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Completed

NCT Number: NCT01331577

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Behavioural Training

Behavioral

Two day seminar

Integrative Kinesiology Intervention

Behavioral

Two day seminar

Primary outcomes

  1. Area under curve with respect to increase of salivary cortisol titer

    Time frame: 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 outcomes

  1. Salivary alpha amylase reactivity to the TSST

    Time frame: 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

  2. Sense of Coherence

    Time frame: 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)

  3. Perceived Stress

    Time frame: 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)

  4. self efficacy expectancy

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: IKSIT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2011
Registry last updated
Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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