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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anxiety Management Education | Placebo Comparator |
| |
| 10 week tai chi intervention | Experimental | 10 week course in Evidence Based Tai Chi meeting 2 times per week |
|
| Enhanced tai chi instruction | Experimental | 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anxiety Management Education | Behavioral | written materials on management of anxiety for self-study |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen L. Caldwell, PhD | Appalachian State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Appalachian State University | Boone | North Carolina | 28608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20304755 | Background | 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. | |
| 19329051 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anxiety Management Education | Anxiety Management Education: written materials on management of anxiety for self-study |
| FG001 | 10 Week Tai Chi Intervention | 10 week course in Evidence Based Tai Chi meeting 2 times per week 10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week |
| FG002 | Enhanced Tai Chi Instruction | 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anxiety Management Education | Anxiety Management Education: written materials on management of anxiety for self-study |
| BG001 | 10 Week Tai Chi Intervention | 10 week course in Evidence Based Tai Chi meeting 2 times per week 10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention of Randomized Subjects During Intervention | Retained subjects are those who are willing to return for complete assessments | Posted | Number | participants | 10 weeks |
|
6 months
Participants were asked to complete weekly reports of mood using the Generalized Anxiety Disorder-7 scale and the Patient Health Questionnaire - 2. Participants also were asked about adverse events at 4-week and 10-week laboratory visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anxiety Management Education | Anxiety Management Education: written materials on management of anxiety for self-study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| overdose suicide attempt | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anger | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
None of the reported Serious Adverse Events or Adverse Events were determined to be a result of participation in the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Caldwell, Professor | Appalachian State University | 828-262-6045 | caldwellkaren@appstate.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| 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 |
|
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 |
| 21999153 | Background | 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. |
| BG002 | Enhanced Tai Chi Instruction | 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice |
|
|
| Primary | Retention of Randomized Subjects for Follow-up | Subjects retained for follow-up are those willing to respond to follow-up assessments | Posted | Number | participants | 2 months |
|
|
|
| Primary | 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 | Posted | Number | participants | 10 weeks |
|
|
|
| Primary | 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. | Posted | Number | participants | 2 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | change from baseline to 4 weeks, 10 weeks, 2 month follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | baseline, 4 weeks, 10 weeks, 2 month follow-up |
|
|
|
| 0 |
| 19 |
| 9 |
| 19 |
| EG001 | 10 Week Tai Chi Intervention | 10 week course in Evidence Based Tai Chi meeting 2 times per week 10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week | 1 | 28 | 9 | 28 |
| EG002 | Enhanced Tai Chi Instruction | 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice | 1 | 28 | 12 | 28 |
| Fell on ice, broke ankle | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anxiety with Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cold | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Family Stress | Social circumstances | MedDRA (Unspecified) | Systematic Assessment |
|
| Feeling Blue | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Feeling sick | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Poor sleep | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Worry | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D009422 |
| Nervous System Diseases |
|
| Not adherent to out-of-class practice |
|
| Not adherent to practice after the intervention |
|
|
| Change from Baseline to 2 Month Follow-up |
|
|
| Change from Baseline to 2 month follow-up |
|