Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Jan 2013
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
September 29, 2015
CompletedJanuary 8, 2016
January 1, 2016
1.4 years
June 15, 2012
August 31, 2015
January 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Retention of Randomized Subjects During Intervention
Retained subjects are those who are willing to return for complete assessments
10 weeks
Retention of Randomized Subjects for Follow-up
Subjects retained for follow-up are those willing to respond to follow-up assessments
2 months
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
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
Secondary Outcomes (2)
Change From Baseline in State Anxiety Scores
change from baseline to 4 weeks, 10 weeks, 2 month follow-up
Change From Baseline in Pittsburgh Sleep Quality Index Scores
baseline, 4 weeks, 10 weeks, 2 month follow-up
Study Arms (3)
Anxiety Management Education
PLACEBO COMPARATOR10 week tai chi intervention
EXPERIMENTAL10 week course in Evidence Based Tai Chi meeting 2 times per week
Enhanced tai chi instruction
EXPERIMENTAL10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Interventions
written materials on management of anxiety for self-study
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Appalachian State University
Boone, North Carolina, 28608, United States
Related Publications (3)
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.
PMID: 20304755BACKGROUNDCaldwell 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.
PMID: 19329051BACKGROUNDCaldwell 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.
PMID: 21999153BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
None of the reported Serious Adverse Events or Adverse Events were determined to be a result of participation in the intervention.
Results Point of Contact
- Title
- Dr. Karen Caldwell, Professor
- Organization
- Appalachian State University
Study Officials
- PRINCIPAL INVESTIGATOR
Karen L. Caldwell, PhD
Appalachian State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 15, 2012
First Posted
June 20, 2012
Study Start
January 1, 2013
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
January 8, 2016
Results First Posted
September 29, 2015
Record last verified: 2016-01