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

January 6, 2016 updated by: Karen Caldwell, Appalachian State University
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Boone, North Carolina, United States, 28608
        • Appalachian State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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
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
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention of Randomized Subjects During Intervention
Time Frame: 10 weeks
Retained subjects are those who are willing to return for complete assessments
10 weeks
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
2 months
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
10 weeks
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.
2 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karen L. Caldwell, PhD, Appalachian State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBT Feasibility

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on Anxiety Management Education

3
Subscribe