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临床试验/NCT02390271
NCT02390271已完成4 期

Cardiac Coherence Training to Reduce Anxiety in Remitted Schizophrenia

Institut de Recherche Biomedicale des Armees0 个研究点目标入组 10 人开始时间: 2010年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
10
主要终点
psychometric outcome: Spielberger State Anxiety Inventory (S-STAI)

研究概览

简要总结

Introduction: Health care that addresses the emotional regulation capacity of patients with schizophrenia confronted with daily stress may contribute to a less anxious life. A psycho-physiological training (cardiac coherence training; CCT) focusing on emotion regulation is known to decrease anxiety for non-clinical individuals.

Methods: the investigators performed a pilot cross sectional survey to explore the benefits of CCT for clinically stable patients with schizophrenia. Ten patients were enrolled in the program consisting in height to twelve weekly one hour session program during a 2-month follow-up. Standardised questionnaires were used before and after the intervention assessing anxiety, well-being outcomes, and how patients deal with stress and stressors.

详细描述

Ten subjects, five women and five men, all volunteers, were included in the study. The patients were all clients of the rehabilitation center for psychotic disorders (Le Vinatier hospital) situated in Lyon, France. Criteria for entry into the study included: a Diagnostic and Statistical Manual of Mental Disorder-4 diagnosis of schizophrenia as confirmed by the Mini International Neuropsychiatric Interview for DSM-IV (MINI); age between 18 and 65; being clinically stable (i.e. not having required hospitalization or increases in medication as a result of an exacerbation of acute symptoms over the previous three months.

All subjects completed a set of "paper and pencil" standardized assessments at pre-intervention and immediately after the end of the intervention.

Trait and State anxiety was assessed using the French version of the Spielberger State-Trait-Anxiety Inventory (S-STAI).

Three questionnaires were used in order to evaluate the outcomes quality of life of patients. 1/ The Positive And Negative Syndrome Scale (PANSS); 2/ Patient's body/mind perceptions were assessed using mindfulness concept (Freiburg Mindfulness Inventory, FMI), and 3/ Patients' quality of life was evaluated using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).

One questionnaire was used to assess how patients deal with stress and stressors (the Derogatis Stress Profile, DSP).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosis of remitted schizophrenia

排除标准

  • •exacerbation of schizophrenic symptoms over the previous three months (hospitalization or increases in medication)

研究组 & 干预措施

emotion focused therapy training CCT

Experimental

The general training includes in an individual adjusted way the following techniques: biofeedback-assisted breathing classes that erase negative emotion involving the cardiac and limbic neural pathways, control one's own and other's emotions, mastering positive cognition and enhance self-concept, anchoring positive memories, learning how to recognize psychological reversal in others

干预措施: emotion focused therapy training (Other)

结局指标

主要结局

psychometric outcome: Spielberger State Anxiety Inventory (S-STAI)

时间窗: up to two months

outcomes assessed before and after the 3-month Cardiac Coherence Training

次要结局

  • psychometric outcome: Freiburg Mindfulness Inventory (FMI)(up to two months)

研究者

发起方
Institut de Recherche Biomedicale des Armees
申办方类型
Other Gov
责任方
Sponsor

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