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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Lars B. Sonderegger, University of Zurich
ClinicalTrials.gov Identifier:
NCT01331577
First received: April 4, 2011
Last updated: June 12, 2014
Last verified: June 2014

April 4, 2011
June 12, 2014
December 2013
July 2014   (final data collection date for primary outcome measure)
Area under curve with respect to increase of salivary cortisol titer [ Time Frame: 8x during TSST ] [ Designated as safety issue: No ]

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

Same as current
Complete list of historical versions of study NCT01331577 on ClinicalTrials.gov Archive Site
  • Salivary alpha amylase reactivity to the TSST [ Time Frame: 8x during TSST ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, post intervention and follow up ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, post intervention and follow up ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, post intervention and follow up ] [ Designated as safety issue: No ]

    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)

Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Healthy
  • Behavioral: Cognitive Behavioural Training
    Two day seminar
  • Behavioral: Integrative Kinesiology Intervention
    Two day seminar
  • Experimental: Cognitive behavioural Intervention
    Intervention: Behavioral: Cognitive Behavioural Training
  • Experimental: Integrative Kinesiology Intervention
    Intervention: Behavioral: Integrative Kinesiology Intervention
  • No Intervention: Waiting-List control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
64
July 2014
July 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01331577
IKSIT_2011
Not Provided
Lars B. Sonderegger, University of Zurich
University of Zurich
Not Provided
Principal Investigator: Lars B. Sonderegger University of Zurich
Study Chair: Reinhard Saller, Prof. University of Zurich
Study Chair: Ulrike Ehlert, Prof. University of Zurich
University of Zurich
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP