- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05742893
Comparison of a Speech-Language Assessment Tool for Pragmatic and Discourse Skills in Schizophrenia Spectrum Disorders (VEOS)
Comparison of a Speech-Language Pathology Assessment Tool for Pragmatic and Discourse Skills for Patients With Schizophrenic Spectrum Disorders and Other Psychotic Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The scientific literature has largely objectified language disorders in schizophrenia. And more precisely, the impairment of pragmatic and discursive language skills. Currently, there is no standardized language assessment tool specific to these patients. The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia.
To do so, patients will have to pass six tests: three tests of the new tool and three corresponding gold standard tests. The first two tests will assess pragmatic skills by means of a semi-directed interview. The next two tests will assess discourse skills through two image description tasks. Finally, the last two tests will evaluate narrative skills through the oral restitution of two heard texts.
The main objective is to compare the performance of schizophrenic patients detected in the pathological zone with the scales of the new tool versus the gold standard scales.
The secondary objective is to determine which skills are most affected by comparing patients' scores in pragmatic skills versus those in discourse skills.
This tool would allow to precisely objectify language disorders and to optimize the multidisciplinary diagnosis and care of patients suffering from schizophrenia.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nice, France, 06003
- CHU de Nice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female between the ages of 18 and 60
- Patient with a diagnosis of schizophrenic spectrum disorder and other psychotic disorders meeting DSM V criteria
- Patient who has been clinically and treatment stable for at least three months
- Patient who can read and write French
- Patient who is a beneficiary of a social security plan or similar
- Patient with ability to sign free and informed consent
Exclusion Criteria:
- - Patient hospitalized under restraint
- Patient under guardianship
- Patient who has stopped taking his or her treatment
- Patient who had a change in treatment in the period of less than three months prior to the pass
- Patient with a worsening of the disease in the three months prior to the inclusion visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: diagnostic
all patients have the study test
|
The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assess of pragmatic skills
Time Frame: day 0
|
The patients is evaluated by means of a semi-directed interview
|
day 0
|
|
assess discourse skills
Time Frame: day 0
|
he patient is evaluated through two image description tasks
|
day 0
|
|
assess narrative skills
Time Frame: day 0
|
the patients is evaluated through the oral restitution of two heard texts.
|
day 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: Benoit Michel, Centre Hospitalier Universitaire de Nice
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-AOI-04
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.
Clinical Trials on Psychotic Disorders
-
Medical College of WisconsinCompletedSchizophrenia | Affective Disorders | Psychotic Disorder | Psychotic Mood Disorder
-
Instituto de Investigación Hospital Universitario...Carlos III Health Institute; European Regional Development FundCompletedSchizophrenia and Disorders With Psychotic Features | Psychotic EpisodeSpain
-
Centre hospitalier de Ville-Evrard, FranceRecruiting
-
Søren Dinesen ØstergaardCompletedAffective Disorders, PsychoticDenmark
-
University Hospital, Strasbourg, FranceRecruiting
-
University of California, San DiegoCompletedSchizophrenia | Schizoaffective Disorder | Mood Disorder, PsychoticUnited States
-
Instituto de Investigación Hospital Universitario...CompletedSchizophrenia and Disorders With Psychotic Feature | Psychotic EpisodeSpain
-
Boston Medical CenterNational Institute of Mental Health (NIMH); Beth Israel Deaconess Medical CenterCompletedPsychotic Disorders | Psychosis | Psychotic EpisodeUnited States
-
University of MinnesotaUniversity of California, San FranciscoCompletedPsychotic Disorders | Schizophrenia | Schizoaffective Disorder | Cognitive Impairment | Psychosis | Treatment | Psychotic Depression | Psychotic Episode | Active Control | Psychotic Mood DisordersUnited States
-
Natalia Dewi Wardani, MDIndonesian Red Cross; The Indonesian Red CrossCompleted
Clinical Trials on Measurement of pragmatic and discourse test scores in the two scales.
-
Nigde Omer Halisdemir UniversityCompletedSensory Processing Disorder | Infant Development | PacifierTurkey
-
Universidade da CoruñaRecruitingLigament Rupture | Ligament Injury | Ligament DisordersPortugal
-
Gazi UniversityCompletedMotor Development | Congenital Muscular Torticollis | Sensory Integration DisorderTurkey
-
Gazi UniversityCompleted
-
University Hospital, AngersUnknownAmputation | Lower Extremity
-
IRCCS San RaffaeleRecruitingInfertility | Male InfertilityItaly
-
Guy's and St Thomas' NHS Foundation TrustKing's College LondonRecruiting
-
Hacettepe UniversityNot yet recruitingSports Physical TherapyTurkey
-
Centre Hospitalier Universitaire de NīmesCompletedBlood Pressure Disorders | Pregnancy Induced HypertensionFrance
-
University of Sao Paulo General HospitalUnknownMetabolic Diseases | Osteoarthritis