Comparison of the Efficacy of an Integrative-kinesiological to a Cognitive-behavioural Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Psychoneuroendocrinological Efficacy Study of an Integrative-kinesiological to a Cognitive-behavioural Intervention With Healthy Individuals

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Training
* Behavioral: Integrative Kinesiology Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioural Intervention<br> | Behavioral: Cognitive Behavioural Training<br>* Two day seminar<br>|
| Experimental: Integrative Kinesiology Intervention<br> | Behavioral: Integrative Kinesiology Intervention<br>* Two day seminar<br>|
| No Intervention: Waiting-List control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve with respect to increase of salivary cortisol titer | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary alpha amylase reactivity to the 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 | 8x during TSST | 
| Sense of Coherence | 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 | 
| Perceived Stress | 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 | 
| self efficacy expectancy | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Prevention, Stress, Kinesiology, Healthy, cognitive behavioural therapy, Prevention