跳至主要内容
临床试验/NCT03318640
NCT03318640终止不适用

Effect of Mindfulness (MBSR) on the Parasympathetic System and Cognition in Schizophrenia

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
34
试验地点
2
主要终点
High Frequency spectral power

研究概览

简要总结

Mindfulness (innovative and integrative practice in care) allows the individual to adapt his/her behavior (physical and emotional), in a stressful environment, by regulating cardiac activity, especially the parasympathetic system. In schizophrenia, despite the positive effect of treatments on symptoms (delusions and hallucinations), patients have altered markers of the parasympathetic (high frequency, HF) system. The investigator propose a session of Mindfulness Based Stress Reduction (MBSR) for patients suffering from schizophrenia in order to measure the impact on the parasympathetic system (HF), self-awareness (being well in one's body and being aware of their own actions; EASE) and cognition (attention) in relation to the management of conflicts or emotions. The study compare with patients who receive a session of techniques based on the management of emotions and social cognition (cinemotion, Michael's Game and Tom Remed).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • DSM-IV diagnosis of schizophrenia (men only)
  • aged 18-55
  • with no change in antipsychotic medication and clinical status within four weeks prior to the study
  • affiliates or entitled to a social security scheme
  • who have given their informed consent before participating in the study.

排除标准

  • History of head trauma, neurological disease or not stabilized serious physical illness
  • Disorders related to the use of a psychoactive substance, as defined by the DSM-IV (abuse, dependence or withdrawal) within 6 months
  • Beta blocking and anti-arrhythmic medications.

结局指标

主要结局

High Frequency spectral power

时间窗: 2 months

High Frequency spectral power

次要结局

  • Score(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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