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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Behavioral: Integrative Kinesiology Intervention; Behavioral: Cognitive Behavioural Training

• Registration Number: NCT01331577
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-08
• Study Start: 2013-12
• Primary Completion: 2014-07
• Study Completion: 2014-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrative Kinesiology Intervention	Integrative Kinesiology Intervention	-
Cognitive behavioural Intervention	Cognitive Behavioural Training	-

Primary Outcome Measures

Name	Time	Method
Area under curve with respect to increase of salivary cortisol titer	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 Outcome Measures

Name	Time	Method
Perceived Stress	Baseline, post intervention and follow up	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)
Sense of Coherence	Baseline, post intervention and follow up	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)
Salivary alpha amylase reactivity to the TSST	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
self efficacy expectancy	Baseline, post intervention and follow up	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)

Trial Locations

Locations (1)

University of Zurich; 🇨🇭 Zurich, Switzerland