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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Austria1 site
  • Medical University Innsbruck

    Innsbruck, 6020

Other trials in Austria

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.

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 groups in NCT01998516
Study groupRoleWhat they receive
Schizophrenia PatientsNot described
Bipolar I PatientsNot described
Siblings of Schizophrenia PatientsNot described
Siblings of Bipolar I PatientsNot described
Healthy ControlsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emotional Intelligence

    Assessed with the MSCEIT (Mayer-Salovey-Caruso-Emotional-Intelligence-Test

    Measured: 24 month

Secondary outcomes (1)
  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.

  1. First posted29 Nov 2013 (estimated)
  2. Study startDec 2013
  3. Primary completion31 Dec 2016
  4. Study completion31 Jul 2017

Resources

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)
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

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.

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