- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03225027
Study on Communication Comprehension in the Schizophrenic Spectrum (SKYPROVERB)
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Emotional judgment task
- Behavioral: Post-experimental questionnaire
- Behavioral: Recognition task
- Behavioral: Detection task
- Other: CAPE-42
- Diagnostic test: Trait Emotional Intelligence Questionnaire
- Diagnostic test: Positive And Negative Syndrome Scale
- Other: Mini International Neuropsychiatric Interview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cergy-Pontoise, France, 95303
- HDJ François Villon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having a diagnosis of schizophrenia and being in a stable phase of the disease
- Having between 18 to 60 years old
- Speak french or using french at school
- Accepting not to use psychoactive substances during the preceding 48h
- Being affiliated to the French social security
- Providing their written informed consent
Non-inclusion Criteria:
- Having not audio deficits, nor visual uncorrected deficits
- Having not suffering from depressive symptoms during the last 6 months
Exclusion Criteria:
- Having no neurological, nor psychiatric disease except schizophrenia for the patients groups.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with schizophrenia
Emotional judgment task, post-experimental questionnaire, recognition task, detection task, questionnaire CAPE-42, trait emotional intelligence questionnaire and positive and negative syndrome scale.
|
Participants had to indicate on a computer the emotional intensity of audio recordings.
Participants will be invited to give us the cognitive strategy used to resolve the emotional judgment task.
Participants will be invited to indicate which recordings they had heard during the emotional judgment task to verify that they have paid attention to the emotional task.
Participants indicate every time they heard a given sound in order to verify their audition level.
This questionnaire allows evaluating the nature of psychotic experiences.
To evaluate their emotional intelligence.
Other Names:
Evaluating the clinical status of patients with schizophrenia.
Other Names:
|
Experimental: Few psychotic experiences
Healthy participants with few psychotic experience.
Participants with the lowest score to the CAPE-42 test.
Mini International Neuropsychiatric Interview
|
Participants had to indicate on a computer the emotional intensity of audio recordings.
Participants will be invited to give us the cognitive strategy used to resolve the emotional judgment task.
Participants will be invited to indicate which recordings they had heard during the emotional judgment task to verify that they have paid attention to the emotional task.
Participants indicate every time they heard a given sound in order to verify their audition level.
This questionnaire allows evaluating the nature of psychotic experiences.
To evaluate their emotional intelligence.
Other Names:
Evaluating the exclusion criteria in healthy participants.
Other Names:
|
Experimental: Several psychotic experiences
Healthy participants with several psychotic experiences.
Participants with the highest score to the CAPE-42 test.
Mini International Neuropsychiatric Interview
|
Participants had to indicate on a computer the emotional intensity of audio recordings.
Participants will be invited to give us the cognitive strategy used to resolve the emotional judgment task.
Participants will be invited to indicate which recordings they had heard during the emotional judgment task to verify that they have paid attention to the emotional task.
Participants indicate every time they heard a given sound in order to verify their audition level.
This questionnaire allows evaluating the nature of psychotic experiences.
To evaluate their emotional intelligence.
Other Names:
Evaluating the exclusion criteria in healthy participants.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioural measures (response rate and time)
Time Frame: During the experiment
|
Participants will have to judge the emotional intensity of audio recordings. In this task, the participant is asked to judge the emotional intensity of audio recordings of men and women (2 actors + 2 actresses): he / she must press a button as quickly as possible to indicate whether the Audio recordings presented via small speakers are very negative, negative, non-emotional, positive or very positive (5 possible choices). The response time variable may be added as a co-variable in order to avoid perceptive-motor disorders (medication-related and / or general motor slowdown) that may influence the results of time-of- answers. |
During the experiment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptomatic impact
Time Frame: During the experiment
|
Evaluate the nature of the psychotic experiments (CAPE-42 test).
|
During the experiment
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Evaluate the cognitive functioning
Time Frame: During the experiment
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Neuropsychological tests will allow evaluating the cognitive profile of the participants that can impact their behaviour during the experiment.
|
During the experiment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mouna TRABELSI, MD, HDJ François Villon (Centre Hospitaliser René-Dubos)
- Study Chair: Virginie BEAUCOUSIN, PhD, CRFDP (University of Rouen)
Publications and helpful links
General Publications
- Brazo P, Beaucousin V, Lecardeur L, Razafimandimby A, Dollfus S. Social cognition in schizophrenic patients: the effect of semantic content and emotional prosody in the comprehension of emotional discourse. Front Psychiatry. 2014 Sep 10;5:120. doi: 10.3389/fpsyt.2014.00120. eCollection 2014.
- Edwards J, Jackson HJ, Pattison PE. Emotion recognition via facial expression and affective prosody in schizophrenia: a methodological review. Clin Psychol Rev. 2002 Jul;22(6):789-832. doi: 10.1016/s0272-7358(02)00130-7. Erratum In: Clin Psychol Rev. 2002 Nov;22(8):1267-85.
- Beaucousin V, Lacheret A, Turbelin MR, Morel M, Mazoyer B, Tzourio-Mazoyer N. FMRI study of emotional speech comprehension. Cereb Cortex. 2007 Feb;17(2):339-52. doi: 10.1093/cercor/bhj151. Epub 2006 Mar 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRD0814
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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