- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01624168
Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
January 6, 2016 updated by: Karen Caldwell, Appalachian State University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Boone, North Carolina, United States, 28608
- Appalachian State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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
|
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
|
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention of Randomized Subjects During Intervention
Time Frame: 10 weeks
|
Retained subjects are those who are willing to return for complete assessments
|
10 weeks
|
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
|
2 months
|
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
|
10 weeks
|
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.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
change from baseline to 4 weeks, 10 weeks, 2 month follow-up
|
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.
|
baseline, 4 weeks, 10 weeks, 2 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen L. Caldwell, PhD, Appalachian State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
June 15, 2012
First Submitted That Met QC Criteria
June 18, 2012
First Posted (Estimate)
June 20, 2012
Study Record Updates
Last Update Posted (Estimate)
January 8, 2016
Last Update Submitted That Met QC Criteria
January 6, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBT Feasibility
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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