SchizophreniaNCT01998516
Emotional Intelligence in Schizophrenia and Bipolar-I- Disorder
An observational study of Schizophrenia and Bipolar I Disorder, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Scientific Background Emotional Intelligence (EI) as a part of social cognition is a rather new area of interest which focuses on personality traits and abilities enabling people to cope with both their own feelings as well as those of others. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar I Disorder
- How many people
- 350 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2013to 31 Jul 2017
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Psychiatric out- and inpatient setting
Who may be able to join
- ICD-10 diagnosis of schizophrenia or BD (verified by Mini International Neuropsychiatric Interview (M.I.N.I.)
- Outpatients with stable psychopathology for at least half a year and fixed treatment regimen for at least one month prior to testing
- Age: 18-65 years
- Native German Speakers
- Written informed consent
Who cannot join
- Other axis 1 disorder (verified by M.I.N.I.)
- History of organic mental disorder
- Mental Retardation
- Epilepsy
- Pregnancy/breast-feeding
- Unstable and/or severe organ system diseases, e.g. cardiovascular, endocrine, metabolic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotional Intelligence in Schizophrenia and Bipolar I Disorder: a Comparison Between Patients, Their Siblings, and Healthy Controls
Scientific Background
Emotional Intelligence (EI) as a part of social cognition is a rather new area of interest which focuses on personality traits and abilities enabling people to cope with both their own feelings as well as those of others. The "Mayer-Salovey-Caruso-Emotional-Intelligence-Test" (MSCEIT) (1) represents a valid and reliable instrument which exclusively covers the emotional components of social cognition. Recent findings indicate, that social cognitive impairments are useful vulnerability indicators and that EI could be an endophenotype for schizophrenia and bipolar I disorder (BD I). To confirm the endophenotype theory, studies concerning EI in relatives of schizophrenia and bipolar patients are needed. To date, studies on EI in BD patients as well as in first degree relatives of patients with schizophrenia or BD haven't been conducted yet. Accordingly, the current study focuses on the four categories assessed by the MSCEIT and aims to compare the task performance of patients, their first degree relatives and healthy control subjects. We assume that the task performance of relatives lies between that of patients and controls. The confirmation of this assumption would verify the trait marker hypothesis and could be a next step to identify a heritable endophenotype for schizophrenia and BD.
Read more
Hypotheses
Compared to healthy control subjects patients suffering from schizophrenia or BD I show deficits in EI. Siblings of patients with schizophrenia or BD I show deficits in EI and their task performance lies between that of patients and healthy controls. Deficits in EI are more pronounced in schizophrenia patients than in patients with BD I and are more pronounced in siblings of schizophrenia patients than in siblings of patients with BD I. Independently of diagnosis, deficits in EI affect patients' functional and subjective outcomes.
Methods
Emotional Intelligence will be examined using the MSCEIT in patients with schizophrenia, siblings of schizophrenia patients, patients with BD I, siblings of BD I patients and healthy volunteers matched for age, sex, and educational level. Structured clinical interviews according to DSM-IV (M.I.N.I. + SCID II) will be carried out to assure the diagnosis of schizophrenia or bipolar disorder as well as to detect (comorbid) Axis I and Axis II psychiatric disorders (patients, siblings, control subjects). Functional outcome will be assessed by using the GAF (Global Assessment of Functioning Scale) and the PSP (Personal and Social Performance Scale), subjective quality of life will be examined using the BELP (Berliner Lebensqualiätsprofil). The MWT-B (Multiple choice vocabulary test) will be used to assess premorbid intelligence.
- Conditions
- Schizophrenia, Bipolar I Disorder
- Keywords
- Emotional Intelligence
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia Patients | Not described | |
| Bipolar I Patients | Not described | |
| Siblings of Schizophrenia Patients | Not described | |
| Siblings of Bipolar I Patients | Not described | |
| Healthy Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Intelligence
Assessed with the MSCEIT (Mayer-Salovey-Caruso-Emotional-Intelligence-Test
Measured: 24 month
Secondary outcomes (1)
Quality of Life
Assessed with the Lancashire Quality of Life Profile
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2013 (estimated)
- Study startDec 2013
- Primary completion31 Dec 2016
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Paracelsus Medical University, Austrian Science Fund (FWF)
- Responsible party
- Principal investigator, Assoc. Prof. Dr. Alex Hofer, Medical University Innsbruck
- Investigators
- Alex Hofer, Assoc. Prof. Dr., Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998516
- Sponsor's protocol ID
- KLI 366
- Status last verified
- Sep 2017
- First submitted
- 12 Nov 2013
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Intelligence in Schizophrenia and Bipolar I Disorder: a Comparison Between Patients, Their Siblings, and Healthy Controls
- ClinicalTrials.gov ID
- NCT01998516
- Acronym / sponsor ID
- KLI 366
- Conditions
- Schizophrenia, Bipolar I Disorder
- Keywords
- Emotional Intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Paracelsus Medical University, Austrian Science Fund (FWF)
- Study start
- Dec 2013
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 29 Nov 2013 (estimated)
- 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.
Scientific Background
Emotional Intelligence (EI) as a part of social cognition is a rather new area of interest which focuses on personality traits and abilities enabling people to cope with both their own feelings as well as those of others. The "Mayer-Salovey-Caruso-Emotional-Intelligence-Test" (MSCEIT) (1) represents a valid and reliable instrument which exclusively covers the emotional components of social cognition. Recent findings indicate, that social cognitive impairments are useful vulnerability indicators and that EI could be an endophenotype for schizophrenia and bipolar I disorder (BD I). To confirm the endophenotype theory, studies concerning EI in relatives of schizophrenia and bipolar patients are needed. To date, studies on EI in BD patients as well as in first degree relatives of patients with schizophrenia or BD haven't been conducted yet. Accordingly, the current study focuses on the four categories assessed by the MSCEIT and aims to compare the task performance of patients, their first degree relatives and healthy control subjects. We assume that the task performance of relatives lies between that of patients and controls. The confirmation of this assumption would verify the trait marker hypothesis and could be a next step to identify a heritable endophenotype for schizophrenia and BD.
Hypotheses
Compared to healthy control subjects patients suffering from schizophrenia or BD I show deficits in EI. Siblings of patients with schizophrenia or BD I show deficits in EI and their task performance lies between that of patients and healthy controls. Deficits in EI are more pronounced in schizophrenia patients than in patients with BD I and are more pronounced in siblings of schizophrenia patients than in siblings of patients with BD I. Independently of diagnosis, deficits in EI affect patients' functional and subjective outcomes.
Methods
Emotional Intelligence will be examined using the MSCEIT in patients with schizophrenia, siblings of schizophrenia patients, patients with BD I, siblings of BD I patients and healthy volunteers matched for age, sex, and educational level. Structured clinical interviews according to DSM-IV (M.I.N.I. + SCID II) will be carried out to assure the diagnosis of schizophrenia or bipolar disorder as well as to detect (comorbid) Axis I and Axis II psychiatric disorders (patients, siblings, control subjects). Functional outcome will be assessed by using the GAF (Global Assessment of Functioning Scale) and the PSP (Personal and Social Performance Scale), subjective quality of life will be examined using the BELP (Berliner Lebensqualiätsprofil). The MWT-B (Multiple choice vocabulary test) will be used to assess premorbid intelligence.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia Patients | – | – |
| Bipolar I Patients | – | – |
| Siblings of Schizophrenia Patients | – | – |
| Siblings of Bipolar I Patients | – | – |
| Healthy Controls | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatric out- and inpatient setting
Key inclusion criteria (5 listed)
- ICD-10 diagnosis of schizophrenia or BD (verified by Mini International Neuropsychiatric Interview (M.I.N.I.)
- Outpatients with stable psychopathology for at least half a year and fixed treatment regimen for at least one month prior to testing
- Age: 18-65 years
- Native German Speakers
- Written informed consent
Key exclusion criteria (6 listed)
- Other axis 1 disorder (verified by M.I.N.I.)
- History of organic mental disorder
- Mental Retardation
- Epilepsy
- Pregnancy/breast-feeding
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
Emotional Intelligence
Time frame: 24 month
Assessed with the MSCEIT (Mayer-Salovey-Caruso-Emotional-Intelligence-Test
1 secondary outcome
Quality of Life
Time frame: 24 month
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 20 Sep 2017.
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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.
Alex Hofer, Assoc. Prof. Dr. principal investigator
Medical University Innsbruck
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 Schizophrenia and Bipolar I Disorder, run by Medical University Innsbruck at 1 site in Austria.
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 5 inclusion and 6 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 20 Sep 2017. 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 Austria. 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?
Emotional Intelligence (time frame: 24 month). 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 20 Sep 2017.