Меню
Набор скоро начнётся NCT07330843

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

Наблюдательное Psychosis Mental Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Narrative identity task.
Кому может быть актуально
Состояния в реестре: Psychosis, Mental Disorder. Базовые параметры: 16 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Вмешательства

  • Другое Narrative identity task
    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.

Первичные конечные точки

  • 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?" [Срок оценки: 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?" [Срок оценки: 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?" [Срок оценки: 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?" [Срок оценки: 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?" [Срок оценки: 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?" [Срок оценки: 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?" [Срок оценки: 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?" [Срок оценки: 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?" [Срок оценки: 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?" [Срок оценки: Month 24]
Вторичные конечные точки (12)
  • Narrative identity between groups [Срок оценки: Baseline (Day 0)]
  • Narrative identity between groups [Срок оценки: Month 6]
  • Narrative identity between groups [Срок оценки: Month 12]
  • Narrative identity between groups [Срок оценки: Month 18]
  • Narrative identity between groups [Срок оценки: Month 24]
  • General health-related quality of life between groups [Срок оценки: Baseline (day 0)]
  • General health-related quality of life between groups [Срок оценки: Month 6]
  • General health-related quality of life between groups [Срок оценки: Month 12]
  • General health-related quality of life between groups [Срок оценки: Month 18]
  • General health-related quality of life between groups [Срок оценки: Month 24]
  • Health-related quality of life between groups [Срок оценки: Baseline (day 0)]
  • Health-related quality of life between groups [Срок оценки: Month 6]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • CHU de Nîmes — Nîmes

Идентификаторы

NCT: NCT07330843 · LOCAL/2025/THESE/JJ-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗