跳至主要内容
临床试验/NCT06263933
NCT06263933Unknown不适用

Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode

Centre hospitalier de Ville-Evrard, France2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月13日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
The level of the increasing of The INSIGHT scale

研究概览

简要总结

Controlled, prospective, qualitative and quantitative trial. The goal of this trial is to evaluate the mutual assistance early intervention device efficacy and its impact on insight and personal recovery of participants living with a first psychotic episode. This intervention lasts 5 days with 1 session per day of 1 hour 30 minutes. Three evaluations, before the intervention, after intervention and 1 month after the hospitalization's end.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Man or woman between 18 and 40 years old
  • First psychotic episode under the guidance of a doctor
  • Brief psycotic trouble (SM-V)
  • Presenting a first psychiatry hospitalization (all modalities hospitalizations combined)
  • Fluent in French language (read and written)
  • Patient affiliated to a social protection system or beneficiary of Medical Aid of State
  • Patient having signed informed consent for his participation in the protocol

排除标准

  • Patients whose clinical condition does not allow them to participate in research
  • Patients placed in isolation rooms during the intervention

结局指标

主要结局

The level of the increasing of The INSIGHT scale

时间窗: at baseline (T0) and at 5 days after the intervention's beginning (T1).

Used the "Echelle de conscience de trouble" - insight scale. There are 8 items, with 3 choices for each items : agree, disagree, unsure. The time is 5 minutes. Maximum score = 12, very good Insight Minimum score= 0, No Insight 9 and more= good insight

次要结局

  • The semi-structured interview(At baseline (T0) and at 1 month after the hospitalization's end (T2).)
  • The increase of Recovery Scale(At baseline (T0) and at 5 days after the intervention's beginning (T1).)

研究者

发起方
Centre hospitalier de Ville-Evrard, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dominique JANUEL

head of research center and clinical professor

Centre hospitalier de Ville-Evrard, France

研究点 (2)

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