Clinical trial NCT01331577: Comparison of the Efficacy of an Integrative-kinesiological to a Cognitive-behavioural Intervention
Official title: Psychoneuroendocrinological Efficacy Study of an Integrative-kinesiological to a Cognitive-behavioural Intervention With Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Healthy
Primary Prevention
Stress
Kinesiology
cognitive behavioural therapy
Prevention
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-04-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Area under curve with respect to increase of salivary cortisol titer
timeFrame: 8x during TSST
Secondary outcomes:
measure: Salivary alpha amylase reactivity to the TSST
timeFrame: 8x during TSST
measure: Sense of Coherence
timeFrame: Baseline, post intervention and follow up
measure: Perceived Stress
timeFrame: Baseline, post intervention and follow up
measure: self efficacy expectancy
timeFrame: Baseline, post intervention and follow up
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University of Zurich
name: Lars B. Sonderegger
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Reinhard Saller, Prof.
role: STUDY_CHAIR
affiliation: University of Zurich
name: Ulrike Ehlert, Prof.
role: STUDY_CHAIR
References: