NCT03225027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2019

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

July 17, 2017

Last Update Submit

July 26, 2019

Conditions

Keywords

Emotional prosody, schizophrenia

Outcome Measures

Primary Outcomes (1)

  • 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.

    During the experiment

Secondary Outcomes (2)

  • Symptomatic impact

    During the experiment

  • Evaluate the cognitive functioning

    During the experiment

Study Arms (3)

Patients with schizophrenia

EXPERIMENTAL

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

Behavioral: Emotional judgment taskBehavioral: Post-experimental questionnaireBehavioral: Recognition taskBehavioral: Detection taskOther: CAPE-42Diagnostic Test: Trait Emotional Intelligence QuestionnaireDiagnostic Test: Positive And Negative Syndrome Scale

Few psychotic experiences

EXPERIMENTAL

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

Behavioral: Emotional judgment taskBehavioral: Post-experimental questionnaireBehavioral: Recognition taskBehavioral: Detection taskOther: CAPE-42Diagnostic Test: Trait Emotional Intelligence QuestionnaireOther: Mini International Neuropsychiatric Interview

Several psychotic experiences

EXPERIMENTAL

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

Behavioral: Emotional judgment taskBehavioral: Post-experimental questionnaireBehavioral: Recognition taskBehavioral: Detection taskOther: CAPE-42Diagnostic Test: Trait Emotional Intelligence QuestionnaireOther: Mini International Neuropsychiatric Interview

Interventions

Participants had to indicate on a computer the emotional intensity of audio recordings.

Few psychotic experiencesPatients with schizophreniaSeveral psychotic experiences

Participants will be invited to give us the cognitive strategy used to resolve the emotional judgment task.

Few psychotic experiencesPatients with schizophreniaSeveral psychotic experiences

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.

Few psychotic experiencesPatients with schizophreniaSeveral psychotic experiences
Detection taskBEHAVIORAL

Participants indicate every time they heard a given sound in order to verify their audition level.

Few psychotic experiencesPatients with schizophreniaSeveral psychotic experiences
CAPE-42OTHER

This questionnaire allows evaluating the nature of psychotic experiences.

Few psychotic experiencesPatients with schizophreniaSeveral psychotic experiences

To evaluate their emotional intelligence.

Also known as: TEIQUE
Few psychotic experiencesPatients with schizophreniaSeveral psychotic experiences

Evaluating the clinical status of patients with schizophrenia.

Also known as: PANSS
Patients with schizophrenia

Evaluating the exclusion criteria in healthy participants.

Also known as: MINI
Few psychotic experiencesSeveral psychotic experiences

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Having not audio deficits, nor visual uncorrected deficits
  • Having not suffering from depressive symptoms during the last 6 months

You may not qualify if:

  • \- Having no neurological, nor psychiatric disease except schizophrenia for the patients groups.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HDJ François Villon

Cergy-Pontoise, 95303, France

Location

Related Publications (3)

  • 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.

  • 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.

MeSH Terms

Conditions

Schizophrenia

Interventions

Gene ExpressionPsychiatric Status Rating Scales

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Genetic PhenomenaNeuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Mouna TRABELSI, MD

    HDJ François Villon (Centre Hospitaliser René-Dubos)

    PRINCIPAL INVESTIGATOR
  • Virginie BEAUCOUSIN, PhD

    CRFDP (University of Rouen)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: One experimental procedure proposed to three groups of participants
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 21, 2017

Study Start

November 15, 2016

Primary Completion

May 27, 2019

Study Completion

May 27, 2019

Last Updated

July 29, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations