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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624168
• Other study ID #: EBT Feasibility
• Status: Completed
• Phase: N/A
• First received: June 15, 2012
• Last updated: January 6, 2016
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: January 2016
• Source: Appalachian State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Appalachian State University	Boone	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Appalachian State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of Randomized Subjects During Intervention	Retained subjects are those who are willing to return for complete assessments	10 weeks	No
Primary	Retention of Randomized Subjects for Follow-up	Subjects retained for follow-up are those willing to respond to follow-up assessments	2 months	No
Primary	Adherence to Out-of-class Practice	Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention	10 weeks	No
Primary	Adherence to Practice After the Intervention	Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.	2 months	No
Secondary	Change From Baseline in State Anxiety Scores	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.	change from baseline to 4 weeks, 10 weeks, 2 month follow-up	No
Secondary	Change From Baseline in Pittsburgh Sleep Quality Index Scores	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.	baseline, 4 weeks, 10 weeks, 2 month follow-up	No