Psychoneuroendocrinological Efficacy Study of an Integrative-kinesiological to a Cognitive-behavioural Intervention With Healthy Individuals
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Area under curve with respect to increase of salivary cortisol titer
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ready to participate in randomly one of the three groups
- •mentally and physically healthy
- •Sufficient German-speaking abilities to participate in the training
排除标准
- •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)
结局指标
主要结局
Area under curve with respect to increase of salivary cortisol titer
时间窗: 8x during TSST
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
次要结局
- Perceived Stress(Baseline, post intervention and follow up)
- Sense of Coherence(Baseline, post intervention and follow up)
- Salivary alpha amylase reactivity to the TSST(8x during TSST)
- self efficacy expectancy(Baseline, post intervention and follow up)