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

This study is currently recruiting participants.
Verified October 2013 by Appalachian State University
Sponsor:
Information provided by (Responsible Party):
Karen Caldwell, Appalachian State University
ClinicalTrials.gov Identifier:
NCT01624168
First received: June 15, 2012
Last updated: October 7, 2013
Last verified: October 2013
  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:
  • Collect preliminary data on the relationship between tai chi chuan practice and changes in symptoms of anxiety to aid in future study planning. [ Time Frame: change from baseline to 4 weeks, 10 weeks, 2 month follow-up ] [ Designated as safety issue: No ]
    Anxiety will be measured by the State Trait Anxiety Inventory.

  • Collect preliminary data on the relationship between tai chi chuan practice and changes in symptoms of sleep quality to aid in future study planning. [ Time Frame: baseline, 4 weeks, 10 weeks, 2 month follow-up ] [ Designated as safety issue: No ]
    change from baseline - sleep quality as measured by the Pittsburgh Sleep Quality Index and ambulatory EEG

  • Collect preliminary data on the relationship between tai chi chuan practice and changes in psychological functioning to aid in future study planning. [ Time Frame: baseline, 4 weeks, 10 weeks, 2 month follow-up ] [ Designated as safety issue: No ]
    change from baseline - mindfulness, acceptance, thought control

  • Collect preliminary data on the relationship between tai chi chuan practice and changes in physiological arousal to aid in future study planning. [ Time Frame: baseline, 4 weeks, 10 weeks, 2 month follow-up ] [ Designated as safety issue: No ]
    change from baseline - salivary cortisol, salivary amylase, heart rate variability


Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624168

Contacts
Contact: Karen L. Caldwell, PhD 828-262-6045 caldwllkl@appstate.edu

Locations
United States, North Carolina
Appalachian State University Recruiting
Boone, North Carolina, United States, 28608
Contact: Karen L. Caldwell, PhD    828-262-6045    caldwllkl@appstate.edu   
Contact: Rebecca Quin, MA    828-262-7611    hower@appstate.edu   
Principal Investigator: Karen L. Caldwell, PhD         
Sponsors and Collaborators
Appalachian State University
Investigators
Principal Investigator: Karen L. Caldwell, PhD Appalachian State University
  More Information