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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
  Purpose

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 Intervention Phase
Healthy
Behavioral: Cognitive Behavioural Training
Behavioral: Integrative Kinesiology Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Psychoneuroendocrinological Efficacy Study of an Integrative-kinesiological to a Cognitive-behavioural Intervention With Healthy Individuals

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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)



Estimated Enrollment: 64
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331577

Locations
Switzerland
University of Zurich
Zurich, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Lars B. Sonderegger University of Zurich
Study Chair: Reinhard Saller, Prof. University of Zurich
Study Chair: Ulrike Ehlert, Prof. University of Zurich
  More Information

No publications provided

Responsible Party: Lars B. Sonderegger, Lic. Phil., University of Zurich
ClinicalTrials.gov Identifier: NCT01331577     History of Changes
Other Study ID Numbers: IKSIT_2011
Study First Received: April 4, 2011
Last Updated: June 12, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
Healthy
Primary Prevention
Stress
Kinesiology
cognitive behavioural therapy
Prevention

ClinicalTrials.gov processed this record on November 23, 2014