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Study on Communication Comprehension in the Schizophrenic Spectrum (SKYPROVERB)

Primary Purpose

Schizophrenia Simple

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Emotional judgment task
Post-experimental questionnaire
Recognition task
Detection task
CAPE-42
Trait Emotional Intelligence Questionnaire
Positive And Negative Syndrome Scale
Mini International Neuropsychiatric Interview
Sponsored by
Hôpital NOVO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia Simple focused on measuring Emotional prosody, schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • HDJ François Villon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patients with schizophrenia

Few psychotic experiences

Several psychotic experiences

Arm Description

Emotional judgment task, post-experimental questionnaire, recognition task, detection task, questionnaire CAPE-42, trait emotional intelligence questionnaire and positive and negative syndrome scale.

Healthy participants with few psychotic experience. Participants with the lowest score to the CAPE-42 test. Mini International Neuropsychiatric Interview

Healthy participants with several psychotic experiences. Participants with the highest score to the CAPE-42 test. Mini International Neuropsychiatric Interview

Outcomes

Primary Outcome Measures

Behavioural measures (response rate and time)
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.

Secondary Outcome Measures

Symptomatic impact
Evaluate the nature of the psychotic experiments (CAPE-42 test).
Evaluate the cognitive functioning
Neuropsychological tests will allow evaluating the cognitive profile of the participants that can impact their behaviour during the experiment.

Full Information

First Posted
July 17, 2017
Last Updated
July 26, 2019
Sponsor
Hôpital NOVO
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1. Study Identification

Unique Protocol Identification Number
NCT03225027
Brief Title
Study on Communication Comprehension in the Schizophrenic Spectrum
Acronym
SKYPROVERB
Official Title
Study on Communication Comprehension in the Schizophrenic Spectrum
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
May 27, 2019 (Actual)
Study Completion Date
May 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital NOVO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the present study is to evaluate the effect of emotional prosody on the perception of emotional discourse in the schizophrenic spectrum. The investigators hypothesize that participant may use emotional prosody as an emotional cue to understand the emotional content of discourse.
Detailed Description
The integration of ortholinguistic and paralinguistic functions in language, particularly of the emotional prosody, is necessary to interact adaptively with others. People in the schizophrenic spectrum have social difficulties. Is emotional prosody comprehension altered in these people? According to Edwards et al. (2002), there is methodological issues concerning the tasks used to answer this question. Investigators built an emotional judgment task more adapted to study the perception of emotional prosody in the schizophrenic spectrum than the classical paradigm designed to evaluate participants with cerebral injury. The investigators have elaborated a material that consists of 140 short sentences (7±2 words) with a simple syntactic structure. The verbal content expressed positive, neutral or negative emotions. These sentences were announced by four professional actors (two female) with an emotional prosody content congruent or inconsistent with the verbal content. Participants will have to evaluate the emotional intensity of the recordings on a five points Likert scale, from strongly negative to strongly positive. Psychotic experiences of all participants will be evaluated too.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Simple
Keywords
Emotional prosody, schizophrenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One experimental procedure proposed to three groups of participants
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with schizophrenia
Arm Type
Experimental
Arm Description
Emotional judgment task, post-experimental questionnaire, recognition task, detection task, questionnaire CAPE-42, trait emotional intelligence questionnaire and positive and negative syndrome scale.
Arm Title
Few psychotic experiences
Arm Type
Experimental
Arm Description
Healthy participants with few psychotic experience. Participants with the lowest score to the CAPE-42 test. Mini International Neuropsychiatric Interview
Arm Title
Several psychotic experiences
Arm Type
Experimental
Arm Description
Healthy participants with several psychotic experiences. Participants with the highest score to the CAPE-42 test. Mini International Neuropsychiatric Interview
Intervention Type
Behavioral
Intervention Name(s)
Emotional judgment task
Intervention Description
Participants had to indicate on a computer the emotional intensity of audio recordings.
Intervention Type
Behavioral
Intervention Name(s)
Post-experimental questionnaire
Intervention Description
Participants will be invited to give us the cognitive strategy used to resolve the emotional judgment task.
Intervention Type
Behavioral
Intervention Name(s)
Recognition task
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Detection task
Intervention Description
Participants indicate every time they heard a given sound in order to verify their audition level.
Intervention Type
Other
Intervention Name(s)
CAPE-42
Intervention Description
This questionnaire allows evaluating the nature of psychotic experiences.
Intervention Type
Diagnostic Test
Intervention Name(s)
Trait Emotional Intelligence Questionnaire
Other Intervention Name(s)
TEIQUE
Intervention Description
To evaluate their emotional intelligence.
Intervention Type
Diagnostic Test
Intervention Name(s)
Positive And Negative Syndrome Scale
Other Intervention Name(s)
PANSS
Intervention Description
Evaluating the clinical status of patients with schizophrenia.
Intervention Type
Other
Intervention Name(s)
Mini International Neuropsychiatric Interview
Other Intervention Name(s)
MINI
Intervention Description
Evaluating the exclusion criteria in healthy participants.
Primary Outcome Measure Information:
Title
Behavioural measures (response rate and time)
Description
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.
Time Frame
During the experiment
Secondary Outcome Measure Information:
Title
Symptomatic impact
Description
Evaluate the nature of the psychotic experiments (CAPE-42 test).
Time Frame
During the experiment
Title
Evaluate the cognitive functioning
Description
Neuropsychological tests will allow evaluating the cognitive profile of the participants that can impact their behaviour during the experiment.
Time Frame
During the experiment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mouna TRABELSI, MD
Organizational Affiliation
HDJ François Villon (Centre Hospitaliser René-Dubos)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Virginie BEAUCOUSIN, PhD
Organizational Affiliation
CRFDP (University of Rouen)
Official's Role
Study Chair
Facility Information:
Facility Name
HDJ François Villon
City
Cergy-Pontoise
ZIP/Postal Code
95303
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25309458
Citation
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.
Results Reference
result
PubMed Identifier
12214327
Citation
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.
Results Reference
result
PubMed Identifier
16525130
Citation
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.
Results Reference
result

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Study on Communication Comprehension in the Schizophrenic Spectrum

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