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临床试验/NCT06464848
NCT06464848尚未招募不适用

Narrative Identity and Its Relationship to Subjective Multidimensional Well-being in First Episode Psychosis

Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
48
试验地点
2
主要终点
Narrative identity between groups according to life history task

研究概览

简要总结

The transition between adolescence and adulthood (generally defined as ages 18 to 25) is a key developmental window for narrative identity and psychotic disorders. Narrative identity is positively associated with mental health. This study will focus on the acquisition of narrative identity in First Episode Psychosis (FEP) and its impact on multidimensional subjective well-being.

The study authors hypothesize that levels of the various components of narrative identity would be lower in the FEP group than in the "chronic" and control groups, and in the "chronic" group versus control group. Given the paucity contradictory nature of the published literature, no hypotheses have been formulated regarding these correlations and predictions. Instead, this study will remain an exploratory analysis in the different samples.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • Inclusion criteria fir FEP group:
  • Patient managed in the psychiatry department (consultation or hospitalization) for a FEP defined by :
  • Presence of positive psychotic symptoms (delirium(s) and/or hallucination(s) and/or conceptual disorganization) for at least one week, either every day or at least 3 times a week for at least one hour.
  • Never having taken neuroleptic antipsychotic treatment (except antipsychotic treatment started 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 disorder of the schizophrenic spectrum or other psychotic disorder, bipolar I or II disorder with psychotic features congruent and not congruent with mood, substance-induced bipolar disorder with psychotic features congruent and not congruent with mood, major depressive disorder with psychotic features congruent and not congruent with mood.
  • Inclusion criteria for the "Chronic" group:
  • Patient 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 disorder of the schizophrenic spectrum or other psychotic disorder, bipolar I or II disorder with psychotic features congruent and not congruent with mood, substance-induced bipolar disorder with psychotic features congruent and not congruent with mood, major depressive disorder with psychotic features congruent and not congruent with mood.

排除标准

  • The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
  • The subject unable to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient pregnant or breastfeeding
  • Patient with history of traumatic brain injury
  • Patient with moderate to severe mental retardation (IQ≤ 55)
  • Exclusion criteria for FEP group:
  • FEP related to a drug-induced psychotic disorder or due to another medical condition
  • Exclusion criteria for the "Control" group:
  • Participant with lifetime experience of FEP
  • Participant with a diagnosis of a 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 disorder of the schizophrenic spectrum or other psychotic disorder, bipolar I or II disorder with psychotic features congruent and not congruent with mood, substance-induced bipolar disorder with psychotic features congruent and not congruent with mood, major depressive disorder with psychotic features congruent and not congruent with mood.

结局指标

主要结局

Narrative identity between groups according to life history task

时间窗: Day 0

Narrative identity calculated from five narratives scored by the clinician considering agency, communion, redemption/contamination, affective tone, exploratory processing, growth, construction of meaning, elaboration of facts and interpretations, affective tone, ending valence, temporal/causal/thematic coherence and overall coherence.

次要结局

  • Personality between groups(Day 0)
  • Childhood trauma between groups(Day 0)
  • Insight between FEP and chronic groups(Day 0)
  • Multidimensional subjective well-being between groups(Day 0)
  • Psychopathology symptoms between FEP and chronic groups(Day 0)
  • Personal recovery between FEP and chronic groups(Day 0)
  • Patient functioning between groups(Day 0)
  • Social and individual performance between groups(Day 0)
  • General quality of life between groups(Day 0)
  • Patient-perceived improvement in clinical condition between FEP and chronic groups(Day 0)
  • Verbal fluency between groups(Day 0)
  • Depression between groups(Day 0)
  • Anxiety and depression between groups(Day 0)
  • Autobiographical memory function between groups(Day 0)
  • Health-related quality of life between groups(Day 0)
  • Medical adherence between FEP and chronic groups(Day 0)
  • Word recall and recognition between groups(Day 0)
  • Non-verbal reasoning between groups(Day 0)

研究者

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

研究点 (2)

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