- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07330843
Assessment and Evolution of Narrative Identity and Its Relationship to Subjective Multidimensional Well-being and Multidimensional Recovery in First Episode Psychosis (PEPID)
Évaluation et évolution de l'identité Narrative et de Son Lien Avec le Bien-être Multidimensionnel Subjectif et le rétablissement Multidimensionnel Dans le Premier épisode Psychotique
First episode psychosis (FEP) constitutes an important subgroup within psychotic disorders, as the acute impact of a disorder at the time of diagnosis may differ from its long-term impact over the following decades. Narrative is identified as a sense of personal agency, of belonging to a social group, metacognition, and well-being. Patients with schizophrenia have lower levels of agency and communion compared to HIV-positive participants. However, the themes of agency and communion and metacognition do not reflect all factors representing narrative identity. In order to measure well-being, it is also necessary to introduce a specific and multidimensional measure that will allow a more precise understanding of the phenomenon.
In FEP, a link has been demonstrated between the specificity of self-recollection and functional outcomes. Given that the transitional developmental stage between adolescence and adulthood is a key developmental window for narrative identity as well as psychotic disorders and that narrative identity is positively associated with mental health, this study will therefore focus on the acquisition of narrative identity in the FEP. It will investigate the extent to which narrative identity has an impact on multidimensional subjective well-being and whether it can predict multidimensional subjective well-being over time. The study investigators hypothesize that the levels of the various components of narrative identity would be lower in cases of FEP compared to patients with other "chronic" psychotic conditions and controls.
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
-
-
-
Nîmes, France, 30029
- CHU de Nîmes
-
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
Accepts Healthy Volunteers
Sampling Method
Study Population
406 / 5,000
Three groups of participants will be formed:
- a group of participants meeting the criteria for a FEP;
- a group of "chronic" participants diagnosed with a psychotic disorder (recruited from patients at the Carémeau University Hospital in Nîmes); and
- a control group of participants, representative of the general population (recruited through social media advertisements).
Description
Inclusion Criteria:
- Subject who has given their free and informed consent.
- Subject who has signed the consent form.
- Subject who is a member of or beneficiary of a health insurance plan.
For the FEP group:
- Patient treated in a psychiatric department (consultation or hospitalization) for a FEP defined by:
- Presence of positive psychotic symptoms (delusions and/or hallucinations and/or conceptual disorganization) evolving for at least one week, either every day or at least 3 times a week for at least one hour per occasion
- Never having taken neuroleptic treatment with an antipsychotic purpose (with the exception of antipsychotic treatment initiated 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 schizophrenia spectrum disorder or other psychotic disorder, bipolar disorder I or II with mood-congruent and mood-incongruent psychotic features, substance-induced bipolar disorder with mood-congruent and mood-incongruent psychotic features, major depressive disorder with mood-congruent and mood-incongruent psychotic features
For the "Chronic" group:
• Patients 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 schizophrenia spectrum disorder or other psychotic disorder, bipolar I or II disorder with mood-congruent and mood-incongruent psychotic features, substance-induced bipolar disorder with mood-congruent and mood-incongruent psychotic features, major depressive disorder with mood-congruent and mood-incongruent psychotic features
Exclusion Criteria:
- The subject is participating in category 1 RIPH or a clinical drug trial or clinical investigation study, or is in a period of exclusion determined by a previous study
- The patient is unable to express consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Pregnant or breastfeeding subject.
- Patient with a history of traumatic brain injury
- Patient with moderate to severe mental retardation (IQ ≤ 55)
For the FEP group:
• FEP related to a drug-induced psychotic disorder or due to another medical condition
For the "Control" group:
- Patient with lifetime experience of FEP
- Patient with a diagnosis of a disorder meeting DSM-5 criteria from the following list: delusional disorder, brief psychotic disorder lasting more than 7 days, schizophrenia-like disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder lasting more than 7 days, other specific or non-specific schizophrenia spectrum disorder or other psychotic disorder, bipolar I or II disorder with mood-congruent and mood-incongruent psychotic features, bipolar disorder with mood-congruent and mood-incongruent psychotic features substance-induced mood, major depressive disorder with psychotic features congruent and incongruent with mood
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control
|
Participants will be asked to elaborate five personal narratives in response to the different types of questions: trauma, transgression, negative memory, self-definition, and turning point.
|
|
First episode psychosis
|
Participants will be asked to elaborate five personal narratives in response to the different types of questions: trauma, transgression, negative memory, self-definition, and turning point.
|
|
Chronic
participants diagnosed with a psychotic disorder
|
Participants will be asked to elaborate five personal narratives in response to the different types of questions: trauma, transgression, negative memory, self-definition, and turning point.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional valence according to the question: "When you think about this story in your life, how positive or negative is this story in your life?"
Time Frame: Baseline (Day 0)
|
7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"
|
Baseline (Day 0)
|
|
Emotional valence according to the question: "When you think about this story in your life, how positive or negative is this story in your life?"
Time Frame: Month 6
|
7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"
|
Month 6
|
|
Emotional valence according to the question: "When you think about this story in your life, how positive or negative is this story in your life?"
Time Frame: Month 12
|
7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"
|
Month 12
|
|
Emotional valence according to the question: "When you think about this story in your life, how positive or negative is this story in your life?"
Time Frame: Month 18
|
7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"
|
Month 18
|
|
Emotional valence according to the question: "When you think about this story in your life, how positive or negative is this story in your life?"
Time Frame: Month 24
|
7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"
|
Month 24
|
|
Emotional intensity according to the question: "When you think about this story in your life, how intense is this story in your life?"
Time Frame: Baseline (Day 0)
|
7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -
|
Baseline (Day 0)
|
|
Emotional intensity according to the question: "When you think about this story in your life, how intense is this story in your life?"
Time Frame: Month 6
|
7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -
|
Month 6
|
|
Emotional intensity according to the question: "When you think about this story in your life, how intense is this story in your life?"
Time Frame: Month 12
|
7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -
|
Month 12
|
|
Emotional intensity according to the question: "When you think about this story in your life, how intense is this story in your life?"
Time Frame: Month 18
|
7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -
|
Month 18
|
|
Emotional intensity according to the question: "When you think about this story in your life, how intense is this story in your life?"
Time Frame: Month 24
|
7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -
|
Month 24
|
|
Emotional tone according to the question "When you think about this story in your life, is it generally negative, mixed, neutral, or positive?"
Time Frame: Baseline (day 0)
|
4-point scale ranging from 0 "Negative" to 4 "Positive."
|
Baseline (day 0)
|
|
Emotional tone according to the question "When you think about this story in your life, is it generally negative, mixed, neutral, or positive?"
Time Frame: Month 6
|
4-point scale ranging from 0 "Negative" to 4 "Positive."
|
Month 6
|
|
Emotional tone according to the question "When you think about this story in your life, is it generally negative, mixed, neutral, or positive?"
Time Frame: Month 12
|
4-point scale ranging from 0 "Negative" to 4 "Positive."
|
Month 12
|
|
Emotional tone according to the question "When you think about this story in your life, is it generally negative, mixed, neutral, or positive?"
Time Frame: Month 18
|
4-point scale ranging from 0 "Negative" to 4 "Positive."
|
Month 18
|
|
Emotional tone according to the question "When you think about this story in your life, is it generally negative, mixed, neutral, or positive?"
Time Frame: Month 24
|
4-point scale ranging from 0 "Negative" to 4 "Positive."
|
Month 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Narrative identity between groups
Time Frame: Baseline (Day 0)
|
PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being
|
Baseline (Day 0)
|
|
Narrative identity between groups
Time Frame: Month 6
|
PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being
|
Month 6
|
|
Narrative identity between groups
Time Frame: Month 12
|
PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being
|
Month 12
|
|
Narrative identity between groups
Time Frame: Month 18
|
PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being
|
Month 18
|
|
Narrative identity between groups
Time Frame: Month 24
|
PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being
|
Month 24
|
|
General health-related quality of life between groups
Time Frame: Baseline (day 0)
|
EQ5D-5L questionnaire comprising five items representing the five dimensions, and a visual analog scale ranging from 0 to 100 (100 referring to the "best possible health state").
The responses are then into a 5-digit number describing the patient's health state (e.g "11111" indicates the absence of problems).
|
Baseline (day 0)
|
|
General health-related quality of life between groups
Time Frame: Month 6
|
EQ5D-5L questionnaire comprising five items representing the five dimensions, and a visual analog scale ranging from 0 to 100 (100 referring to the "best possible health state").
The responses are then into a 5-digit number describing the patient's health state (e.g "11111" indicates the absence of problems).
|
Month 6
|
|
General health-related quality of life between groups
Time Frame: Month 12
|
EQ5D-5L questionnaire comprising five items representing the five dimensions, and a visual analog scale ranging from 0 to 100 (100 referring to the "best possible health state").
The responses are then into a 5-digit number describing the patient's health state (e.g "11111" indicates the absence of problems).
|
Month 12
|
|
General health-related quality of life between groups
Time Frame: Month 18
|
EQ5D-5L questionnaire comprising five items representing the five dimensions, and a visual analog scale ranging from 0 to 100 (100 referring to the "best possible health state").
The responses are then into a 5-digit number describing the patient's health state (e.g "11111" indicates the absence of problems).
|
Month 18
|
|
General health-related quality of life between groups
Time Frame: Month 24
|
EQ5D-5L questionnaire comprising five items representing the five dimensions, and a visual analog scale ranging from 0 to 100 (100 referring to the "best possible health state").
The responses are then into a 5-digit number describing the patient's health state (e.g "11111" indicates the absence of problems).
|
Month 24
|
|
Health-related quality of life between groups
Time Frame: Baseline (day 0)
|
WHOQOL-Brief: a 26-item questionnaire including one item on overall quality of life, one item assessing general health, and one item from each of the 24 facets of the WHOQOL-100.
Four types of five-point response scales measure intensity (Not at all-Extremely), capacity (Not at all-Completely), frequency (Never-Always), and evaluation (Very dissatisfied/Very poor-Very satisfied/Very good).
|
Baseline (day 0)
|
|
Health-related quality of life between groups
Time Frame: Month 6
|
WHOQOL-Brief: a 26-item questionnaire including one item on overall quality of life, one item assessing general health, and one item from each of the 24 facets of the WHOQOL-100.
Four types of five-point response scales measure intensity (Not at all-Extremely), capacity (Not at all-Completely), frequency (Never-Always), and evaluation (Very dissatisfied/Very poor-Very satisfied/Very good).
|
Month 6
|
|
Health-related quality of life between groups
Time Frame: Month 12
|
WHOQOL-Brief: a 26-item questionnaire including one item on overall quality of life, one item assessing general health, and one item from each of the 24 facets of the WHOQOL-100.
Four types of five-point response scales measure intensity (Not at all-Extremely), capacity (Not at all-Completely), frequency (Never-Always), and evaluation (Very dissatisfied/Very poor-Very satisfied/Very good).
|
Month 12
|
|
Health-related quality of life between groups
Time Frame: Month 18
|
WHOQOL-Brief: a 26-item questionnaire including one item on overall quality of life, one item assessing general health, and one item from each of the 24 facets of the WHOQOL-100.
Four types of five-point response scales measure intensity (Not at all-Extremely), capacity (Not at all-Completely), frequency (Never-Always), and evaluation (Very dissatisfied/Very poor-Very satisfied/Very good).
|
Month 18
|
|
Health-related quality of life between groups
Time Frame: Month 24
|
WHOQOL-Brief: a 26-item questionnaire including one item on overall quality of life, one item assessing general health, and one item from each of the 24 facets of the WHOQOL-100.
Four types of five-point response scales measure intensity (Not at all-Extremely), capacity (Not at all-Completely), frequency (Never-Always), and evaluation (Very dissatisfied/Very poor-Very satisfied/Very good).
|
Month 24
|
|
Anxiety and depression between groups
Time Frame: Baseline (Day 0)
|
Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress
|
Baseline (Day 0)
|
|
Anxiety and depression between groups
Time Frame: Month 6
|
Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress
|
Month 6
|
|
Anxiety and depression between groups
Time Frame: Month 12
|
Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress
|
Month 12
|
|
Anxiety and depression between groups
Time Frame: Month 18
|
Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress
|
Month 18
|
|
Anxiety and depression between groups
Time Frame: Month 24
|
Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress
|
Month 24
|
|
Autobiographical memory between groups
Time Frame: Baseline (day 0)
|
Thinking About Life Experiences scale (TALE-15): 17-item questionnaire consists of two general questions followed by 15 specific items related to the functions of autobiographical memory, each composed of 5 sub-items.
Responses are rated on a 5-point Likert scale ranging from "Almost never" to "Very frequently."
|
Baseline (day 0)
|
|
Autobiographical memory between groups
Time Frame: Month 6
|
Thinking About Life Experiences scale (TALE-15): 17-item questionnaire consists of two general questions followed by 15 specific items related to the functions of autobiographical memory, each composed of 5 sub-items.
Responses are rated on a 5-point Likert scale ranging from "Almost never" to "Very frequently."
|
Month 6
|
|
Autobiographical memory between groups
Time Frame: Month 12
|
Thinking About Life Experiences scale (TALE-15): 17-item questionnaire consists of two general questions followed by 15 specific items related to the functions of autobiographical memory, each composed of 5 sub-items.
Responses are rated on a 5-point Likert scale ranging from "Almost never" to "Very frequently."
|
Month 12
|
|
Autobiographical memory between groups
Time Frame: Month 18
|
Thinking About Life Experiences scale (TALE-15): 17-item questionnaire consists of two general questions followed by 15 specific items related to the functions of autobiographical memory, each composed of 5 sub-items.
Responses are rated on a 5-point Likert scale ranging from "Almost never" to "Very frequently."
|
Month 18
|
|
Autobiographical memory between groups
Time Frame: Month 24
|
Thinking About Life Experiences scale (TALE-15): 17-item questionnaire consists of two general questions followed by 15 specific items related to the functions of autobiographical memory, each composed of 5 sub-items.
Responses are rated on a 5-point Likert scale ranging from "Almost never" to "Very frequently."
|
Month 24
|
|
Personality type between groups
Time Frame: Baseline (day 0)
|
Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.
|
Baseline (day 0)
|
|
Personality type between groups
Time Frame: Month 6
|
Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.
|
Month 6
|
|
Personality type between groups
Time Frame: Month 12
|
Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.
|
Month 12
|
|
Personality type between groups
Time Frame: Month 18
|
Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.
|
Month 18
|
|
Personality type between groups
Time Frame: Month 24
|
Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.
|
Month 24
|
|
Symptomatology of psychotic disorders in the FEP and chronic groups
Time Frame: Baseline (day 0)
|
Positive and negative symptom scale (PANSS).
30 items measuring 5 subscales: positive, negative, disorganization, hostility, and anxiety.
Each item is rated on a 7-point Likert scale ranging from 1 (absent) to 7 (extreme).
The positive subscale ranges from 7 to 49, the negative subscale from 8 to 56, the hostility subscale from 6 to 46, the disorganization subscale from 5 to 35, and the anxiety subscale from 4 to 28.
The total score ranges from 30 to 210.
|
Baseline (day 0)
|
|
Symptomatology of psychotic disorders in the FEP and chronic groups
Time Frame: Month 6
|
Positive and negative symptom scale (PANSS).
30 items measuring 5 subscales: positive, negative, disorganization, hostility, and anxiety.
Each item is rated on a 7-point Likert scale ranging from 1 (absent) to 7 (extreme).
The positive subscale ranges from 7 to 49, the negative subscale from 8 to 56, the hostility subscale from 6 to 46, the disorganization subscale from 5 to 35, and the anxiety subscale from 4 to 28.
The total score ranges from 30 to 210.
|
Month 6
|
|
Symptomatology of psychotic disorders in the FEP and chronic groups
Time Frame: Month 12
|
Positive and negative symptom scale (PANSS).
30 items measuring 5 subscales: positive, negative, disorganization, hostility, and anxiety.
Each item is rated on a 7-point Likert scale ranging from 1 (absent) to 7 (extreme).
The positive subscale ranges from 7 to 49, the negative subscale from 8 to 56, the hostility subscale from 6 to 46, the disorganization subscale from 5 to 35, and the anxiety subscale from 4 to 28.
The total score ranges from 30 to 210.
|
Month 12
|
|
Symptomatology of psychotic disorders in the FEP and chronic groups
Time Frame: Month 18
|
Positive and negative symptom scale (PANSS).
30 items measuring 5 subscales: positive, negative, disorganization, hostility, and anxiety.
Each item is rated on a 7-point Likert scale ranging from 1 (absent) to 7 (extreme).
The positive subscale ranges from 7 to 49, the negative subscale from 8 to 56, the hostility subscale from 6 to 46, the disorganization subscale from 5 to 35, and the anxiety subscale from 4 to 28.
The total score ranges from 30 to 210.
|
Month 18
|
|
Symptomatology of psychotic disorders in the FEP and chronic groups
Time Frame: Month 24
|
Positive and negative symptom scale (PANSS).
30 items measuring 5 subscales: positive, negative, disorganization, hostility, and anxiety.
Each item is rated on a 7-point Likert scale ranging from 1 (absent) to 7 (extreme).
The positive subscale ranges from 7 to 49, the negative subscale from 8 to 56, the hostility subscale from 6 to 46, the disorganization subscale from 5 to 35, and the anxiety subscale from 4 to 28.
The total score ranges from 30 to 210.
|
Month 24
|
|
Overall functioning in the FEP and chronic groups
Time Frame: Baseline (day 0)
|
Global Assessment of Functioning (GAF).
This numerical scale (from 0 to 100) subjectively assesses functioning in social, occupational, and psychological domains.
Lower scores represent lower levels of functioning
|
Baseline (day 0)
|
|
Overall functioning in the FEP and chronic groups
Time Frame: Month 6
|
Global Assessment of Functioning (GAF).
This numerical scale (from 0 to 100) subjectively assesses functioning in social, occupational, and psychological domains.
Lower scores represent lower levels of functioning
|
Month 6
|
|
Overall functioning in the FEP and chronic groups
Time Frame: Month 12
|
Global Assessment of Functioning (GAF).
This numerical scale (from 0 to 100) subjectively assesses functioning in social, occupational, and psychological domains.
Lower scores represent lower levels of functioning
|
Month 12
|
|
Overall functioning in the FEP and chronic groups
Time Frame: Month 18
|
Global Assessment of Functioning (GAF).
This numerical scale (from 0 to 100) subjectively assesses functioning in social, occupational, and psychological domains.
Lower scores represent lower levels of functioning
|
Month 18
|
|
Overall functioning in the FEP and chronic groups
Time Frame: Month 24
|
Global Assessment of Functioning (GAF).
This numerical scale (from 0 to 100) subjectively assesses functioning in social, occupational, and psychological domains.
Lower scores represent lower levels of functioning
|
Month 24
|
|
Personal recovery in the FEP and chronic groups
Time Frame: Baseline (day 0)
|
Stage of recovery instrument (STORI): a 50-item questionnaire that evaluates the five stages of personal recovery.
Ten themes are assessed, each containing five items ranging from 0 "Not at all true" to 5 "Completely true," corresponding to the five stages of personal recovery.
A score is calculated for each stage, ranging from 0 to 50
|
Baseline (day 0)
|
|
Personal recovery in the FEP and chronic groups
Time Frame: Month 6
|
Stage of recovery instrument (STORI): a 50-item questionnaire that evaluates the five stages of personal recovery.
Ten themes are assessed, each containing five items ranging from 0 "Not at all true" to 5 "Completely true," corresponding to the five stages of personal recovery.
A score is calculated for each stage, ranging from 0 to 50
|
Month 6
|
|
Personal recovery in the FEP and chronic groups
Time Frame: Month 12
|
Stage of recovery instrument (STORI): a 50-item questionnaire that evaluates the five stages of personal recovery.
Ten themes are assessed, each containing five items ranging from 0 "Not at all true" to 5 "Completely true," corresponding to the five stages of personal recovery.
A score is calculated for each stage, ranging from 0 to 50
|
Month 12
|
|
Personal recovery in the FEP and chronic groups
Time Frame: Month 18
|
Stage of recovery instrument (STORI): a 50-item questionnaire that evaluates the five stages of personal recovery.
Ten themes are assessed, each containing five items ranging from 0 "Not at all true" to 5 "Completely true," corresponding to the five stages of personal recovery.
A score is calculated for each stage, ranging from 0 to 50
|
Month 18
|
|
Personal recovery in the FEP and chronic groups
Time Frame: Month 24
|
Stage of recovery instrument (STORI): a 50-item questionnaire that evaluates the five stages of personal recovery.
Ten themes are assessed, each containing five items ranging from 0 "Not at all true" to 5 "Completely true," corresponding to the five stages of personal recovery.
A score is calculated for each stage, ranging from 0 to 50
|
Month 24
|
|
Social and individual performance in the FEP and chronic groups
Time Frame: Baseline (day 0)
|
Personal and social performance scale (PSP): measures four domains of social and individual functioning (socially useful activities, personal and social relationships, self-care, disruptive and aggressive behaviors) and provides a score between 1 and 100, divided into 10 equal intervals to assess the degree of difficulty.
Higher scores correspond to better personal and social functioning, with scores of 91 to 100 indicating more than adequate functioning, while scores below 30 indicate such poor functioning that intensive supervision is required.
|
Baseline (day 0)
|
|
Social and individual performance in the FEP and chronic groups
Time Frame: Month 6
|
Personal and social performance scale (PSP): measures four domains of social and individual functioning (socially useful activities, personal and social relationships, self-care, disruptive and aggressive behaviors) and provides a score between 1 and 100, divided into 10 equal intervals to assess the degree of difficulty.
Higher scores correspond to better personal and social functioning, with scores of 91 to 100 indicating more than adequate functioning, while scores below 30 indicate such poor functioning that intensive supervision is required.
|
Month 6
|
|
Social and individual performance in the FEP and chronic groups
Time Frame: Month 12
|
Personal and social performance scale (PSP): measures four domains of social and individual functioning (socially useful activities, personal and social relationships, self-care, disruptive and aggressive behaviors) and provides a score between 1 and 100, divided into 10 equal intervals to assess the degree of difficulty.
Higher scores correspond to better personal and social functioning, with scores of 91 to 100 indicating more than adequate functioning, while scores below 30 indicate such poor functioning that intensive supervision is required.
|
Month 12
|
|
Social and individual performance in the FEP and chronic groups
Time Frame: Month 18
|
Personal and social performance scale (PSP): measures four domains of social and individual functioning (socially useful activities, personal and social relationships, self-care, disruptive and aggressive behaviors) and provides a score between 1 and 100, divided into 10 equal intervals to assess the degree of difficulty.
Higher scores correspond to better personal and social functioning, with scores of 91 to 100 indicating more than adequate functioning, while scores below 30 indicate such poor functioning that intensive supervision is required.
|
Month 18
|
|
Social and individual performance in the FEP and chronic groups
Time Frame: Month 24
|
Personal and social performance scale (PSP): measures four domains of social and individual functioning (socially useful activities, personal and social relationships, self-care, disruptive and aggressive behaviors) and provides a score between 1 and 100, divided into 10 equal intervals to assess the degree of difficulty.
Higher scores correspond to better personal and social functioning, with scores of 91 to 100 indicating more than adequate functioning, while scores below 30 indicate such poor functioning that intensive supervision is required.
|
Month 24
|
|
Improvement of clinical state in the FEP and chronic groups
Time Frame: Baseline (day 0)
|
Clinical global impression (CGI): a global observer-rated assessment tool that measures a patient's clinical condition before and after medical treatment.
It consists of two measures: Severity, which measures the severity of the patient's clinical condition; and Improvement, which assesses the improvement in the patient's clinical condition since the start of treatment, both on a scale of 1 to 7.
|
Baseline (day 0)
|
|
Improvement of clinical state in the FEP and chronic groups
Time Frame: Month 6
|
Clinical global impression (CGI): a global observer-rated assessment tool that measures a patient's clinical condition before and after medical treatment.
It consists of two measures: Severity, which measures the severity of the patient's clinical condition; and Improvement, which assesses the improvement in the patient's clinical condition since the start of treatment, both on a scale of 1 to 7.
|
Month 6
|
|
Improvement of clinical state in the FEP and chronic groups
Time Frame: Month 12
|
Clinical global impression (CGI): a global observer-rated assessment tool that measures a patient's clinical condition before and after medical treatment.
It consists of two measures: Severity, which measures the severity of the patient's clinical condition; and Improvement, which assesses the improvement in the patient's clinical condition since the start of treatment, both on a scale of 1 to 7.
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Month 12
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Improvement of clinical state in the FEP and chronic groups
Time Frame: Month 18
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Clinical global impression (CGI): a global observer-rated assessment tool that measures a patient's clinical condition before and after medical treatment.
It consists of two measures: Severity, which measures the severity of the patient's clinical condition; and Improvement, which assesses the improvement in the patient's clinical condition since the start of treatment, both on a scale of 1 to 7.
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Month 18
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Improvement of clinical state in the FEP and chronic groups
Time Frame: Month 24
|
Clinical global impression (CGI): a global observer-rated assessment tool that measures a patient's clinical condition before and after medical treatment.
It consists of two measures: Severity, which measures the severity of the patient's clinical condition; and Improvement, which assesses the improvement in the patient's clinical condition since the start of treatment, both on a scale of 1 to 7.
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Month 24
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Awareness of the disorders in the FEP and chronic groups
Time Frame: Baseline (day 0)
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Birchwood insight scale (BIS); multidimensional assessment of awareness of illness (insight) and includes 8 questions (3-point Likert scale: "agree," "disagree," or "uncertain").
The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
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Baseline (day 0)
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Awareness of the disorders in the FEP and chronic groups
Time Frame: Month 6
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Birchwood insight scale (BIS); multidimensional assessment of awareness of illness (insight) and includes 8 questions (3-point Likert scale: "agree," "disagree," or "uncertain").
The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
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Month 6
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Awareness of the disorders in the FEP and chronic groups
Time Frame: Month 12
|
Birchwood insight scale (BIS); multidimensional assessment of awareness of illness (insight) and includes 8 questions (3-point Likert scale: "agree," "disagree," or "uncertain").
The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
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Month 12
|
|
Awareness of the disorders in the FEP and chronic groups
Time Frame: Month 18
|
Birchwood insight scale (BIS); multidimensional assessment of awareness of illness (insight) and includes 8 questions (3-point Likert scale: "agree," "disagree," or "uncertain").
The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
|
Month 18
|
|
Awareness of the disorders in the FEP and chronic groups
Time Frame: Month 24
|
Birchwood insight scale (BIS); multidimensional assessment of awareness of illness (insight) and includes 8 questions (3-point Likert scale: "agree," "disagree," or "uncertain").
The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
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Month 24
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Abstract verbal reasoning in the FEP and chronic groups
Time Frame: Baseline (day 0)
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Similarities section of the Wechsler Adult Intelligence Scale (WAIS): For 18 pairs of words, the participant subject must identify the qualitative relationship between the two words
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Baseline (day 0)
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Abstract verbal reasoning in the FEP and chronic groups
Time Frame: Month 6
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Similarities section of the Wechsler Adult Intelligence Scale (WAIS): For 18 pairs of words, the participant subject must identify the qualitative relationship between the two words
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Month 6
|
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Abstract verbal reasoning in the FEP and chronic groups
Time Frame: Month 12
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Similarities section of the Wechsler Adult Intelligence Scale (WAIS): For 18 pairs of words, the participant subject must identify the qualitative relationship between the two words
|
Month 12
|
|
Abstract verbal reasoning in the FEP and chronic groups
Time Frame: Month 18
|
Similarities section of the Wechsler Adult Intelligence Scale (WAIS): For 18 pairs of words, the participant subject must identify the qualitative relationship between the two words
|
Month 18
|
|
Abstract verbal reasoning in the FEP and chronic groups
Time Frame: Month 24
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Similarities section of the Wechsler Adult Intelligence Scale (WAIS): For 18 pairs of words, the participant subject must identify the qualitative relationship between the two words
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Month 24
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Non-verbal abstract problem solving in the FEP and chronic groups
Time Frame: Baseline (day 0)
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Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings
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Baseline (day 0)
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Non-verbal abstract problem solving in the FEP and chronic groups
Time Frame: Month 6
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Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings
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Month 6
|
|
Non-verbal abstract problem solving in the FEP and chronic groups
Time Frame: Month 12
|
Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings
|
Month 12
|
|
Non-verbal abstract problem solving in the FEP and chronic groups
Time Frame: Month 18
|
Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings
|
Month 18
|
|
Non-verbal abstract problem solving in the FEP and chronic groups
Time Frame: Month 24
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Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings
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Month 24
|
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Treatment adherence in the FEP and chronic groups
Time Frame: Baseline (day 0)
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Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.
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Baseline (day 0)
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Treatment adherence in the FEP and chronic groups
Time Frame: Month 6
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Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.
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Month 6
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Treatment adherence in the FEP and chronic groups
Time Frame: Month 12
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Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.
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Month 12
|
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Treatment adherence in the FEP and chronic groups
Time Frame: Month 18
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Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.
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Month 18
|
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Treatment adherence in the FEP and chronic groups
Time Frame: Month 24
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Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.
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Month 24
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Episodic memory between groups
Time Frame: Baseline (day 0)
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California Verbal Learning Test--Second Edition (CVLT): in this word list recall and recognition test, the examiner reads a list of 16 nouns aloud at one-second intervals in a fixed order over five learning trials.
The participant is asked to recall as many words as possible in any order (free recall).
If subjects "cluster" words from each category, they are presumably using semantic organization.
Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall).
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Baseline (day 0)
|
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Episodic memory between groups
Time Frame: Month 6
|
California Verbal Learning Test--Second Edition (CVLT): in this word list recall and recognition test, the examiner reads a list of 16 nouns aloud at one-second intervals in a fixed order over five learning trials.
The participant is asked to recall as many words as possible in any order (free recall).
If subjects "cluster" words from each category, they are presumably using semantic organization.
Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall).
|
Month 6
|
|
Episodic memory between groups
Time Frame: Month 12
|
California Verbal Learning Test--Second Edition (CVLT): in this word list recall and recognition test, the examiner reads a list of 16 nouns aloud at one-second intervals in a fixed order over five learning trials.
The participant is asked to recall as many words as possible in any order (free recall).
If subjects "cluster" words from each category, they are presumably using semantic organization.
Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall).
|
Month 12
|
|
Episodic memory between groups
Time Frame: Month 18
|
California Verbal Learning Test--Second Edition (CVLT): in this word list recall and recognition test, the examiner reads a list of 16 nouns aloud at one-second intervals in a fixed order over five learning trials.
The participant is asked to recall as many words as possible in any order (free recall).
If subjects "cluster" words from each category, they are presumably using semantic organization.
Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall).
|
Month 18
|
|
Episodic memory between groups
Time Frame: Month 24
|
California Verbal Learning Test--Second Edition (CVLT): in this word list recall and recognition test, the examiner reads a list of 16 nouns aloud at one-second intervals in a fixed order over five learning trials.
The participant is asked to recall as many words as possible in any order (free recall).
If subjects "cluster" words from each category, they are presumably using semantic organization.
Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall).
|
Month 24
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Collaborators and Investigators
Investigators
- Principal Investigator: Julie Jourdan, Centre Hospitalier Universitaire de Nimes
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/2025/THESE/JJ-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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