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

Healthy Clinical Trial

— IKSIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331577
• Other study ID #: IKSIT_2011
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2011
• Last updated: November 4, 2015
• Start date: December 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Cognitive Behavioural Training
Two day seminar
• Integrative Kinesiology Intervention
Two day seminar

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No