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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Caldwell, Appalachian State University
ClinicalTrials.gov Identifier:
NCT01624168
First received: June 15, 2012
Last updated: January 6, 2016
Last verified: January 2016
Results First Received: August 31, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anxiety
Interventions: Behavioral: Anxiety Management Education
Behavioral: 10 week tai chi intervention
Behavioral: Enhanced tai chi instruction

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Anxiety Management Education Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention

10 week course in Evidence Based Tai Chi meeting 2 times per week

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

Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice


Participant Flow:   Overall Study
    Anxiety Management Education     10 Week Tai Chi Intervention     Enhanced Tai Chi Instruction  
STARTED     19     28     28  
COMPLETED     15     16     22  
NOT COMPLETED     4     12     6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Anxiety Management Education Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention

10 week course in Evidence Based Tai Chi meeting 2 times per week

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

Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Total Total of all reporting groups

Baseline Measures
    Anxiety Management Education     10 Week Tai Chi Intervention     Enhanced Tai Chi Instruction     Total  
Number of Participants  
[units: participants]
  19     28     28     75  
Age  
[units: years]
Mean (Standard Deviation)
  22.42  (5.47)     21.21  (3.04)     20.18  (1.16)     21.13  (3.5)  
Gender  
[units: participants]
       
Female     14     18     19     51  
Male     5     10     9     24  



  Outcome Measures
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1.  Primary:   Retention of Randomized Subjects During Intervention   [ Time Frame: 10 weeks ]

2.  Primary:   Retention of Randomized Subjects for Follow-up   [ Time Frame: 2 months ]

3.  Primary:   Adherence to Out-of-class Practice   [ Time Frame: 10 weeks ]

4.  Primary:   Adherence to Practice After the Intervention   [ Time Frame: 2 months ]

5.  Secondary:   Change From Baseline in State Anxiety Scores   [ Time Frame: change from baseline to 4 weeks, 10 weeks, 2 month follow-up ]

6.  Secondary:   Change From Baseline in Pittsburgh Sleep Quality Index Scores   [ Time Frame: baseline, 4 weeks, 10 weeks, 2 month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None of the reported Serious Adverse Events or Adverse Events were determined to be a result of participation in the intervention.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Karen Caldwell, Professor
Organization: Appalachian State University
phone: 828-262-6045
e-mail: caldwellkaren@appstate.edu


Publications:

Responsible Party: Karen Caldwell, Appalachian State University
ClinicalTrials.gov Identifier: NCT01624168     History of Changes
Other Study ID Numbers: EBT Feasibility
Study First Received: June 15, 2012
Results First Received: August 31, 2015
Last Updated: January 6, 2016
Health Authority: United States: Institutional Review Board