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

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT01331577

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: Cognitive Behavioural Training Behavioral: Integrative Kinesiology Intervention	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
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)
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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)