Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Purpose
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.

Condition Intervention
Anxiety
Behavioral: Anxiety Management Education
Behavioral: 10 week tai chi intervention
Behavioral: Enhanced tai chi instruction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults

Resource links provided by NLM:


Further study details as provided by Appalachian State University:

Primary Outcome Measures:
  • Retention of Randomized Subjects During Intervention [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Retained subjects are those who are willing to return for complete assessments

  • Retention of Randomized Subjects for Follow-up [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Subjects retained for follow-up are those willing to respond to follow-up assessments

  • Adherence to Out-of-class Practice [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: change from baseline to 4 weeks, 10 weeks, 2 month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 4 weeks, 10 weeks, 2 month follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 75
Study Start Date: January 2013
Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Anxiety Management Education Behavioral: 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
Behavioral: 10 week tai chi intervention
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
Behavioral: Enhanced tai chi instruction
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624168

Locations
United States, North Carolina
Appalachian State University
Boone, North Carolina, United States, 28608
Sponsors and Collaborators
Appalachian State University
Investigators
Principal Investigator: Karen L. Caldwell, PhD Appalachian State University
  More Information

Publications:
Responsible Party: Karen Caldwell, Professor, 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

Keywords provided by Appalachian State University:
anxiety
sleep quality
tai chi chuan
young adults

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016