An observational study in Psychosis, sponsored by Centre Hospitalier Universitaire de Nīmes. Not yet recruiting at 1 site in France. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational
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.
1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.
This study's planned enrollment of 48 is below the median of 150 across 245 observational studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
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The study population will consist of three study groups:
Inclusion Criteria:
Inclusion criteria fir FEP group:
Inclusion criteria for the "Chronic" group:
Exclusion Criteria:
Exclusion criteria for FEP group:
Exclusion criteria for the "Control" group:
Participants recruited from PEPsy-CM trial
Other: Narrative identity task
Participants recruited from psychiatric department of CHU de Nimes
Other: Narrative identity task
Recruited from social media and word of mouth
Other: Narrative identity task
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).
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.
Time frame: Day 0
Multidimensional subjective well-being between groups
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
Time frame: Day 0
Psychopathology symptoms between FEP and chronic groups
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.
Time frame: Day 0
Personal recovery between FEP and chronic groups
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.
Time frame: Day 0
Personality between groups
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
Time frame: Day 0
Childhood trauma between groups
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")
Time frame: Day 0
Patient functioning between groups
Global Assessment of Functioning (GAF). Scores range from 0-100, whereby lower scores represent lower functioning
Time frame: Day 0
Anxiety and depression between groups
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
Time frame: Day 0
Social and individual performance between groups
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
Time frame: Day 0
General quality of life between groups
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
Time frame: Day 0
Autobiographical memory function between groups
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".
Time frame: Day 0
Insight between FEP and chronic groups
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.
Time frame: Day 0
Health-related quality of life between groups
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
Time frame: Day 0
Depression between groups
Beck Depression Inventory (BDI-11).
Time frame: Day 0
Medical adherence between FEP and chronic groups
Medication Adherence Rating Scale (MARS). The 10 items assess behaviors, attitudes and treatment experience. Scores range from 0 to 10
Time frame: Day 0
Patient-perceived improvement in clinical condition between FEP and chronic groups
Clinical Global Impression (CGI). The questionnaire comprises two measures: Severity and Improvement, both measured on a scale of 1 to 7
Time frame: Day 0
Verbal fluency between groups
Participants must list as many words as possible beginning with the letter "P", belonging to the semantic category "animals".
Time frame: Day 0
Word recall and recognition between groups
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.
Time frame: Day 0
Non-verbal reasoning between groups
Matrices test taken from the Wechsler Adult Intelligence Scale to measure non-verbal reasoning abilities, general visual intelligence and perceptual organization skills.
Time frame: Day 0
Plan to share: No
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Centre Hospitalier Universitaire de Nīmes