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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01331577
Acronym
IKSIT
Enrollment
64
Registered
2011-04-08
Start date
2013-12-31
Completion date
2014-09-30
Last updated
2015-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy, Primary Prevention, Stress, Kinesiology, cognitive behavioural therapy, Prevention

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.

Interventions

BEHAVIORALCognitive Behavioural Training

Two day seminar

BEHAVIORALIntegrative Kinesiology Intervention

Two day seminar

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Area under curve with respect to increase of salivary cortisol titer8x during TSSTTSST 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

MeasureTime frameDescription
Salivary alpha amylase reactivity to the TSST8x during TSSTTSST 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 CoherenceBaseline, post intervention and follow upBaseline: 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 StressBaseline, post intervention and follow upBaseline: 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 expectancyBaseline, post intervention and follow upBaseline: 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)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026