Clinical trial NCT06464848: Narrative Identity and Its Relationship to Subjective Multidimensional Well-being in First Episode Psychosis
Official title: Narrative Identity and Its Relationship to Subjective Multidimensional Well-being in First Episode Psychosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Psychosis
Keywords: First episode psychosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of three study groups:

1. Patients with a first psychotic episode (FEP group)
2. Controls, representative of the general French population (control group)
3. Patients with a diagnosis of psychotic or bipolar disorder ("chronic" group). All three groups will be matched for age, sex and socio-educational level.

Brief summary: The transition between adolescence and adulthood (generally defined as ages 18 to 25) is a key developmental window for narrative identity and psychotic disorders. Narrative identity is positively associated with mental health. This study will focus on the acquisition of narrative identity in First Episode Psychosis (FEP) and its impact on multidimensional subjective well-being.

The study authors hypothesize that levels of the various components of narrative identity would be lower in the FEP group than in the "chronic" and control groups, and in the "chronic" group versus control group. Given the paucity contradictory nature of the published literature, no hypotheses have been formulated regarding these correlations and predictions. Instead, this study will remain an exploratory analysis in the different samples.


Eligibility criteria: Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Inclusion criteria fir FEP group:

• Patient managed in the psychiatry department (consultation or hospitalization) for a FEP defined by :

* Presence of positive psychotic symptoms (delirium(s) and/or hallucination(s) and/or conceptual disorganization) for at least one week, either every day or at least 3 times a week for at least one hour.
* Never having taken neuroleptic antipsychotic treatment (except antipsychotic treatment started for the current episode)
* Disorder meeting DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder lasting more than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder lasting more than 7 days, other specific or non-specific disorder of the schizophrenic spectrum or other psychotic disorder, bipolar I or II disorder with psychotic features congruent and not congruent with mood, substance-induced bipolar disorder with psychotic features congruent and not congruent with mood, major depressive disorder with psychotic features congruent and not congruent with mood.

Inclusion criteria for the "Chronic" group:

• Patient diagnosed with a disorder meeting DSM 5 criteria for more than 18 months from the following list: delusional disorder, brief psychotic disorder lasting more than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder lasting more than 7 days, other specific or non-specific disorder of the schizophrenic spectrum or other psychotic disorder, bipolar I or II disorder with psychotic features congruent and not congruent with mood, substance-induced bipolar disorder with psychotic features congruent and not congruent with mood, major depressive disorder with psychotic features congruent and not congruent with mood.

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject unable to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient pregnant or breastfeeding
* Patient with history of traumatic brain injury
* Patient with moderate to severe mental retardation (IQ≤ 55)

Exclusion criteria for FEP group:

• FEP related to a drug-induced psychotic disorder or due to another medical condition

Exclusion criteria for the "Control" group:

* Participant with lifetime experience of FEP
* Participant with a diagnosis of a disorder meeting DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder lasting more than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder lasting more than 7 days, other specific or non-specific disorder of the schizophrenic spectrum or other psychotic disorder, bipolar I or II disorder with psychotic features congruent and not congruent with mood, substance-induced bipolar disorder with psychotic features congruent and not congruent with mood, major depressive disorder with psychotic features congruent and not congruent with mood.

Primary outcomes:
measure: Narrative identity between groups according to life history task
timeFrame: Day 0
Secondary outcomes:
measure: Multidimensional subjective well-being between groups
timeFrame: Day 0
measure: Psychopathology symptoms between FEP and chronic groups
timeFrame: Day 0
measure: Personal recovery between FEP and chronic groups
timeFrame: Day 0
measure: Personality between groups
timeFrame: Day 0
measure: Childhood trauma between groups
timeFrame: Day 0
measure: Patient functioning between groups
timeFrame: Day 0
measure: Anxiety and depression between groups
timeFrame: Day 0
measure: Social and individual performance between groups
timeFrame: Day 0
measure: General quality of life between groups
timeFrame: Day 0
measure: Autobiographical memory function between groups
timeFrame: Day 0
measure: Insight between FEP and chronic groups
timeFrame: Day 0
measure: Health-related quality of life between groups
timeFrame: Day 0
measure: Depression between groups
timeFrame: Day 0
measure: Medical adherence between FEP and chronic groups
timeFrame: Day 0
measure: Patient-perceived improvement in clinical condition between FEP and chronic groups
timeFrame: Day 0
measure: Verbal fluency between groups
timeFrame: Day 0
measure: Word recall and recognition between groups
timeFrame: Day 0
measure: Non-verbal reasoning between groups
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Department of Psychiatry, Nimes University Hospital
state: Gard
Study officials:
affiliation: CHU de Nimes
name: Julie Jourdan
role: PRINCIPAL_INVESTIGATOR
References: