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

Study Overview
=================
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.

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

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: Anxiety Management Education
* Behavioral: 10 week tai chi intervention
* Behavioral: Enhanced tai chi instruction


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Anxiety Management Education<br> | Behavioral: Anxiety Management Education<br>* written materials on management of anxiety for self-study<br>|
| Experimental: 10 week tai chi intervention<br>10 week course in Evidence Based Tai Chi meeting 2 times per week | Behavioral: 10 week tai chi intervention<br>* 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week<br>|
| Experimental: Enhanced tai chi instruction<br>10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice | Behavioral: Enhanced tai chi instruction<br>* 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of Randomized Subjects During Intervention | Retained subjects are those who are willing to return for complete assessments | 10 weeks | 
| Retention of Randomized Subjects for Follow-up | Subjects retained for follow-up are those willing to respond to follow-up assessments | 2 months | 
| 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 | 10 weeks | 
| 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 to 4 weeks, 10 weeks, 2 month follow-up | 
| 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. | baseline, 4 weeks, 10 weeks, 2 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, sleep quality, tai chi chuan, young adults