Back to resultsEffects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anxiety Management Education
10 week tai chi intervention
Enhanced tai chi instruction
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring anxiety, sleep quality, tai chi chuan, young adults
Eligibility 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
Sites / Locations
- Appalachian State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Anxiety Management Education
10 week tai chi intervention
Enhanced tai chi instruction
Arm Description
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 plus DVD for home practice
Outcomes
Primary Outcome Measures
Retention of Randomized Subjects During Intervention
Retained subjects are those who are willing to return for complete assessments
Retention of Randomized Subjects for Follow-up
Subjects retained for follow-up are those willing to respond to follow-up assessments
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
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.
Secondary Outcome Measures
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 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.
Full Information
NCT ID
NCT01624168
First Posted
June 15, 2012
Last Updated
January 6, 2016
Sponsor
Appalachian State University
1. Study Identification
Unique Protocol Identification Number
NCT01624168
Brief Title
Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
Official Title
Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Appalachian State University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, sleep quality, tai chi chuan, young adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anxiety Management Education
Arm Type
Placebo Comparator
Arm Title
10 week tai chi intervention
Arm Type
Experimental
Arm Description
10 week course in Evidence Based Tai Chi meeting 2 times per week
Arm Title
Enhanced tai chi instruction
Arm Type
Experimental
Arm Description
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Intervention Type
Behavioral
Intervention Name(s)
Anxiety Management Education
Intervention Description
written materials on management of anxiety for self-study
Intervention Type
Behavioral
Intervention Name(s)
10 week tai chi intervention
Intervention Description
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week
Intervention Type
Behavioral
Intervention Name(s)
Enhanced tai chi instruction
Intervention Description
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Primary Outcome Measure Information:
Title
Retention of Randomized Subjects During Intervention
Description
Retained subjects are those who are willing to return for complete assessments
Time Frame
10 weeks
Title
Retention of Randomized Subjects for Follow-up
Description
Subjects retained for follow-up are those willing to respond to follow-up assessments
Time Frame
2 months
Title
Adherence to Out-of-class Practice
Description
Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention
Time Frame
10 weeks
Title
Adherence to Practice After the Intervention
Description
Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change From Baseline in State Anxiety Scores
Description
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.
Time Frame
change from baseline to 4 weeks, 10 weeks, 2 month follow-up
Title
Change From Baseline in Pittsburgh Sleep Quality Index Scores
Description
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.
Time Frame
baseline, 4 weeks, 10 weeks, 2 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen L. Caldwell, PhD
Organizational Affiliation
Appalachian State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Appalachian State University
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28608
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20304755
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.
Results Reference
background
PubMed Identifier
19329051
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.
Results Reference
background
PubMed Identifier
21999153
Citation
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.
Results Reference
background
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Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
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