Clinical trial NCT01624168: Effects of Tai Chi Chuan on Psychobiological Indicators of 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: anxiety
sleep quality
tai chi chuan
young adults
Lead sponsor: Appalachian State University
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Retention of Randomized Subjects During Intervention
timeFrame: 10 weeks
measure: Retention of Randomized Subjects for Follow-up
timeFrame: 2 months
measure: Adherence to Out-of-class Practice
timeFrame: 10 weeks
measure: Adherence to Practice After the Intervention
timeFrame: 2 months
Secondary outcomes:
measure: Change From Baseline in State Anxiety Scores
timeFrame: change from baseline to 4 weeks, 10 weeks, 2 month follow-up
measure: Change From Baseline in Pittsburgh Sleep Quality Index Scores
timeFrame: baseline, 4 weeks, 10 weeks, 2 month follow-up
Other outcomes:
Locations:
city: Boone
country: United States
facility: Appalachian State University
state: North Carolina
Study officials:
affiliation: Appalachian State University
name: Karen L. Caldwell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caldwell K, Harrison M, Adams M, Quin RH, Greeson J. Developing mindfulness in college students through movement-based courses: effects on self-regulatory self-efficacy, mood, stress, and sleep quality. J Am Coll Health. 2010 Mar-Apr;58(5):433-42. doi: 10.1080/07448480903540481.
citation: Caldwell K, Harrison M, Adams M, Triplett NT. Effect of Pilates and taiji quan training on self-efficacy, sleep quality, mood, and physical performance of college students. J Bodyw Mov Ther. 2009 Apr;13(2):155-63. doi: 10.1016/j.jbmt.2007.12.001. Epub 2008 Feb 20.
citation: Caldwell K, Emery L, Harrison M, Greeson J. Changes in mindfulness, well-being, and sleep quality in college students through taijiquan courses: a cohort control study. J Altern Complement Med. 2011 Oct;17(10):931-8. doi: 10.1089/acm.2010.0645. Epub 2011 Oct 14.