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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Karen Caldwell, Appalachian State University
ClinicalTrials.gov Identifier:
NCT01624168
First received: June 15, 2012
Last updated: July 14, 2014
Last verified: July 2014

June 15, 2012
July 14, 2014
January 2013
September 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01624168 on ClinicalTrials.gov Archive Site
  • 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
  • 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, 5 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, 5 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, 5 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, 5 month follow-up ] [ Designated as safety issue: No ]
    change from baseline - salivary cortisol, salivary amylase, heart rate variability
Not Provided
Not Provided
 
Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anxiety
  • Behavioral: Anxiety Management Education
    written materials on management of anxiety for self-study
  • Behavioral: 10 week tai chi intervention
    10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week
  • Behavioral: Enhanced tai chi instruction
    10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
  • Placebo Comparator: Anxiety Management Education
    Intervention: Behavioral: Anxiety Management Education
  • Experimental: 10 week tai chi intervention
    10 week course in Evidence Based Tai Chi meeting 2 times per week
    Intervention: Behavioral: 10 week tai chi intervention
  • Experimental: Enhanced tai chi instruction
    10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
    Intervention: Behavioral: Enhanced tai chi instruction

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01624168
EBT Feasibility
Yes
Karen Caldwell, Appalachian State University
Appalachian State University
Not Provided
Principal Investigator: Karen L. Caldwell, PhD Appalachian State University
Appalachian State University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP