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OpenTrials
Completed

NCT Number: NCT01624168

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.

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Key information

Conditions

Anxiety Anxiety Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Appalachian State University

Boone, North Carolina, 28608, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anxiety Management Education

Behavioral

written materials on management of anxiety for self-study

10 week tai chi intervention

Behavioral

10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week

Enhanced tai chi instruction

Behavioral

10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Primary outcomes

  1. Retention of Randomized Subjects During Intervention

    Time frame: 10 weeks

    Retained subjects are those who are willing to return for complete assessments

  2. Retention of Randomized Subjects for Follow-up

    Time frame: 2 months

    Subjects retained for follow-up are those willing to respond to follow-up assessments

  3. Adherence to Out-of-class Practice

    Time frame: 10 weeks

    Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention

  4. Adherence to Practice After the Intervention

    Time frame: 2 months

    Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.

Secondary outcomes

  1. Change From Baseline in State Anxiety Scores

    Time frame: change from baseline to 4 weeks, 10 weeks, 2 month follow-up

    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.

  2. Change From Baseline in Pittsburgh Sleep Quality Index Scores

    Time frame: baseline, 4 weeks, 10 weeks, 2 month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Appalachian State University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2012
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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