Efficacy of Taiji Training as a Program for Stress Prevention

Stress Clinical Trial

Official title:

Efficacy of Taiji Training as a Program for Stress Prevention - a Randomized, Waiting List Controlled Longitudinal Study With Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122706
• Other study ID #: 058/10
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: July 25, 2011
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adult
• Primary Prevention
• Stress
• Tai ji

Intervention

Other:
• Taiji training
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.

Locations

Country	Name	City	State
Switzerland	University of Bern, Institute of Complementary Medicine KIKOM	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Klein PJ, Adams WD. Comprehensive therapeutic benefits of Taiji: a critical review. Am J Phys Med Rehabil. 2004 Sep;83(9):735-45. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) with respect to increase of salivary cortisol titer	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	No
Secondary	salivary alpha amylase reactivity to psychosocial stress		8 times during the Trier Social Stress Test (which lasts 2h)	No
Secondary	heart rate		continuously during the Trier Social Stress Test (which lasts 2h)	No
Secondary	heart rate variability		continuously during the Trier Social Stress Test (which lasts 2h)	No
Secondary	perceived stress	to be measured by using the percieved stress scale (PSS)	before, after the Taiji training and 2 months follow up	No
Secondary	self-efficacy-expectancy	to be measured by using the self-efficacy-expectancy questionnaire (SWE)	before, after the Taiji training and 2 months follow up	No
Secondary	wellbeing	to be measured by using the questionnaire for measuring wellbeing (FEW-16)	before, after the Taiji training and 2 months follow up	No
Secondary	Mindfulness	to be measured by using the Freiburg mindfulness inventory (FMI)	before, after the Taiji training and 2 months follow up	No
Secondary	Self Compassion	to be measured by using the self compassion scale (SCS)	before, after the Taiji training and 2 months follow up	No