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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Cognitive Behavioural Training; Behavioral: Integrative Kinesiology Intervention

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • University of Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Lars B. Sonderegger, University of Zurich; Study Chair: Reinhard Saller, Prof., University of Zurich; Study Chair: Ulrike Ehlert, Prof., University of Zurich

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 6, 2011
• First Posted (Estimate): April 8, 2011

Study Record Updates

• Last Update Posted (Estimate): November 5, 2015
• Last Update Submitted That Met QC Criteria: November 4, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Stress; Healthy; Prevention; cognitive behavioural therapy; Primary Prevention; Kinesiology
• Other Study ID Numbers: IKSIT_2011