AzTrials
AzTrials

PsychosisPEPIDNCT07330843

Assessment and Evolution of Narrative Identity and Its Relationship to Subjective Multidimensional Well-being and Multidimensional Recovery in First Episode Psychosis

An observational study of Psychosis and Mental Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 30 years
Conditions the study is for
Psychosis, Mental Disorder
What is being tested?
Narrative identity task
How many people
96 participants
Where
1 siteFrance
Study dates
Jan 2026to Jul 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 30 years
  • All sexes
  • Child, Adult

Study population: 406 / 5,000 Three groups of participants will be formed: 1. a group of participants meeting the criteria for a FEP; 2. a group of "chronic" participants diagnosed with a psychotic disorder (recruited from patients at the Carémeau University Hospital in Nîmes); and 3. a control group of participants, representative of the general population (recruited through social media advertisements).

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julie Jourdan contact

04.66.68.34.26

julie.jourdan@chu-nimes.fr

France1 site

  • CHU de Nîmes

    Nîmes, 30029

    Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr

    Julie Jourdan

Other trials in France

About this study

Official title: 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.

Being tested
Narrative identity task
Keywords
Narrative identity
Medical subject headings
Psychotic Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Narrative identity taskOther

    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.

Study groups in NCT07330843
Study groupRoleWhat they receive
First episode psychosisNot described
Receives: Other: Narrative identity task
Chronicparticipants diagnosed with a psychotic disorder
Receives: Other: Narrative identity task
ControlNot described
Receives: Other: Narrative identity task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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?"

    7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"

    Measured: Baseline (Day 0)

  2. 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?"

    7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"

    Measured: Month 6

  3. 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?"

    7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"

    Measured: Month 12

  4. 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?"

    7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"

    Measured: Month 18

  5. 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?"

    7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"

    Measured: Month 24

  6. Emotional intensity according to the question: "When you think about this story in your life, how intense is this story in your life?"

    7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -

    Measured: Baseline (Day 0)

  7. Emotional intensity according to the question: "When you think about this story in your life, how intense is this story in your life?"

    7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -

    Measured: Month 6

  8. Emotional intensity according to the question: "When you think about this story in your life, how intense is this story in your life?"

    7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -

    Measured: Month 12

  9. Emotional intensity according to the question: "When you think about this story in your life, how intense is this story in your life?"

    7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -

    Measured: Month 18

  10. Emotional intensity according to the question: "When you think about this story in your life, how intense is this story in your life?"

    7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -

    Measured: Month 24

  11. Emotional tone according to the question "When you think about this story in your life, is it generally negative, mixed, neutral, or positive?"

    4-point scale ranging from 0 "Negative" to 4 "Positive."

    Measured: Baseline (day 0)

  12. Emotional tone according to the question "When you think about this story in your life, is it generally negative, mixed, neutral, or positive?"

    4-point scale ranging from 0 "Negative" to 4 "Positive."

    Measured: Month 6

  13. Emotional tone according to the question "When you think about this story in your life, is it generally negative, mixed, neutral, or positive?"

    4-point scale ranging from 0 "Negative" to 4 "Positive."

    Measured: Month 12

  14. Emotional tone according to the question "When you think about this story in your life, is it generally negative, mixed, neutral, or positive?"

    4-point scale ranging from 0 "Negative" to 4 "Positive."

    Measured: Month 18

  15. Emotional tone according to the question "When you think about this story in your life, is it generally negative, mixed, neutral, or positive?"

    4-point scale ranging from 0 "Negative" to 4 "Positive."

    Measured: Month 24

Secondary outcomes (80)

  1. Narrative identity between groups

    PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being

    Measured: Baseline (Day 0)

  2. Narrative identity between groups

    PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being

    Measured: Month 6

  3. Narrative identity between groups

    PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being

    Measured: Month 12

  4. Narrative identity between groups

    PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being

    Measured: Month 18

  5. Narrative identity between groups

    PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being

    Measured: Month 24

  6. General health-related quality of life between groups

    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).

    Measured: Baseline (day 0)

  7. General health-related quality of life between groups

    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).

    Measured: Month 6

  8. General health-related quality of life between groups

    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).

    Measured: Month 12

  9. General health-related quality of life between groups

    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).

    Measured: Month 18

  10. General health-related quality of life between groups

    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).

    Measured: Month 24

  11. Health-related quality of life between groups

    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).

    Measured: Baseline (day 0)

  12. Health-related quality of life between groups

    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).

    Measured: Month 6

  13. Health-related quality of life between groups

    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).

    Measured: Month 12

  14. Health-related quality of life between groups

    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).

    Measured: Month 18

  15. Health-related quality of life between groups

    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).

    Measured: Month 24

  16. Anxiety and depression between groups

    Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress

    Measured: Baseline (Day 0)

  17. Anxiety and depression between groups

    Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress

    Measured: Month 6

  18. Anxiety and depression between groups

    Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress

    Measured: Month 12

  19. Anxiety and depression between groups

    Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress

    Measured: Month 18

  20. Anxiety and depression between groups

    Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress

    Measured: Month 24

  21. Autobiographical memory between groups

    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."

    Measured: Baseline (day 0)

  22. Autobiographical memory between groups

    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."

    Measured: Month 6

  23. Autobiographical memory between groups

    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."

    Measured: Month 12

  24. Autobiographical memory between groups

    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."

    Measured: Month 18

  25. Autobiographical memory between groups

    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."

    Measured: Month 24

  26. Personality type between groups

    Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.

    Measured: Baseline (day 0)

  27. Personality type between groups

    Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.

    Measured: Month 6

  28. Personality type between groups

    Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.

    Measured: Month 12

  29. Personality type between groups

    Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.

    Measured: Month 18

  30. Personality type between groups

    Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.

    Measured: Month 24

  31. Symptomatology of psychotic disorders in the FEP and chronic groups

    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.

    Measured: Baseline (day 0)

  32. Symptomatology of psychotic disorders in the FEP and chronic groups

    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.

    Measured: Month 6

  33. Symptomatology of psychotic disorders in the FEP and chronic groups

    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.

    Measured: Month 12

  34. Symptomatology of psychotic disorders in the FEP and chronic groups

    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.

    Measured: Month 18

  35. Symptomatology of psychotic disorders in the FEP and chronic groups

    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.

    Measured: Month 24

  36. Overall functioning in the FEP and chronic groups

    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

    Measured: Baseline (day 0)

  37. Overall functioning in the FEP and chronic groups

    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

    Measured: Month 6

  38. Overall functioning in the FEP and chronic groups

    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

    Measured: Month 12

  39. Overall functioning in the FEP and chronic groups

    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

    Measured: Month 18

  40. Overall functioning in the FEP and chronic groups

    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

    Measured: Month 24

  41. Personal recovery in the FEP and chronic groups

    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

    Measured: Baseline (day 0)

  42. Personal recovery in the FEP and chronic groups

    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

    Measured: Month 6

  43. Personal recovery in the FEP and chronic groups

    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

    Measured: Month 12

  44. Personal recovery in the FEP and chronic groups

    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

    Measured: Month 18

  45. Personal recovery in the FEP and chronic groups

    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

    Measured: Month 24

  46. Social and individual performance in the FEP and chronic groups

    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.

    Measured: Baseline (day 0)

  47. Social and individual performance in the FEP and chronic groups

    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.

    Measured: Month 6

  48. Social and individual performance in the FEP and chronic groups

    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.

    Measured: Month 12

  49. Social and individual performance in the FEP and chronic groups

    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.

    Measured: Month 18

  50. Social and individual performance in the FEP and chronic groups

    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.

    Measured: Month 24

  51. Improvement of clinical state in the FEP and chronic groups

    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.

    Measured: Baseline (day 0)

  52. Improvement of clinical state in the FEP and chronic groups

    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.

    Measured: Month 6

  53. Improvement of clinical state in the FEP and chronic groups

    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.

    Measured: Month 12

  54. Improvement of clinical state in the FEP and chronic groups

    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.

    Measured: Month 18

  55. Improvement of clinical state in the FEP and chronic groups

    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.

    Measured: Month 24

  56. Awareness of the disorders in the FEP and chronic groups

    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.

    Measured: Baseline (day 0)

  57. Awareness of the disorders in the FEP and chronic groups

    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.

    Measured: Month 6

  58. Awareness of the disorders in the FEP and chronic groups

    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.

    Measured: Month 12

  59. Awareness of the disorders in the FEP and chronic groups

    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.

    Measured: Month 18

  60. Awareness of the disorders in the FEP and chronic groups

    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.

    Measured: Month 24

  61. Abstract verbal reasoning in the FEP and chronic groups

    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

    Measured: Baseline (day 0)

  62. Abstract verbal reasoning in the FEP and chronic groups

    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

    Measured: Month 6

  63. Abstract verbal reasoning in the FEP and chronic groups

    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

    Measured: Month 12

  64. Abstract verbal reasoning in the FEP and chronic groups

    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

    Measured: Month 18

  65. Abstract verbal reasoning in the FEP and chronic groups

    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

    Measured: Month 24

  66. Non-verbal abstract problem solving in the FEP and chronic groups

    Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings

    Measured: Baseline (day 0)

  67. Non-verbal abstract problem solving in the FEP and chronic groups

    Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings

    Measured: Month 6

  68. Non-verbal abstract problem solving in the FEP and chronic groups

    Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings

    Measured: Month 12

  69. Non-verbal abstract problem solving in the FEP and chronic groups

    Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings

    Measured: Month 18

  70. Non-verbal abstract problem solving in the FEP and chronic groups

    Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings

    Measured: Month 24

  71. Treatment adherence in the FEP and chronic groups

    Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.

    Measured: Baseline (day 0)

  72. Treatment adherence in the FEP and chronic groups

    Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.

    Measured: Month 6

  73. Treatment adherence in the FEP and chronic groups

    Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.

    Measured: Month 12

  74. Treatment adherence in the FEP and chronic groups

    Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.

    Measured: Month 18

  75. Treatment adherence in the FEP and chronic groups

    Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.

    Measured: Month 24

  76. Episodic memory between groups

    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).

    Measured: Baseline (day 0)

  77. Episodic memory between groups

    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).

    Measured: Month 6

  78. Episodic memory between groups

    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).

    Measured: Month 12

  79. Episodic memory between groups

    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).

    Measured: Month 18

  80. Episodic memory between groups

    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).

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2026
  2. Study startJan 2026 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07330843
Sponsor's protocol ID
LOCAL/2025/THESE/JJ-01
Acronym
PEPID
Status last verified
Nov 2025
First submitted
18 Dec 2025
Last updated
9 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Psychosis and Mental Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julie Jourdan (04.66.68.34.26, julie.jourdan@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07330843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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