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临床试验/NCT03525093
NCT03525093已完成不适用

A Hypnotherapeutic Group Training to Improve Coping With Perceived Stress - a Prospective Controlled Interventional Multicenter Trial

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年5月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Perceived Stress on Visual Analogue Scale

研究概览

简要总结

This prospective controlled study aims to test a 5 week group hypnosis training as intervention to improve coping with perceived psychological stress.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy or health-stable participants between 18 and 65 years with increased perceived stress for at least 3 months
  • Perceived stress in the last week on the visual analog scale> 40 mm (VAS 0 - 100 mm)
  • Ability to consent and sign declaration of consent

排除标准

  • Current or planned participation in a stress management exercise within the next 17 weeks
  • Current use of psychotherapeutic treatment
  • Presence of moderate or severe acute or chronic disease
  • Presence of an acute or chronic mental disorder
  • Participation in a study within the last 2 months prior to enrollment
  • Lack of understanding of the German language

研究组 & 干预措施

Hypnosis + health education

Active Comparator

5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home plus health education booklet on coping with stress

干预措施: Hypnosis (Behavioral)

Health education alone

Other

Patients receive a health education booklet to improve coping with stress

干预措施: Health education (Behavioral)

结局指标

主要结局

Perceived Stress on Visual Analogue Scale

时间窗: 5 weeks

Visual Analogue Scale of perceived stress in the last week, 0-100 mm (0=no stress; 100 = extreme stress)

次要结局

  • Cohens Perceived Stress Scale 10 Items(5 weeks, 12 weeks)
  • Stress reduction on Likert Scale(5 weeks, 12 weeks)
  • SF 36 Quality of Life(5 weeks, 12 weeks)
  • Perceived Stress on Visual Analogue Scale(12 weeks)
  • Allgemeine Depressionsskala (ADS-K)(5 weeks, 12 weeks)
  • General Self Efficacy Scale (Schwarzer)(5 weeks, 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benno Brinkhaus

Prof. Dr. med.

Charite University, Berlin, Germany

研究点 (2)

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