Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults - Full Text View

Purpose

The purpose of this study is to determine the feasibility of a 10-week tai chi chuan intervention as a treatment for anxiety and sleep quality in young adults.

Condition	Intervention
Anxiety	Behavioral: Anxiety Management Education Behavioral: 10 week tai chi intervention Behavioral: Enhanced tai chi instruction

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by Appalachian State University:

Primary Outcome Measures:

Retention of randomized subjects during intervention [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Retained subjects are those who are willing to return for complete assessments
Retention of randomized subjects for follow-up [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Subjects retained for follow-up are those willing to respond to follow-up assessments
Adherence to out-of-class practice [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention
Adherence to practice after the intervention [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.

Secondary Outcome Measures:

Collect preliminary data on the relationship between tai chi chuan practice and changes in symptoms of anxiety to aid in future study planning. [ Time Frame: change from baseline to 4 weeks, 10 weeks, 2 month follow-up ] [ Designated as safety issue: No ]
Anxiety will be measured by the State Trait Anxiety Inventory.
Collect preliminary data on the relationship between tai chi chuan practice and changes in symptoms of sleep quality to aid in future study planning. [ Time Frame: baseline, 4 weeks, 10 weeks, 2 month follow-up ] [ Designated as safety issue: No ]
change from baseline - sleep quality as measured by the Pittsburgh Sleep Quality Index and ambulatory EEG
Collect preliminary data on the relationship between tai chi chuan practice and changes in psychological functioning to aid in future study planning. [ Time Frame: baseline, 4 weeks, 10 weeks, 2 month follow-up ] [ Designated as safety issue: No ]
change from baseline - mindfulness, acceptance, thought control
Collect preliminary data on the relationship between tai chi chuan practice and changes in physiological arousal to aid in future study planning. [ Time Frame: baseline, 4 weeks, 10 weeks, 2 month follow-up ] [ Designated as safety issue: No ]
change from baseline - salivary cortisol, salivary amylase, heart rate variability

Estimated Enrollment:	80
Study Start Date:	January 2013
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Anxiety Management Education	Behavioral: Anxiety Management Education written materials on management of anxiety for self-study
Experimental: 10 week tai chi intervention 10 week course in Evidence Based Tai Chi meeting 2 times per week	Behavioral: 10 week tai chi intervention 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week
Experimental: Enhanced tai chi instruction 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice	Behavioral: Enhanced tai chi instruction 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

mild to severe symptoms of anxiety
interest in participating in an exercise intervention
willingness to accept randomization
provides informed consent
low or moderate risk for acute cardiovascular event

Exclusion Criteria:

currently receiving psychotherapy or medication for psychological problems
current suicide or homicide risk
current or history of psychosis
current alcohol or substance dependence
high risk for an acute cardiovascular event
current use of prescription drugs with potential to influence the parasympathetic or sympathetic nervous system
current or previous extensive involvement in mind-body exercise
symptoms of severe depression

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624168

Contacts

Contact: Karen L. Caldwell, PhD

828-262-6045

caldwllkl@appstate.edu

Locations

United States, North Carolina
Appalachian State University	Recruiting
Boone, North Carolina, United States, 28608
Contact: Karen L. Caldwell, PhD 828-262-6045 caldwllkl@appstate.edu
Contact: Rebecca Quin, MA 828-262-7611 hower@appstate.edu
Principal Investigator: Karen L. Caldwell, PhD

Sponsors and Collaborators

Appalachian State University

Investigators

Principal Investigator:

Karen L. Caldwell, PhD

Appalachian State University

More Information

Publications:

Caldwell K, Harrison M, Adams M, Quin RH, Greeson J. Developing mindfulness in college students through movement-based courses: effects on self-regulatory self-efficacy, mood, stress, and sleep quality. J Am Coll Health. 2010 Mar-Apr;58(5):433-42.

Caldwell K, Harrison M, Adams M, Triplett NT. Effect of Pilates and taiji quan training on self-efficacy, sleep quality, mood, and physical performance of college students. J Bodyw Mov Ther. 2009 Apr;13(2):155-63. Epub 2008 Feb 20.

Caldwell K, Emery L, Harrison M, Greeson J. Changes in mindfulness, well-being, and sleep quality in college students through taijiquan courses: a cohort control study. J Altern Complement Med. 2011 Oct;17(10):931-8. Epub 2011 Oct 14.

Responsible Party:	Karen Caldwell, Professor, Appalachian State University
ClinicalTrials.gov Identifier:	NCT01624168 History of Changes
Other Study ID Numbers:	EBT Feasibility
Study First Received:	June 15, 2012
Last Updated:	January 7, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Appalachian State University:

anxiety
sleep quality
tai chi chuan
young adults

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013