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Clinical Trials/NCT01331577
NCT01331577
Completed
Phase 3

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

University of Zurich1 site in 1 country64 target enrollmentDecember 2013
ConditionsHealthy

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Zurich
Enrollment
64
Locations
1
Primary Endpoint
Area under curve with respect to increase of salivary cortisol titer
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
September 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Area under curve with respect to increase of salivary cortisol titer

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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