AnxietyNCT01624168
Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
A study testing Anxiety Management Education, 10 week tai chi intervention and Enhanced tai chi instruction in people with Anxiety, run by Appalachian State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Anxiety Management Education, 10 week tai chi intervention and Enhanced tai chi instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Appalachian State University
Boone, North Carolina, 28608
About this study
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.
- Conditions
- Anxiety
- Being tested
- Anxiety Management Education, 10 week tai chi intervention, Enhanced tai chi instruction
- Keywords
- anxiety, sleep quality, tai chi chuan, young adults
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety Management EducationBehavioural
written materials on management of anxiety for self-study
10 week tai chi interventionBehavioural
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week
Enhanced tai chi instructionBehavioural
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
| Study group | Role | What they receive |
|---|---|---|
| Anxiety Management Education | Placebo comparator | Not described Receives: Behavioral: Anxiety Management Education |
| 10 week tai chi intervention | Experimental | 10 week course in Evidence Based Tai Chi meeting 2 times per week Receives: Behavioral: 10 week tai chi intervention |
| Enhanced tai chi instruction | Experimental | 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice Receives: Behavioral: Enhanced tai chi instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of Randomized Subjects During Intervention
Retained subjects are those who are willing to return for complete assessments
Measured: 10 weeks
Retention of Randomized Subjects for Follow-up
Subjects retained for follow-up are those willing to respond to follow-up assessments
Measured: 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
Measured: 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.
Measured: 2 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: baseline, 4 weeks, 10 weeks, 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Caldwell, Appalachian State University
- Investigators
- Karen L. Caldwell, PhD, Principal investigator, Appalachian State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624168
- Sponsor's protocol ID
- EBT Feasibility
- Status last verified
- Jan 2016
- First submitted
- 15 Jun 2012
- Last updated
- 8 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20304755Caldwell 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.
PubMed 19329051Caldwell 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.
PubMed 21999153
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
- ClinicalTrials.gov ID
- NCT01624168
- Acronym / sponsor ID
- EBT Feasibility
- Conditions
- Anxiety
- Keywords
- anxiety, sleep quality, tai chi chuan, young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Posted 29 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anxiety Management Education | Placebo comparator | Behavioral: Anxiety Management Education |
| 10 week tai chi intervention | Experimental | Behavioral: 10 week tai chi intervention10 week course in Evidence Based Tai Chi meeting 2 times per week |
| Enhanced tai chi instruction | Experimental | Behavioral: Enhanced tai chi instruction10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anxiety Management Educationwritten materials on management of anxiety for self-study | Behavioural | Anxiety Management Education |
| 10 week tai chi intervention10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week | Behavioural | 10 week tai chi intervention |
| Enhanced tai chi instruction10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice | Behavioural | Enhanced tai chi instruction |
Primary outcome
Retention of Randomized Subjects During Intervention
Time frame: 10 weeks
Retained subjects are those who are willing to return for complete assessments
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
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
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 secondary outcomes
Change From Baseline in State Anxiety Scores
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20304755Caldwell 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.
- Background: PubMed 19329051Caldwell 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.
- Background: PubMed 21999153Caldwell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen L. Caldwell, PhD principal investigator
Appalachian State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety Management Education, 10 week tai chi intervention and Enhanced tai chi instruction in people with Anxiety, run by Appalachian State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of Randomized Subjects During Intervention (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01624168, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.