Comparison of the Efficacy of an Integrative-kinesiological to a Cognitive-behavioural Intervention (IKSIT)
Psychoneuroendocrinological Efficacy Study of an Integrative-kinesiological to a Cognitive-behavioural Intervention With Healthy Individuals
Stress is a common problem with significant consequences for health. It can be a trigger for somatic diseases as well as psychological disorders and leads through missed working days and healthcare cost to a high economic loss. It is for health and economic reasons essential to develop and evaluate effective interventions that can inoculate against stress and build inner strength.
A cognitive-behavioural training for groups that is well evaluated and has shown to be effective is the Stress-Inoculation-Training by Meichenbaum. As the public utilization of methods of the complementary and alternative medicine is increasing a rigorous evaluation is needed. Integrative Kinesiology is a popular method that has been said to be effective against stress and its symptoms.
The investigators propose a randomized controlled evaluation and comparison of the interventions to each other and to a waiting-list control group. Hypothesis: Healthy volunteers attending a two dayseminar will show significantly reduced psychobiological reactivity, decreased stress perception and less anxiety to a standardized psychosocial stress test compared to the waiting list group. A total of 64 healthy volunteers will be randomly assigned to one of the three groups. The efficacy of the interventions will be measured through the Trier Social Stress Test (TSST) to measure the psychobiological stress reactivity.
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Zurich、瑞士、8032
- University of Zurich
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Ready to participate in randomly one of the three groups
- mentally and physically healthy
- Sufficient German-speaking abilities to participate in the training
Exclusion Criteria:
- previous experience with Integrative Kinesiology or cognitive-behavioural therapy
- previous experience with the Trier Social Stress Test
- daily alcohol consumption: > two alcoholic drinks
- daily tobacco consumption: > 5 cigarettes per day
- any kind of drug abuse
- pregnancy, after the second trimenon
- intake ofe hormonal compounds (birth control pill and hormon replacement therapy)
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Cognitive behavioural Intervention
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Two day seminar
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实验性的:Integrative Kinesiology Intervention
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Two day seminar
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无干预:Waiting-List control group
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Area under curve with respect to increase of salivary cortisol titer
大体时间:8x during TSST
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TSST evaluation day will take place between 2 weeks and one month on average after the treatments are finished. Trier Social Stress Tests procedure will last close to two hours. Samples are collected at: T + 02; +25; +38; +48; +58; + 1:08; +1:23; + 1.38 |
8x during TSST
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Salivary alpha amylase reactivity to the TSST
大体时间:8x during TSST
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TSST evaluation day will take place between 2 weeks and one month on average after the treatments are finished. Trier Social Stress Tests procedure will last close to two hours. Samples are collected at: T + 02; +25; +38; +48; +58; + 1:08; +1:23; + 1.38 |
8x during TSST
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Sense of Coherence
大体时间:Baseline, post intervention and follow up
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Baseline: After recruitment and acceptance to the study Post: One week after the training is fulfilled Follow-up: One week after the TSST Measured by: Sense of Coherence questionnaire (SOC-L9) |
Baseline, post intervention and follow up
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Perceived Stress
大体时间:Baseline, post intervention and follow up
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Baseline: After recruitment and acceptance to the study Post: One week after the training is fulfilled Follow-up: One week after the TSST Measured by: Perceived Stress Scale (PSS) |
Baseline, post intervention and follow up
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self efficacy expectancy
大体时间:Baseline, post intervention and follow up
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Baseline: After recruitment and acceptance to the study Post: One week after the training is fulfilled Follow-up: One week after the TSST Measured by: Self-efficacy-expectancy questionnaire (SWE) |
Baseline, post intervention and follow up
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合作者和调查者
调查人员
- 首席研究员:Lars B. Sonderegger、University of Zurich
- 学习椅:Reinhard Saller, Prof.、University of Zurich
- 学习椅:Ulrike Ehlert, Prof.、University of Zurich
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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