Schizophrenia SimpleSKYPROVERBNCT03225027
Study on Communication Comprehension in the Schizophrenic Spectrum
A study testing Emotional judgment task, Post-experimental questionnaire and Recognition task in people with Schizophrenia Simple, run by Hôpital NOVO at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Simple
- What is being tested?
- Emotional judgment task, Post-experimental questionnaire and Recognition task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2016to 27 May 2019
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- Non-inclusion Criteria:
- Having not audio deficits, nor visual uncorrected deficits
- Having not suffering from depressive symptoms during the last 6 months
Who cannot join
- Having no neurological, nor psychiatric disease except schizophrenia for the patients groups.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Schizophrenia Simple
- Being tested
- Emotional judgment task, Post-experimental questionnaire, Recognition task, Detection task, CAPE-42
- Keywords
- Emotional prosody, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional judgment taskBehavioural
Participants had to indicate on a computer the emotional intensity of audio recordings.
Post-experimental questionnaireBehavioural
Participants will be invited to give us the cognitive strategy used to resolve the emotional judgment task.
Recognition taskBehavioural
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.
Detection taskBehavioural
Participants indicate every time they heard a given sound in order to verify their audition level.
CAPE-42Other
This questionnaire allows evaluating the nature of psychotic experiences.
Trait Emotional Intelligence QuestionnaireDiagnostic test
Also called TEIQUE
To evaluate their emotional intelligence.
Positive And Negative Syndrome ScaleDiagnostic test
Also called PANSS
Evaluating the clinical status of patients with schizophrenia.
Mini International Neuropsychiatric InterviewOther
Also called MINI
Evaluating the exclusion criteria in healthy participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
| Few psychotic experiences | Experimental | Healthy participants with few psychotic experience. Participants with the lowest score to the CAPE-42 test. Mini International Neuropsychiatric Interview Receives: Behavioral: Emotional judgment task; Behavioral: Post-experimental questionnaire; Behavioral: Recognition task; Behavioral: Detection task; Other: CAPE-42; Diagnostic Test: Trait Emotional Intelligence Questionnaire; Other: 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 Receives: Behavioral: Emotional judgment task; Behavioral: Post-experimental questionnaire; Behavioral: Recognition task; Behavioral: Detection task; Other: CAPE-42; Diagnostic Test: Trait Emotional Intelligence Questionnaire; Other: Mini International Neuropsychiatric Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the experiment
Secondary outcomes (2)
Symptomatic impact
Evaluate the nature of the psychotic experiments (CAPE-42 test).
Measured: During the experiment
Evaluate the cognitive functioning
Neuropsychological tests will allow evaluating the cognitive profile of the participants that can impact their behaviour during the experiment.
Measured: During the experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start15 Nov 2016
- Primary completion27 May 2019
- Study completion27 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia SimpleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One experimental procedure proposed to three groups of participants
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouna TRABELSI, MD, Principal investigator, HDJ François Villon (Centre Hospitaliser René-Dubos)Virginie BEAUCOUSIN, PhD, Study chair, CRFDP (University of Rouen)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225027
- Sponsor's protocol ID
- CHRD0814
- Acronym
- SKYPROVERB
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2017
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25309458Edwards 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.
PubMed 12214327Beaucousin 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.
PubMed 16525130
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Communication Comprehension in the Schizophrenic Spectrum
- ClinicalTrials.gov ID
- NCT03225027
- Acronym / sponsor ID
- SKYPROVERB / CHRD0814
- Conditions
- Schizophrenia Simple
- Keywords
- Emotional prosody, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 27 May 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- One experimental procedure proposed to three groups of participants
| Arm | Type | Receives |
|---|---|---|
| Patients with schizophrenia | Experimental | 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 ScaleEmotional judgment task, post-experimental questionnaire, recognition task, detection task, questionnaire CAPE-42, trait emotional intelligence questionnaire and positive and negative syndrome scale. |
| Few psychotic experiences | Experimental | Behavioral: Emotional judgment task, Behavioral: Post-experimental questionnaire, Behavioral: Recognition task, Behavioral: Detection task, Other: CAPE-42, Diagnostic Test: Trait Emotional Intelligence Questionnaire, Other: Mini International Neuropsychiatric InterviewHealthy participants with few psychotic experience. Participants with the lowest score to the CAPE-42 test. Mini International Neuropsychiatric Interview |
| Several psychotic experiences | Experimental | Behavioral: Emotional judgment task, Behavioral: Post-experimental questionnaire, Behavioral: Recognition task, Behavioral: Detection task, Other: CAPE-42, Diagnostic Test: Trait Emotional Intelligence Questionnaire, Other: Mini International Neuropsychiatric InterviewHealthy participants with several psychotic experiences. Participants with the highest score to the CAPE-42 test. Mini International Neuropsychiatric Interview |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Having no neurological, nor psychiatric disease except schizophrenia for the patients groups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional judgment taskParticipants had to indicate on a computer the emotional intensity of audio recordings. | Behavioural | Few psychotic experiences, Patients with schizophrenia, Several psychotic experiences |
| Post-experimental questionnaireParticipants will be invited to give us the cognitive strategy used to resolve the emotional judgment task. | Behavioural | Few psychotic experiences, Patients with schizophrenia, Several psychotic experiences |
| Recognition taskParticipants 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. | Behavioural | Few psychotic experiences, Patients with schizophrenia, Several psychotic experiences |
| Detection taskParticipants indicate every time they heard a given sound in order to verify their audition level. | Behavioural | Few psychotic experiences, Patients with schizophrenia, Several psychotic experiences |
| CAPE-42This questionnaire allows evaluating the nature of psychotic experiences. | Other | Few psychotic experiences, Patients with schizophrenia, Several psychotic experiences |
| Trait Emotional Intelligence QuestionnaireAlso: TEIQUETo evaluate their emotional intelligence. | Diagnostic test | Few psychotic experiences, Patients with schizophrenia, Several psychotic experiences |
| Positive And Negative Syndrome ScaleAlso: PANSSEvaluating the clinical status of patients with schizophrenia. | Diagnostic test | Patients with schizophrenia |
| Mini International Neuropsychiatric InterviewAlso: MINIEvaluating the exclusion criteria in healthy participants. | Other | Few psychotic experiences, Several psychotic experiences |
Primary outcome
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.
2 secondary outcomes
Symptomatic impact
Time frame: During the experiment
Evaluate the cognitive functioning
Time frame: During the experiment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Results publication: PubMed 25309458Brazo 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 publication: PubMed 12214327Edwards 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.
- Results publication: PubMed 16525130Beaucousin 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mouna TRABELSI, MD principal investigator
HDJ François Villon (Centre Hospitaliser René-Dubos)
Virginie BEAUCOUSIN, PhD study chair
CRFDP (University of Rouen)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional judgment task, Post-experimental questionnaire and Recognition task in people with Schizophrenia Simple, run by Hôpital NOVO at 1 site in France.
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 9 inclusion and 1 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 29 Jul 2019. 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 France. 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?
Behavioural measures (response rate and time) (time frame: During the experiment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03225027, which also lists 3 linked publications.
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 29 Jul 2019.