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临床试验/NCT07330843
NCT07330843尚未招募不适用

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

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
96
试验地点
1
主要终点
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?"

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

First episode psychosis

干预措施: Narrative identity task (Other)

Chronic

participants diagnosed with a psychotic disorder

干预措施: Narrative identity task (Other)

Control

干预措施: Narrative identity task (Other)

结局指标

主要结局

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?"

时间窗: Month 24

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

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

时间窗: Month 24

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

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

时间窗: Month 24

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

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?"

时间窗: Baseline (Day 0)

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

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?"

时间窗: Month 6

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

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?"

时间窗: Month 12

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

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?"

时间窗: Month 18

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

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

时间窗: Baseline (Day 0)

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

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

时间窗: Month 6

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

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

时间窗: Month 12

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

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

时间窗: Month 18

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

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

时间窗: Baseline (day 0)

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

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

时间窗: Month 6

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

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

时间窗: Month 12

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

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

时间窗: Month 18

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

次要结局

  • Narrative identity between groups(Month 24)
  • General health-related quality of life between groups(Month 24)
  • Health-related quality of life between groups(Month 24)
  • Anxiety and depression between groups(Month 24)
  • Autobiographical memory between groups(Month 24)
  • Personality type between groups(Month 24)
  • Symptomatology of psychotic disorders in the FEP and chronic groups(Month 24)
  • Overall functioning in the FEP and chronic groups(Month 24)
  • Personal recovery in the FEP and chronic groups(Month 24)
  • Social and individual performance in the FEP and chronic groups(Month 24)
  • Improvement of clinical state in the FEP and chronic groups(Month 24)
  • Awareness of the disorders in the FEP and chronic groups(Month 24)
  • Abstract verbal reasoning in the FEP and chronic groups(Month 24)
  • Non-verbal abstract problem solving in the FEP and chronic groups(Month 24)
  • Treatment adherence in the FEP and chronic groups(Month 24)
  • Episodic memory between groups(Month 24)
  • Narrative identity between groups(Baseline (Day 0))
  • Narrative identity between groups(Month 6)
  • Narrative identity between groups(Month 12)
  • Narrative identity between groups(Month 18)
  • General health-related quality of life between groups(Baseline (day 0))
  • General health-related quality of life between groups(Month 6)
  • General health-related quality of life between groups(Month 12)
  • General health-related quality of life between groups(Month 18)
  • Health-related quality of life between groups(Baseline (day 0))
  • Health-related quality of life between groups(Month 6)
  • Health-related quality of life between groups(Month 12)
  • Health-related quality of life between groups(Month 18)
  • Anxiety and depression between groups(Baseline (Day 0))
  • Anxiety and depression between groups(Month 6)
  • Anxiety and depression between groups(Month 12)
  • Anxiety and depression between groups(Month 18)
  • Autobiographical memory between groups(Baseline (day 0))
  • Autobiographical memory between groups(Month 6)
  • Autobiographical memory between groups(Month 12)
  • Autobiographical memory between groups(Month 18)
  • Personality type between groups(Baseline (day 0))
  • Personality type between groups(Month 6)
  • Personality type between groups(Month 12)
  • Personality type between groups(Month 18)
  • Symptomatology of psychotic disorders in the FEP and chronic groups(Baseline (day 0))
  • Symptomatology of psychotic disorders in the FEP and chronic groups(Month 6)
  • Symptomatology of psychotic disorders in the FEP and chronic groups(Month 12)
  • Symptomatology of psychotic disorders in the FEP and chronic groups(Month 18)
  • Overall functioning in the FEP and chronic groups(Baseline (day 0))
  • Overall functioning in the FEP and chronic groups(Month 6)
  • Overall functioning in the FEP and chronic groups(Month 12)
  • Overall functioning in the FEP and chronic groups(Month 18)
  • Personal recovery in the FEP and chronic groups(Baseline (day 0))
  • Personal recovery in the FEP and chronic groups(Month 6)
  • Personal recovery in the FEP and chronic groups(Month 12)
  • Personal recovery in the FEP and chronic groups(Month 18)
  • Social and individual performance in the FEP and chronic groups(Baseline (day 0))
  • Social and individual performance in the FEP and chronic groups(Month 6)
  • Social and individual performance in the FEP and chronic groups(Month 12)
  • Social and individual performance in the FEP and chronic groups(Month 18)
  • Improvement of clinical state in the FEP and chronic groups(Baseline (day 0))
  • Improvement of clinical state in the FEP and chronic groups(Month 6)
  • Improvement of clinical state in the FEP and chronic groups(Month 12)
  • Improvement of clinical state in the FEP and chronic groups(Month 18)
  • Awareness of the disorders in the FEP and chronic groups(Baseline (day 0))
  • Awareness of the disorders in the FEP and chronic groups(Month 6)
  • Awareness of the disorders in the FEP and chronic groups(Month 12)
  • Awareness of the disorders in the FEP and chronic groups(Month 18)
  • Abstract verbal reasoning in the FEP and chronic groups(Baseline (day 0))
  • Abstract verbal reasoning in the FEP and chronic groups(Month 6)
  • Abstract verbal reasoning in the FEP and chronic groups(Month 12)
  • Abstract verbal reasoning in the FEP and chronic groups(Month 18)
  • Non-verbal abstract problem solving in the FEP and chronic groups(Baseline (day 0))
  • Non-verbal abstract problem solving in the FEP and chronic groups(Month 6)
  • Non-verbal abstract problem solving in the FEP and chronic groups(Month 12)
  • Non-verbal abstract problem solving in the FEP and chronic groups(Month 18)
  • Treatment adherence in the FEP and chronic groups(Baseline (day 0))
  • Treatment adherence in the FEP and chronic groups(Month 6)
  • Treatment adherence in the FEP and chronic groups(Month 12)
  • Treatment adherence in the FEP and chronic groups(Month 18)
  • Episodic memory between groups(Baseline (day 0))
  • Episodic memory between groups(Month 6)
  • Episodic memory between groups(Month 12)
  • Episodic memory between groups(Month 18)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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