- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01122706
Efficacy of Taiji Training as a Program for Stress Prevention
Efficacy of Taiji Training as a Program for Stress Prevention - a Randomized, Waiting List Controlled Longitudinal Study With Healthy Subjects
Background: Excessive exposure to psychosocial stress can be a potent trigger for somatic diseases and psychological disorders, a cause for missing work, and eventually lead to high economic loss. Therefore, for health and economic reasons the assessment of effectiveness of stress preventive interventions is of high relevance. According to several clinical studies, Taiji, a Chinese form of mindful and gentle movements, can significantly reduce symptoms of somatic diseases and psychological disorders. Some recently conducted Taiji-studies with healthy subjects indicate a stress protective effect. However, the stress protective impact of Taiji regarding psychosocial stress has not yet been examined.
Objective: To investigate the efficacy of a 12 week Taiji training as a stress prevention program by measuring psychosocial stress reactivity in a laboratory setting, as well as the subjective perception of stress and coping-resources in daily life of 70 healthy volunteers.
Hypothesis: Healthy subjects attending a 12 week Taiji course (frequency: twice a week for 1h) will show significantly reduced psychobiological reactivity, decreased stress perception and increased coping-resources on a standardized psychosocial stress test compared with healthy subject of the waiting list.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Excessive exposure to psychosocial stress can be a potent trigger for somatic diseases and psychological disorders, a cause for missing work, and eventually lead to high economic loss. Therefore, for health and economic reasons the assessment of effectiveness of stress preventive interventions is of high relevance. According to several clinical studies, Taiji, a Chinese form of mindful and gentle movements, can significantly reduce symptoms of somatic diseases and psychological disorders. Some recent Taiji-studies with healthy subjects indicate a stress protective effect. However, since these findings mainly focus on effects during or immediately after a Taiji training session, their study designs and outcome measures are not comparable with existing stress prevention efficacy studies and their sample sizes are generally too small, the present available results remain inconclusive. Also, the impact of a Taiji training on psychosocial stress has not been assessed so far.
Objective:
The objective of this study is to assess the efficacy of a 12 week Taiji training as a stress prevention program by measuring psychosocial stress reactivity in a laboratory setting, subjective perception of stress and coping-resources of 70 healthy subjects in daily life.
Methods:
The Trier Social Stress Test (TSST) will be used to measure the psychobiological stress reactivity. Salivary cortisol, alpha amylase, heart rate and heart rate variability will be measured in each subject to asses stress reactivity, Also, the primary appraisal secondary appraisal (PASA) questionnaire and the multidimensional mood questionnaire (MDBF) will be used to assess psychological stress reactivity, and a visual analogue scale (VAS) to measure perceived stressfulness.
Additionally to the TSST setting, pre-, post-intervention and 2 months follow up measurements will be taken. The following tools will be used: Perceived Stress Scale (PSS), Stress Reactivity Scale (SRS)(to assess perceived stress), and self-efficacy-expectancy questionnaire (SWE), questionnaire for measuring wellbeing (FEW-16), Freiburg mindfulness inventory (FMI) and self compassion scale (SCS) (to assess perceived coping resources).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, 3010
- University of Bern, Institute of Complementary Medicine KIKOM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ready to participate in the Taiji-intervention group as well as in the Waiting list control group
- mentally healthy
- physically healthy
- fluent in German (written and spoken)
Exclusion Criteria
- previous practical experience with Taiji-exercises
- previous practical experience with the Trier Social Stress Test
- being absent for more than one week between Sept. 6th and Nov. 25th 2010
- daily alcohol consumption more than two alcoholic drinks
- daily tobacco consumption more than five cigarettes per day
- any kind of drug consumption
- pregnancy
- intake of hormonal compounds i.e. birth control pill and hormon replacement therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Taiji
35 healthy participants will regularly during 12 weeks attend Taiji training classes twice a week for one hour.
(Sept.
6th till Nov. 25th 2010).
|
Taiji training during 12 weeks (twice a week for 1 hour) (Sept.
6th till Nov. 25th 2010).
The first 18 sequences of a series of 37 movements of the short form Yang style Taiji will be taught.
The focus will be on memorizing the series of movements, developing a regular training routine and working on body alignment and flow of the movements.
Other Names:
|
No Intervention: waiting list control group
35 healthy participants are not allowed to attend any Taiji training during the intervention period (Sept.
6th till Nov. 25th 2010).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve (AUC) with respect to increase of salivary cortisol titer
Time Frame: durring the Trier Social Stress Test
|
saliva samples will be taken 8 times during the Trier Social Stresstest.
Salivary cortisol reactivity in response to this psychosocial stress test will be calculated by aggregating cortisol data of all 8 saliva samples in an AUC value with respect to increase.
|
durring the Trier Social Stress Test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
salivary alpha amylase reactivity to psychosocial stress
Time Frame: 8 times during the Trier Social Stress Test (which lasts 2h)
|
8 times during the Trier Social Stress Test (which lasts 2h)
|
|
heart rate
Time Frame: continuously during the Trier Social Stress Test (which lasts 2h)
|
continuously during the Trier Social Stress Test (which lasts 2h)
|
|
heart rate variability
Time Frame: continuously during the Trier Social Stress Test (which lasts 2h)
|
continuously during the Trier Social Stress Test (which lasts 2h)
|
|
perceived stress
Time Frame: before, after the Taiji training and 2 months follow up
|
to be measured by using the percieved stress scale (PSS)
|
before, after the Taiji training and 2 months follow up
|
self-efficacy-expectancy
Time Frame: before, after the Taiji training and 2 months follow up
|
to be measured by using the self-efficacy-expectancy questionnaire (SWE)
|
before, after the Taiji training and 2 months follow up
|
wellbeing
Time Frame: before, after the Taiji training and 2 months follow up
|
to be measured by using the questionnaire for measuring wellbeing (FEW-16)
|
before, after the Taiji training and 2 months follow up
|
Mindfulness
Time Frame: before, after the Taiji training and 2 months follow up
|
to be measured by using the Freiburg mindfulness inventory (FMI)
|
before, after the Taiji training and 2 months follow up
|
Self Compassion
Time Frame: before, after the Taiji training and 2 months follow up
|
to be measured by using the self compassion scale (SCS)
|
before, after the Taiji training and 2 months follow up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marko Nedeljkovic, MSc, Institute of Complementary Medicine KIKOM
Publications and helpful links
General Publications
- Figueredo VM. The time has come for physicians to take notice: the impact of psychosocial stressors on the heart. Am J Med. 2009 Aug;122(8):704-12. doi: 10.1016/j.amjmed.2009.05.001.
- Raison CL, Miller AH. When not enough is too much: the role of insufficient glucocorticoid signaling in the pathophysiology of stress-related disorders. Am J Psychiatry. 2003 Sep;160(9):1554-65. doi: 10.1176/appi.ajp.160.9.1554.
- Klein PJ, Adams WD. Comprehensive therapeutic benefits of Taiji: a critical review. Am J Phys Med Rehabil. 2004 Sep;83(9):735-45. doi: 10.1097/01.phm.0000137317.98890.74.
- Esch T, Duckstein J, Welke J, Braun V. Mind/body techniques for physiological and psychological stress reduction: stress management via Tai Chi training - a pilot study. Med Sci Monit. 2007 Nov;13(11):CR488-497.
- Dickerson SS, Kemeny ME. Acute stressors and cortisol responses: a theoretical integration and synthesis of laboratory research. Psychol Bull. 2004 May;130(3):355-91. doi: 10.1037/0033-2909.130.3.355.
- Nedeljkovic M, Ausfeld-Hafter B, Streitberger K, Seiler R, Wirtz PH. Taiji practice attenuates psychobiological stress reactivity--a randomized controlled trial in healthy subjects. Psychoneuroendocrinology. 2012 Aug;37(8):1171-80. doi: 10.1016/j.psyneuen.2011.12.007. Epub 2012 Jan 4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 058/10
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