Study on Communication Comprehension in the Schizophrenic Spectrum (SKYPROVERB)

July 26, 2019 updated by: Centre Hospitalier René Dubos
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cergy-Pontoise, France, 95303
        • HDJ François Villon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • TEIQUE
Evaluating the clinical status of patients with schizophrenia.
Other Names:
  • PANSS
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:
  • TEIQUE
Evaluating the exclusion criteria in healthy participants.
Other Names:
  • MINI
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:
  • TEIQUE
Evaluating the exclusion criteria in healthy participants.
Other Names:
  • MINI

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
Evaluate the cognitive functioning
Time Frame: During the experiment
Neuropsychological tests will allow evaluating the cognitive profile of the participants that can impact their behaviour during the experiment.
During the experiment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2016

Primary Completion (Actual)

May 27, 2019

Study Completion (Actual)

May 27, 2019

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CHRD0814

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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