Clinical trial NCT01122706: Efficacy of Taiji Training as a Program for Stress Prevention
Official title: Efficacy of Taiji Training as a Program for Stress Prevention - a Randomized, Waiting List Controlled Longitudinal Study With Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention
Stress
Tai ji
Adult
Keywords: tai ji
psychosocial stress
primary prevention
Trier Social Stress Test
salivary cortisol
salivary alpha amylase
heart rate variability
stress management
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2010-05-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve (AUC) with respect to increase of salivary cortisol titer
timeFrame: durring the Trier Social Stress Test
Secondary outcomes:
measure: salivary alpha amylase reactivity to psychosocial stress
timeFrame: 8 times during the Trier Social Stress Test (which lasts 2h)
measure: heart rate
timeFrame: continuously during the Trier Social Stress Test (which lasts 2h)
measure: heart rate variability
timeFrame: continuously during the Trier Social Stress Test (which lasts 2h)
measure: perceived stress
timeFrame: before, after the Taiji training and 2 months follow up
measure: self-efficacy-expectancy
timeFrame: before, after the Taiji training and 2 months follow up
measure: wellbeing
timeFrame: before, after the Taiji training and 2 months follow up
measure: Mindfulness
timeFrame: before, after the Taiji training and 2 months follow up
measure: Self Compassion
timeFrame: before, after the Taiji training and 2 months follow up
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern, Institute of Complementary Medicine KIKOM
Study officials:
affiliation: Institute of Complementary Medicine KIKOM
name: Marko Nedeljkovic, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1176/appi.ajp.160.9.1554.
citation: 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.
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.
citation: 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.
citation: 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.