- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06464848
Narrative Identity and Its Relationship to Subjective Multidimensional Well-being in First Episode Psychosis (PEPsy-Identity)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Julie Jourdan
- Phone Number: 04.66.68.34.26
- Email: julie.jourdan@chu-nimes.fr
Study Locations
-
-
Gard
-
Nîmes, Gard, France, 30029
- Department of Psychiatry, Nimes University Hospital
-
Contact:
- Anissa Megzari
- Phone Number: 04.66.68.42.36
- Email: drc@chu-nimes.fr
-
Sub-Investigator:
- Aurélie Schandrin
-
Principal Investigator:
- Julie Jourdan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population will consist of three study groups:
- Patients with a first psychotic episode (FEP group)
- Controls, representative of the general French population (control group)
- Patients with a diagnosis of psychotic or bipolar disorder ("chronic" group). All three groups will be matched for age, sex and socio-educational level.
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
FEP
Participants recruited from PEPsy-CM trial
|
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).
|
|
Chronic
Participants recruited from psychiatric department of CHU de Nimes
|
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).
|
|
Controls
Recruited from social media and word of mouth
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Narrative identity between groups according to life history task
Time Frame: Day 0
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multidimensional subjective well-being between groups
Time Frame: Day 0
|
PERMA-Profiler score.
A 15-item questionnaire measured on 11-item Likert scales.
Higher scores indicate greater well-being.
An overall well-being score is calculated by creating an average score for each item, and subscale scores are calculated by averaging the three items in each subscale
|
Day 0
|
|
Psychopathology symptoms between FEP and chronic groups
Time Frame: Day 0
|
Positive and negative symptom scale (PANSS).
The positive scale ranges from 7 to 49, the negative scale from 8 to 56, the hostility scale from 6 to 46, the disorganization scale from 5 to 35, and the anxiety scale from 4 to 28.
The total score ranges from 30 to 210.
|
Day 0
|
|
Personal recovery between FEP and chronic groups
Time Frame: Day 0
|
Stage of Recovery Instrument (STORI).
Ten themes are evaluated, each comprising five items ranging from 0 "Not at all true" to 5 "Quite true", corresponding to the five stages of personal recovery.
A score is calculated for each stage, ranging from 0 to 50, and the participant is assigned to the stage with the highest score.
|
Day 0
|
|
Personality between groups
Time Frame: Day 0
|
10-item Big Five Inventory (BFI-10).
The BFI-10 is a 10-item scale assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability and openness
|
Day 0
|
|
Childhood trauma between groups
Time Frame: Day 0
|
Childhood Trauma Questionnaire (CTQ).
The short version of the CTQ consists of 28 items, including a 3-item denial scale and five 5-item scales.
The scale items are a Likert-type scale with five response options (from 1 = "never true" to 5 = "very often true")
|
Day 0
|
|
Patient functioning between groups
Time Frame: Day 0
|
Global Assessment of Functioning (GAF).
Scores range from 0-100, whereby lower scores represent lower functioning
|
Day 0
|
|
Anxiety and depression between groups
Time Frame: Day 0
|
Hospital Anxiety and Depression Scale (HADS).
A 14-item questionnaire of which 7 assess depression and 7 anxiety.
The sum of the item scores for each subscale produces an anxiety score and/or a depression score
|
Day 0
|
|
Social and individual performance between groups
Time Frame: Day 0
|
Personal and Social Performance scale (PSP).
Higher scores correspond to better personal and social functioning, scores from 91 to 100 correspond to more than adequate functioning, while scores below 30 correspond to such poor functioning that intensive supervision is required
|
Day 0
|
|
General quality of life between groups
Time Frame: Day 0
|
World Health Organization Quality Of Life Brief (WHOQOL-BREF).
The WHOQOL-bref has four types of five-point response scales, allowing assessment of intensity (Not at all-Extremely), ability (Not at all-Completely), frequency (Never-Always) and evaluation (Very dissatisfied/Very bad-Very satisfied/Very good), which vary according to the items
|
Day 0
|
|
Autobiographical memory function between groups
Time Frame: Day 0
|
Thinking About Life Experiences scale (TALE-15).
This self-questionnaire consists of two general questions, followed by 15 items specific to autobiographical memory functions, each consisting of 5 items.
The response items are associated with a 5-point Likert scale ranging from "Almost never" to "Very frequently".
|
Day 0
|
|
Insight between FEP and chronic groups
Time Frame: Day 0
|
Birchwood Insight Scale (BIS).
The questionnaire measures multidimensional assessment of insight, comprising 8 questions (3-point Likert scale: "agree", "disagree" or "unsure").
The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
|
Day 0
|
|
Health-related quality of life between groups
Time Frame: Day 0
|
EuroQol-5Dimension (EQ-5D-5L) questionnaire.
This questionnaire comprises five items representing the 5 dimensions of quality of life and a 0-100 visual analog scale.
The answers are combined into a 5-digit number describing the patient's health status e.g., health status "11111" indicates the absence of problems
|
Day 0
|
|
Depression between groups
Time Frame: Day 0
|
Beck Depression Inventory (BDI-11).
|
Day 0
|
|
Medical adherence between FEP and chronic groups
Time Frame: Day 0
|
Medication Adherence Rating Scale (MARS).
The 10 items assess behaviors, attitudes and treatment experience.
Scores range from 0 to 10
|
Day 0
|
|
Patient-perceived improvement in clinical condition between FEP and chronic groups
Time Frame: Day 0
|
Clinical Global Impression (CGI).
The questionnaire comprises two measures: Severity and Improvement, both measured on a scale of 1 to 7
|
Day 0
|
|
Verbal fluency between groups
Time Frame: Day 0
|
Participants must list as many words as possible beginning with the letter "P", belonging to the semantic category "animals".
|
Day 0
|
|
Word recall and recognition between groups
Time Frame: Day 0
|
California Verbal Learning Test (CVLT-11).
Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall).
The word list is presented as a shopping list.
|
Day 0
|
|
Non-verbal reasoning between groups
Time Frame: Day 0
|
Matrices test taken from the Wechsler Adult Intelligence Scale to measure non-verbal reasoning abilities, general visual intelligence and perceptual organization skills.
|
Day 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: Julie Jourdan, CHU de Nîmes
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOCAL/2023/JJ-03
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
product manufactured in and exported from the U.S.
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.
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