NCT01331577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_3 healthy

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
2.7 years until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 5, 2015

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

April 4, 2011

Last Update Submit

November 4, 2015

Conditions

Healthy

Keywords

HealthyPrimary PreventionStressKinesiologycognitive behavioural therapyPrevention

Outcome Measures

Primary Outcomes (1)

  • Area under curve with respect to increase of salivary cortisol titer

    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

    8x during TSST

Secondary Outcomes (4)

  • Salivary alpha amylase reactivity to the TSST

    8x during TSST

  • Sense of Coherence

    Baseline, post intervention and follow up

  • Perceived Stress

    Baseline, post intervention and follow up

  • self efficacy expectancy

    Baseline, post intervention and follow up

Study Arms (3)

Cognitive behavioural Intervention

EXPERIMENTAL
Behavioral: Cognitive Behavioural Training

Integrative Kinesiology Intervention

EXPERIMENTAL
Behavioral: Integrative Kinesiology Intervention

Waiting-List control group

NO INTERVENTION

Interventions

Cognitive Behavioural TrainingBEHAVIORAL

Two day seminar

Cognitive behavioural Intervention
Integrative Kinesiology InterventionBEHAVIORAL

Two day seminar

Integrative Kinesiology Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ready to participate in randomly one of the three groups
  • mentally and physically healthy
  • Sufficient German-speaking abilities to participate in the training

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Location

Study Officials

  • Lars B. Sonderegger

    University of Zurich

    PRINCIPAL INVESTIGATOR

  • Reinhard Saller, Prof.

    University of Zurich

    STUDY CHAIR

  • Ulrike Ehlert, Prof.

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 8, 2011

Study Start

December 1, 2013

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

November 5, 2015

Record last verified: 2015-10

Locations

CH(1)