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临床试验/NCT04444180
NCT04444180已完成不适用

The Predictive Role of Self Representation in Transition of Individuals at Clinical High Risk for Psychosis -- a Study on the Clinical Application of Virtual Hand Illusion

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Behavioral indicators

研究概览

简要总结

Schizophrenia is one of the most consumptive diseases, which brings great loss to patients and their families, and even to the society. Clinical High Risk for Psychosis (CHR) is a concept put forward on the basis of the prodromal stage of schizophrenia. Over the past 20 years, the identification and intervention of CHR has become the focus of psychiatric research, with the primary goal of early identification of biomarkers of susceptibility to schizophrenia and the development of individualized interventions to prevent or delay progression. Longitudinal studies have shown that CHR converted to schizophrenia mainly within two years, with a risk of about 30 percent. Self-disorder is one of the core characteristics of schizophrenia. The two most basic experiences of self-representation are sense of ownership and sense of agency. Sense of ownership refers to the sense that "I" perceives "my" body, while sense of agency refers to the sense that "I" experiences "my" actions and their consequences are initiated by "me". Some studies have shown that patients with schizophrenia show defects in the sense of ownership and agency. The most commonly used paradigm for observing "sense of ownership" and "sense of agency" is the rubber hand illusion (RHI) or the virtual hand illusion (VHI). In this study, the VHI experimental paradigm will be used to detect the self-representation of the individuals at high risk for psychosis, and the clinical outcome will be observed for one year.The hypothesis is that the subjects who exhibit abnormal illusion experience in VHI experiment are more likely to transition into psychotic disorders.

详细描述

This study is conducted according to the tenets of the Declaration of Helsinki. All participants are recruited at the Shanghai Mental Health Center (SMHC) or its affiliate, the Shanghai Psychotherapy and Psychological Counseling Center (SPCC) with written informed consent, approved by the Research Ethics Committee of SMHC. For those younger than 18 years, both the adolescents and their next of kin or legal guardians are provided informed consents. The outpatients are recommended by doctors to participate in our CHR screening. After being screened and interviewed, those who meet the inclusion criteria are informed and signed written informed consent. Once the subjects are recruited, clinical evaluation, VHI and MCCB test will be conducted. In addition, CHR individuals will be followed up at one-year node.

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
11 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • For CHR individuals, meet the criteria of psychosis-risk syndromes after rating by structured interview for psychosis high risk syndrome.
  • For FES patients, meet diagnostic criteria for schizophrenia in the DSM-IV.
  • For HC individuals, gender composition, age range, educational level are matched with CHR individuals.
  • Understand and sign written informed consent.

排除标准

  • For CHR individuals, exclude individuals with other axis I or II mental disorders, which can explain the abnormal experience.
  • For CHR and FES patients, exclude those patients taking antipsychotics for more than two weeks.
  • For HC individuals, exclude those with family history of mental disorders
  • With a history of substance dependence.
  • Use of medications that may affect mental and cognitive functions.
  • With central nervous system disorder, that cuase symptoms or interfere with judgment.
  • Traumatic brain injury score is 7 or more.
  • With serious or unstable physical diseases.
  • With perceptual developmental disorders.

结局指标

主要结局

Behavioral indicators

时间窗: Baseline

To compare the behavioral performance in VHI experimental paradigm among the three groups of CHR, FES, and HC

Predictive indicators

时间窗: One-year follow-up node

To analyze the predictive role of self-representation in transition of CHR into psychosis

次要结局

  • Resting-state brain functional connectivity (FC)(Baseline)
  • Event-related potential technique(Baseline)
  • Neurocognitive function(Baseline)
  • Other predictive indicators(One-year follow-up node)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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