Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis (TDLRipsy)

This research concerns the study of language disorders of patients present in the spectrum of psychosis. It is indeed accepted that psychotic disorders are associated with language difficulties, which are only poorly highlighted thanks to reusable tools in clinical practice. These language disorders impact communication, and concern many linguistic domains, thus covering phonology, lexicon, semantics, morphosyntax and pragmatics. It therefore seems relevant to characterize these language disorders and to assess to what extent they interact with the other symptoms of the pathology, in particular the course of the thought disorder and the neuropsychological symptoms. In addition, this study is particularly interested in the interactions between working memory capacities and those related to syntax. It is intended for different patients suffering from psychotic disorders of different intensities, treated in the Psychotherapeutic Center of Nancy. Patients suffering from at-risk mental state (ARMS), first episode of psychosis (FEP) or schizophrenia will benefit from a complete language assessment, evaluating each domain mentioned above, on the expressive and understanding sides. The results of the language assessment will be compared with those of a control group in the same tests. They will also be analyzed with regard to the neuropsychological and psychiatric elements noted in the patient's medical file, in order to highlight possible associations between language skills, neuropsychological and psychiatric symptoms in this patient population.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Language Disorders; Psychosis; At-risk Mental State
• Intervention / Treatment: Behavioral: Language assessment; Combination product: CAST - Cannabis Abuse Screening Test; Behavioral: TLC - Scale for the Assessment of Thought, Language, and Communication; Behavioral: MINI - Mini International Neuropsychiatric Interview

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anaëlle PAJAUD; Phone Number: 0383260863; Email: Anaelle.PAJAUD@cpn-laxou.com
• Study Contact Backup: Name: Naoual MELLOUKI, PhD; Phone Number: 0383925267; Email: Naoual.MELLOUKIBENDIMRED@cpn-laxou.com

Study Locations

• France
  • Laxou, France, 54520
    • Recruiting
    • Centre Psychothérapeutique de Nancy
    • Contact: Florent M Bernardin; Email: Florent.BERNARDIN@cpn-laxou.com
    • Contact: Anaëlle PAJAUD; Email: Anaelle.PAJAUD@cpn-laxou.com
    • Principal Investigator: Florent BERNARDIN, PhD psy
    • Sub-Investigator: Vincent LAPRÉVOTE, Pr.
    • Sub-Investigator: Anaëlle PAJAUD, PhD Student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All Groups:

  • Patient affiliated or entitled to a social security scheme
  • Patient having received informed information on the study and having co-signed, with the investigator, a consent to participate in the study
  • For minor participants, at least one of the parents or holders of parental authority having been informed of the study, having received the information note relating to it and not having objected to the participation of his or her child
  • Native language: French

• ARMS and FEP Patient Group:

  • Age between 16 and 35 years old
  • Present the criteria for EMRP or FEP as defined by the Comprehensive Assessment of At Risk Mental State (CAARMS) or present the criteria for Disorders of the course of thought to the items of the Schizophrenia Proneness Instrument (SPI-A)

• Patients with schizophrenia group:

  • Age between 16 and 55 years old
  • Patient with diagnostic criteria for schizophrenia, as defined by DSM V (American Psychiatric Association, 2015)
  • Present the criteria for Disorganization of Speech and Formal Thought Disorder as defined by the Thinking, Language and Communication (TLC) Rating Scale.

• Healthy Volunteers Group:

  • Age between 16 and 55 years old
  • Parental authorization (of both parents) to participate in the study for minor patients

Exclusion Criteria:

• All groups:

  • Pregnant, parturient or nursing mother
  • Person deprived of liberty by a judicial or administrative decision
  • Person in a life-threatening emergency
  • Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
  • Adult person unable to express their consent and who is not the subject of a legal protection measure
  • Impairment of the subject making it difficult, if not impossible, for them to participate in the trial or to understand the information given to them
  • Abuse or dependence of any substance according to DSM V criteria excluding cannabis

• Healthy Volunteers Group:

  • Evolving psychiatric pathology (axis I of the DSM IV, measured at the MINI) excluding anxiety disorder
  • Presence of developmental disorder of oral language or written language revealed on clinical examination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: early psychotic symptoms; This group includes patients with ARMS and those with FEP. Although they are not in the same place in the continuum of psychosis, these patients benefit from the same language assessment and CAST, do not benefit from the TLC or the MINI, and the data from their neuropsychological and psychiatric assessment will be used , which is why we have chosen to bring them together in the same arm. They are between 16 and 35 years old and are cared for as part of their usual follow-up at the CPN (Nancy Psychotherapeutic Center). They must have received the diagnosis of ARMS and FEP according to the criteria of CAARMS and SPI-A.	Behavioral: Language assessment; The proposed speech and language therapy assessment will consist of a battery of standardized tests that speech and language therapists can use to assess the language skills in reception and expression of adult patients. Concerning the assessment of the interactions between working memory and semantic abilities, a complete protocol has been developed.; Other Names: Speech and language therapy assessment; Combination product: CAST - Cannabis Abuse Screening Test; The purpose of this questionnaire is to approximate participants' cannabis consumption and to assess any disorders associated with cannabis consumption. It will be offered to all participants, patients and healthy controls
Experimental: patients with schizophrenia; The schizophrenic patients group will benefit from language assessment, TLC and CAST. They are between 18 and 55 years old and are cared for as part of their usual follow-up at the CPN. They must have been diagnosed with schizophrenia according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria.	Behavioral: Language assessment; The proposed speech and language therapy assessment will consist of a battery of standardized tests that speech and language therapists can use to assess the language skills in reception and expression of adult patients. Concerning the assessment of the interactions between working memory and semantic abilities, a complete protocol has been developed.; Other Names: Speech and language therapy assessment; Combination product: CAST - Cannabis Abuse Screening Test; The purpose of this questionnaire is to approximate participants' cannabis consumption and to assess any disorders associated with cannabis consumption. It will be offered to all participants, patients and healthy controls; Behavioral: TLC - Scale for the Assessment of Thought, Language, and Communication; This scale is frequently used in psychiatry and is used to measure formal thought disorders in patients suffering from psychosis. As part of this study, it will be intended for patients suffering from schizophrenia
Experimental: healthy controls; The control group for this study will be made up of volunteers between the ages of 16 and 55, not suffering from any mental disorder detected on the MINI or from a developmental disorder of oral or written language. They will also benefit from an assessment of cannabis use using the CAST.	Behavioral: Language assessment; The proposed speech and language therapy assessment will consist of a battery of standardized tests that speech and language therapists can use to assess the language skills in reception and expression of adult patients. Concerning the assessment of the interactions between working memory and semantic abilities, a complete protocol has been developed.; Other Names: Speech and language therapy assessment; Combination product: CAST - Cannabis Abuse Screening Test; The purpose of this questionnaire is to approximate participants' cannabis consumption and to assess any disorders associated with cannabis consumption. It will be offered to all participants, patients and healthy controls; Behavioral: MINI - Mini International Neuropsychiatric Interview; This scale corresponds to a rapid assessment of the psychiatric and psychological state of patients. It helps detect any psychiatric disorders. Here, it will be offered to volunteers who are part of the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
language assessment performance score	complete speech therapy assessment evaluating each language domain. and is based on the completion of a speech therapy assessment test and on the assessment of language abilities by the experimental speech therapist.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAARMS Speech Disorganization Severity Score	CAARMS: Comprehensive Assessment of At Risk Mental State	day 1
Severity score for the disordered items of the course of thought of the SPI-A	SPI-A:Schizophrenia Proneness Instrument	day 1
Severity score for speech disorganization and formal thought disorders on the TLC Scale	TLC: Thinking, Language and Communication Rating Scale	day 1
Neuropsychological rating scales scores (CVLT)	CVLT (California Verbal Learning test) (quantitative variable): CVLT: number of correct recognitions	day 1
Neuropsychological rating scales scores (CVLT total)	CVLT (California Verbal Learning test) (quantitative variable): CVLT total: total number of words recalled during the test Recognition	day 1
Neuropsychological rating scales scores (Front and back spans)	Front and back spans (quantitative variable) Front span size (number of digits recalled in front order)	day 1
Neuropsychological rating scales scores (Front and back spans 2)	Front and back spans (quantitative variable) Reverse span size (number of digits recalled in reverse order)	day 1
Neuropsychological rating scales scores (TAP 1)	TAP- Working Memory :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)	day 1
Neuropsychological rating scales scores (TAP 2)	TAP- Sustained attention :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)	day 1
Neuropsychological rating scales scores (TAP 3)	TAP- Flexibility :Number of errors TAP(Test of Attentional Performance) (quantitative variable)	day 1
Neuropsychological rating scales scores (TAP 4)	TAP- Incompatibility TAP(Test of Attentional Performance) (quantitative variable)	day 1
Neuropsychological rating scales scores (TAP 5)	TAP- Divided attention	day 1
Cannabis Abuse Screening Test (CAST) score	CAST: Cannabis Abuse Screening Test	day 1

Collaborators and Investigators

• Sponsor: Centre Psychothérapique de Nancy
• Investigators: Principal Investigator: Florent Bernardin, PhD, Centre Psychothérapeutique de Nancy

Publications and helpful links

General Publications

• Majerus S. Language repetition and short-term memory: an integrative framework. Front Hum Neurosci. 2013 Jul 12;7:357. doi: 10.3389/fnhum.2013.00357. eCollection 2013.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Estimated): January 23, 2025
• Study Completion (Estimated): January 23, 2026

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Communication Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Language Disorders
• Other Study ID Numbers: 2023-A00949-36

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