Anxiety
Conditions
Keywords
anxiety, sleep quality, tai chi chuan, young adults
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.
Interventions
BEHAVIORALAnxiety Management Education
written materials on management of anxiety for self-study
BEHAVIORAL10 week tai chi intervention
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week
BEHAVIORALEnhanced tai chi instruction
10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Sponsors
Appalachian State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of Randomized Subjects During Intervention | 10 weeks | Retained subjects are those who are willing to return for complete assessments |
| Retention of Randomized Subjects for Follow-up | 2 months | Subjects retained for follow-up are those willing to respond to follow-up assessments |
| Adherence to Out-of-class Practice | 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 | 2 months | Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in State Anxiety Scores | 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 in Pittsburgh Sleep Quality Index Scores | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anxiety Management Education Anxiety Management Education: written materials on management of anxiety for self-study | 19 |
| 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 | 28 |
| 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 | 28 |
| Total | 75 |
Baseline characteristics
| Characteristic | Anxiety Management Education | 10 Week Tai Chi Intervention | Enhanced Tai Chi Instruction | Total |
|---|---|---|---|---|
| Age, Continuous | 22.42 years STANDARD_DEVIATION 5.47 | 21.21 years STANDARD_DEVIATION 3.04 | 20.18 years STANDARD_DEVIATION 1.16 | 21.13 years STANDARD_DEVIATION 3.5 |
| Sex: Female, Male Female | 14 Participants | 18 Participants | 19 Participants | 51 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 9 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 19 | 9 / 28 | 12 / 28 |
| serious Total, serious adverse events | 0 / 19 | 1 / 28 | 1 / 28 |
Outcome results
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
Time frame: 10 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anxiety Management Education | Adherence to Out-of-class Practice | Adherent to out-of-class practice | NA participants |
| Anxiety Management Education | Adherence to Out-of-class Practice | Not adherent to out-of-class practice | NA participants |
| 10 Week Tai Chi Intervention | Adherence to Out-of-class Practice | Adherent to out-of-class practice | 13 participants |
| 10 Week Tai Chi Intervention | Adherence to Out-of-class Practice | Not adherent to out-of-class practice | 15 participants |
| Enhanced Tai Chi Instruction | Adherence to Out-of-class Practice | Adherent to out-of-class practice | 20 participants |
| Enhanced Tai Chi Instruction | Adherence to Out-of-class Practice | Not adherent to out-of-class practice | 8 participants |
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.
Time frame: 2 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anxiety Management Education | Adherence to Practice After the Intervention | Adherent to practice after the intervention | NA participants |
| Anxiety Management Education | Adherence to Practice After the Intervention | Not adherent to practice after the intervention | NA participants |
| 10 Week Tai Chi Intervention | Adherence to Practice After the Intervention | Adherent to practice after the intervention | 4 participants |
| 10 Week Tai Chi Intervention | Adherence to Practice After the Intervention | Not adherent to practice after the intervention | 24 participants |
| Enhanced Tai Chi Instruction | Adherence to Practice After the Intervention | Adherent to practice after the intervention | 13 participants |
| Enhanced Tai Chi Instruction | Adherence to Practice After the Intervention | Not adherent to practice after the intervention | 15 participants |
Primary
Retention of Randomized Subjects During Intervention
Retained subjects are those who are willing to return for complete assessments
Time frame: 10 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anxiety Management Education | Retention of Randomized Subjects During Intervention | Retained | 17 participants |
| Anxiety Management Education | Retention of Randomized Subjects During Intervention | Not retained | 2 participants |
| 10 Week Tai Chi Intervention | Retention of Randomized Subjects During Intervention | Retained | 22 participants |
| 10 Week Tai Chi Intervention | Retention of Randomized Subjects During Intervention | Not retained | 6 participants |
| Enhanced Tai Chi Instruction | Retention of Randomized Subjects During Intervention | Retained | 25 participants |
| Enhanced Tai Chi Instruction | Retention of Randomized Subjects During Intervention | Not retained | 3 participants |
Primary
Retention of Randomized Subjects for Follow-up
Subjects retained for follow-up are those willing to respond to follow-up assessments
Time frame: 2 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anxiety Management Education | Retention of Randomized Subjects for Follow-up | Retained for follow-up | 15 participants |
| Anxiety Management Education | Retention of Randomized Subjects for Follow-up | Lost to follow-up | 4 participants |
| 10 Week Tai Chi Intervention | Retention of Randomized Subjects for Follow-up | Retained for follow-up | 16 participants |
| 10 Week Tai Chi Intervention | Retention of Randomized Subjects for Follow-up | Lost to follow-up | 12 participants |
| Enhanced Tai Chi Instruction | Retention of Randomized Subjects for Follow-up | Retained for follow-up | 22 participants |
| Enhanced Tai Chi Instruction | Retention of Randomized Subjects for Follow-up | Lost to follow-up | 6 participants |
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.
Time frame: baseline, 4 weeks, 10 weeks, 2 month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anxiety Management Education | Change From Baseline in Pittsburgh Sleep Quality Index Scores | Change from Baseline to 10 weeks | -1.71 units on a scale | Standard Error 0.46 |
| Anxiety Management Education | Change From Baseline in Pittsburgh Sleep Quality Index Scores | Change from Baseline to 4 weeks | -1.06 units on a scale | Standard Error 0.45 |
| Anxiety Management Education | Change From Baseline in Pittsburgh Sleep Quality Index Scores | Change from Baseline to 2 month follow-up | -1.82 units on a scale | Standard Error 0.47 |
| 10 Week Tai Chi Intervention | Change From Baseline in Pittsburgh Sleep Quality Index Scores | Change from Baseline to 10 weeks | -2.98 units on a scale | Standard Error 0.41 |
| 10 Week Tai Chi Intervention | Change From Baseline in Pittsburgh Sleep Quality Index Scores | Change from Baseline to 4 weeks | -1.40 units on a scale | Standard Error 0.39 |
| 10 Week Tai Chi Intervention | Change From Baseline in Pittsburgh Sleep Quality Index Scores | Change from Baseline to 2 month follow-up | -3.60 units on a scale | Standard Error 0.45 |
| Enhanced Tai Chi Instruction | Change From Baseline in Pittsburgh Sleep Quality Index Scores | Change from Baseline to 4 weeks | -1.32 units on a scale | Standard Error 0.36 |
| Enhanced Tai Chi Instruction | Change From Baseline in Pittsburgh Sleep Quality Index Scores | Change from Baseline to 2 month follow-up | -3.05 units on a scale | Standard Error 0.38 |
| Enhanced Tai Chi Instruction | Change From Baseline in Pittsburgh Sleep Quality Index Scores | Change from Baseline to 10 weeks | -2.03 units on a scale | Standard Error 0.38 |
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.
Time frame: change from baseline to 4 weeks, 10 weeks, 2 month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anxiety Management Education | Change From Baseline in State Anxiety Scores | Change from Baseline to 10 weeks | -1.43 units on a scale | Standard Error 2.09 |
| Anxiety Management Education | Change From Baseline in State Anxiety Scores | Change from Baseline to 4 weeks | -1.93 units on a scale | Standard Error 2.06 |
| Anxiety Management Education | Change From Baseline in State Anxiety Scores | Change from Baseline to 2 Month Follow-up | -1.90 units on a scale | Standard Error 2.15 |
| 10 Week Tai Chi Intervention | Change From Baseline in State Anxiety Scores | Change from Baseline to 10 weeks | -4.36 units on a scale | Standard Error 1.89 |
| 10 Week Tai Chi Intervention | Change From Baseline in State Anxiety Scores | Change from Baseline to 4 weeks | -2.70 units on a scale | Standard Error 1.79 |
| 10 Week Tai Chi Intervention | Change From Baseline in State Anxiety Scores | Change from Baseline to 2 Month Follow-up | -5.08 units on a scale | Standard Error 2.03 |
| Enhanced Tai Chi Instruction | Change From Baseline in State Anxiety Scores | Change from Baseline to 4 weeks | -3.17 units on a scale | Standard Error 1.68 |
| Enhanced Tai Chi Instruction | Change From Baseline in State Anxiety Scores | Change from Baseline to 2 Month Follow-up | -3.58 units on a scale | Standard Error 1.78 |
| Enhanced Tai Chi Instruction | Change From Baseline in State Anxiety Scores | Change from Baseline to 10 weeks | -3.04 units on a scale | Standard Error 1.73 |