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

NCT ID: NCT01331577

Last Updated: 2015-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cognitive behavioural Intervention

Group Type EXPERIMENTAL

Cognitive Behavioural Training

Intervention Type BEHAVIORAL

Two day seminar

Integrative Kinesiology Intervention

Group Type EXPERIMENTAL

Integrative Kinesiology Intervention

Intervention Type BEHAVIORAL

Two day seminar

Waiting-List control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioural Training

Two day seminar

Intervention Type BEHAVIORAL

Integrative Kinesiology Intervention

Two day seminar

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars B. Sonderegger

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Reinhard Saller, Prof.

Role: STUDY_CHAIR

University of Zurich

Ulrike Ehlert, Prof.

Role: STUDY_CHAIR

University of Zurich

Locations

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University of Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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IKSIT_2011

Identifier Type: -

Identifier Source: org_study_id

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