NCT06464848

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.

Trial Health

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Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

June 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

June 13, 2024

Last Update Submit

August 19, 2025

Conditions

Keywords

First episode psychosis

Outcome Measures

Primary Outcomes (1)

  • Narrative identity between groups according to life history task

    Narrative identity calculated from five narratives scored by the clinician considering agency, communion, redemption/contamination, affective tone, exploratory processing, growth, construction of meaning, elaboration of facts and interpretations, affective tone, ending valence, temporal/causal/thematic coherence and overall coherence.

    Day 0

Secondary Outcomes (18)

  • Multidimensional subjective well-being between groups

    Day 0

  • Psychopathology symptoms between FEP and chronic groups

    Day 0

  • Personal recovery between FEP and chronic groups

    Day 0

  • Personality between groups

    Day 0

  • Childhood trauma between groups

    Day 0

  • +13 more secondary outcomes

Study Arms (3)

FEP

Participants recruited from PEPsy-CM trial

Other: Narrative identity task

Chronic

Participants recruited from psychiatric department of CHU de Nimes

Other: Narrative identity task

Controls

Recruited from social media and word of mouth

Other: Narrative identity task

Interventions

All participants will be asked to develop five personal narratives in response to different types of questions: trauma, transgression, negative memory, self-definition, and turning point. For each story, participants will be asked to provide details of where they were, who they were with, what happened and how they and others reacted, what happened, how they reacted and how others reacted (if at all).

ChronicControlsFEP

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • 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.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Nimes University Hospital

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Julie Jourdan

    CHU de Nimes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 18, 2024

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations