals have a strong tendency to define their self-concept in terms of the group they belong to and uphold the values of their group, they are said to have high identification with the group. Group value, on the other hand, refers to the evaluative judgment of one's social group, which reflects the extent to which individuals feel positively or negatively toward their ingroup, and people who have positive perceptions toward their group are more strongly identified with it.
Self-dehumanization is the process by which people dehumanize themselves. This can happen in two ways: when they perceiving themselves as unintelligent, amoral, irrational, wild, etc.; thus perceived as animal-like, it is called animalistic dehumanization; or when they perceive themselves as lacking emotion, warmth, vitality, etc.; perceived as object-like, which is referred to as mechanistic dehumanization.
Self-stigma occurs when people accept the negative stereotypes about their in-group apply to themselves. This has shown to influence the community integration of people with SMD.
Empowerment is understood as the process by which people, organizations and communities acquire control over their own lives. People with SMD who endorsed higher group value were more likely to be involved in educating the public about mental health and helping others with mental disorder, which are considered a behavioral manifestation of empowerment.
In order to test the hypotheses previously mentioned, the users of the public centers of social care for people with SMD of the State of Madrid (Spain) will be contacted. The inclusion criteria are: to have a diagnosis of SMD and disorder consciousness. The exclusion criteria are: to be underage and legally incapacitated. Participants will complete a pencil-and-paper questionnaire, including the measurement of the variables previously mentioned and some socio-demographical questions, in the centers they attend.
The analytical program SPSS.25 (Statistical Package for the Social Sciences) will be used to conduct the appropriate test of hypothesis (correlation, regression, mediation, moderation).
- Conditions
- Bipolar Disorder, Personality Disorders, Psychotic Disorders
- Keywords
- Severe Mental Disorder, Community Integration, Group Identity, Stigma, Dehumanization
- Medical subject headings
- Bipolar Disorder, Personality Disorders, Psychotic Disorders, Mental Disorders, Social Stigma, Dehumanization
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical integration
Self-reported frequency of activities realized outdoors, measured with the subscale 'Leisure and community' from the 'Independent living skills survey'. Each item is scored from 1 (never) to 5 (always).
Measured: 1 day. Measured the day of the study.
Social integration
Self-reported frequency of support available, measured with the Medical Outcome Study Social Support Survey (MOS-SSS). Each item is scored from 1 (never) to 5 (always).
Measured: 1 day. Measured the day of the study.
Psychological integration
Self-reported feeling of belonging to the general community and to the community of people with mental disorder. It is measured with the subscale 'Belonging' from the 'Community Integration Measure'. Each item is scored from 1 (I totally disagree) to 5 (I totally agree).
Measured: 1 day. Measured the day of the study.
Secondary outcomes (5)
Self-dehumanization
Haslam's scale of Human Nature and Human Uniqueness to measure wether participants think different adjectives describe them. Each item is scored from 1 (I am not at all like that) to 7 (I am exactly like that).
Measured: 1 day. Measured the day of the study.
Self-stigma
Self-reported measure of participants' internalized stigma using the 'Internalized Stigma of Mental Illness Inventory-9'. Each item range from 1 (I totally disagree) to 4 (I totally agree).
Measured: 1 day. Measured the day of the study.
Empowerment
Self-reported measure of empowerment using the subscales 'Self-esteem-self-efficacy' and 'Community activism and autonomy' from the empowerment scale developed by Rogers, Chamberlin, Ellison y Crean (1997), and the subscale 'disclosure' developed by King et al. (2007). Items range from 1 (I totally disagree) to 4 (I totally agree).
Measured: 1 day. Measured the day of the study.
Group identity
The subscales 'Interconnection of self with the group' and 'Sense of interdependence' from the team identity scale developed by Heere and James (2007). Items range from 1 (I totally disagree) to 7 (I totally agree).
Measured: 1 day. Measured the day of the study.
Group value
The subscale 'Private evaluation' from the team identity scale developed by Heere and James (2007). Items range from 1 (I totally disagree) to 7 (I totally agree).
Measured: 1 day. Measured the day of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start17 Feb 2020
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Ugidos Gutiérrez, Universidad Complutense de Madrid
- Investigators
- Carolina Ugidos, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304417
- Sponsor's protocol ID
- 2019/20-020
- Status last verified
- May 2022
- First submitted
- 6 Mar 2020
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Group Identity on the Community Integration of People With Severe Mental Disorder
- ClinicalTrials.gov ID
- NCT04304417
- Acronym / sponsor ID
- 2019/20-020
- Conditions
- Bipolar Disorder, Personality Disorders, Psychotic Disorders
- Keywords
- Severe Mental Disorder, Community Integration, Group Identity, Stigma, Dehumanization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 11 Mar 2020 (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 study analyzes which variables enhance or hinder community integration among people with severe mental disorder. Participants will complete a questionnaire to test our hypotheses:
- Hypothesis 1: group identification predicts less self-dehumanization and self-stigma, and more empowerment, these in turn predict more community integration.
- Hypothesis 2: the relationship between group identification and self-dehumanization and self-stigma is moderated by group value.
- Hypothesis 3: when group identification is low, group identification predicts higher community integration, but this relationship is mediated by diagnosis concealment.
Detailed description
Community integration, which includes physical integration (e.g. participation in activities, as well as use of goods and services in the community in a self-initiated manner), social integration (e.g. quantity and quality of social relationships) and psychological integration (e.g. perception of belongingness to the community), is a necessary element to achieve personal recovery among people with severe mental disorder (SMD).
Group identification, based on Social Identity Theory, emphasizes an individual's definition of who they are in relation to their group membership. When individuals have a strong tendency to define their self-concept in terms of the group they belong to and uphold the values of their group, they are said to have high identification with the group. Group value, on the other hand, refers to the evaluative judgment of one's social group, which reflects the extent to which individuals feel positively or negatively toward their ingroup, and people who have positive perceptions toward their group are more strongly identified with it.
Self-dehumanization is the process by which people dehumanize themselves. This can happen in two ways: when they perceiving themselves as unintelligent, amoral, irrational, wild, etc.; thus perceived as animal-like, it is called animalistic dehumanization; or when they perceive themselves as lacking emotion, warmth, vitality, etc.; perceived as object-like, which is referred to as mechanistic dehumanization.
Self-stigma occurs when people accept the negative stereotypes about their in-group apply to themselves. This has shown to influence the community integration of people with SMD.
Empowerment is understood as the process by which people, organizations and communities acquire control over their own lives. People with SMD who endorsed higher group value were more likely to be involved in educating the public about mental health and helping others with mental disorder, which are considered a behavioral manifestation of empowerment.
In order to test the hypotheses previously mentioned, the users of the public centers of social care for people with SMD of the State of Madrid (Spain) will be contacted. The inclusion criteria are: to have a diagnosis of SMD and disorder consciousness. The exclusion criteria are: to be underage and legally incapacitated. Participants will complete a pencil-and-paper questionnaire, including the measurement of the variables previously mentioned and some socio-demographical questions, in the centers they attend.
The analytical program SPSS.25 (Statistical Package for the Social Sciences) will be used to conduct the appropriate test of hypothesis (correlation, regression, mediation, moderation).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study are adult people with a diagnosis of severe mental disorder (SMD), who are users of the public centers of social care for people with SMD of the State of Madrid in Spain.
Key inclusion criteria (2 listed)
- Having a diagnosis of severe mental disorder.
- Having disorder consciousness.
Key exclusion criteria (2 listed)
- Being underage.
- Being legally incapacitated.
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
Physical integration
Time frame: 1 day. Measured the day of the study.
Self-reported frequency of activities realized outdoors, measured with the subscale 'Leisure and community' from the 'Independent living skills survey'. Each item is scored from 1 (never) to 5 (always).
Social integration
Time frame: 1 day. Measured the day of the study.
Self-reported frequency of support available, measured with the Medical Outcome Study Social Support Survey (MOS-SSS). Each item is scored from 1 (never) to 5 (always).
Psychological integration
Time frame: 1 day. Measured the day of the study.
Self-reported feeling of belonging to the general community and to the community of people with mental disorder. It is measured with the subscale 'Belonging' from the 'Community Integration Measure'. Each item is scored from 1 (I totally disagree) to 5 (I totally agree).
5 secondary outcomes
Self-dehumanization
Time frame: 1 day. Measured the day of the study.
Self-stigma
Time frame: 1 day. Measured the day of the study.
Empowerment
Time frame: 1 day. Measured the day of the study.
Group identity
Time frame: 1 day. Measured the day of the study.
Group value
Time frame: 1 day. Measured the day of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
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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.
Carolina Ugidos principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Personality Disorders, run by Universidad Complutense de Madrid at 1 site in Spain.
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 2 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: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical integration (time frame: 1 day. Measured the day of the study.). The study lists 3 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 27 May 2022.