Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults

• ClinicalTrials.gov Identifier: NCT01624168
• Recruitment Status: Completed
• First Posted: June 20, 2012
• Results First Posted: September 29, 2015
• Last Update Posted: January 8, 2016
• Sponsor: Appalachian State University
• Information provided by (Responsible Party): Karen Caldwell, Appalachian State University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Anxiety	Behavioral: Anxiety Management Education; Behavioral: 10 week tai chi intervention; Behavioral: Enhanced tai chi instruction	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
• Study Start Date: January 2013
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: August 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Retention of Randomized Subjects During Intervention [ Time Frame: 10 weeks ]
   Retained subjects are those who are willing to return for complete assessments
2. Retention of Randomized Subjects for Follow-up [ Time Frame: 2 months ]
   Subjects retained for follow-up are those willing to respond to follow-up assessments
3. Adherence to Out-of-class Practice [ Time Frame: 10 weeks ]
   Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention
4. Adherence to Practice After the Intervention [ Time Frame: 2 months ]
   Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.

Secondary Outcome Measures :

1. Change From Baseline in State Anxiety Scores [ Time Frame: change from baseline to 4 weeks, 10 weeks, 2 month follow-up ]
   Anxiety was measured by the State Trait Anxiety Inventory - State Scale. Lower scores on this scale reflect better outcomes. Scores can range from 20 to 80.
2. Change From Baseline in Pittsburgh Sleep Quality Index Scores [ Time Frame: baseline, 4 weeks, 10 weeks, 2 month follow-up ]
   Sleep quality was measured by the Pittsburgh Sleep Quality Index Total Score. Lower scores on this scale reflect better outcomes. Scores can range from 0 to 21.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, North Carolina

Appalachian State University

Boone, North Carolina, United States, 28608

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. doi: 10.1080/07448480903540481.

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. doi: 10.1016/j.jbmt.2007.12.001. 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. doi: 10.1089/acm.2010.0645. Epub 2011 Oct 14.

• Responsible Party: Karen Caldwell, Professor, Appalachian State University
• ClinicalTrials.gov Identifier: NCT01624168
• Other Study ID Numbers: EBT Feasibility
• First Posted: June 20, 2012
• Results First Posted: September 29, 2015
• Last Update Posted: January 8, 2016
• Last Verified: January 2016

Keywords provided by Karen Caldwell, Appalachian State University:

anxiety; sleep quality; tai chi chuan; young adults

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders