Trial Outcomes & Findings for Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults (NCT NCT01624168)
NCT ID: NCT01624168
Last Updated: 2016-01-08
Results Overview
Retained subjects are those who are willing to return for complete assessments
COMPLETED
NA
75 participants
10 weeks
2016-01-08
Participant Flow
Participant milestones
| Measure |
Anxiety Management Education
Anxiety Management Education: written materials on management of anxiety for self-study
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
28
|
28
|
|
Overall Study
COMPLETED
|
15
|
16
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
12
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
Baseline characteristics by cohort
| Measure |
Anxiety Management Education
n=19 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
|
10 Week Tai Chi Intervention
n=28 Participants
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
|
Enhanced Tai Chi Instruction
n=28 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
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.42 years
STANDARD_DEVIATION 5.47 • n=5 Participants
|
21.21 years
STANDARD_DEVIATION 3.04 • n=7 Participants
|
20.18 years
STANDARD_DEVIATION 1.16 • n=5 Participants
|
21.13 years
STANDARD_DEVIATION 3.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 10 weeksRetained subjects are those who are willing to return for complete assessments
Outcome measures
| Measure |
Anxiety Management Education
n=19 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
|
10 Week Tai Chi Intervention
n=28 Participants
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
|
Enhanced Tai Chi Instruction
n=28 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
|
|---|---|---|---|
|
Retention of Randomized Subjects During Intervention
Retained
|
17 participants
|
22 participants
|
25 participants
|
|
Retention of Randomized Subjects During Intervention
Not retained
|
2 participants
|
6 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 2 monthsSubjects retained for follow-up are those willing to respond to follow-up assessments
Outcome measures
| Measure |
Anxiety Management Education
n=19 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
|
10 Week Tai Chi Intervention
n=28 Participants
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
|
Enhanced Tai Chi Instruction
n=28 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
|
|---|---|---|---|
|
Retention of Randomized Subjects for Follow-up
Retained for follow-up
|
15 participants
|
16 participants
|
22 participants
|
|
Retention of Randomized Subjects for Follow-up
Lost to follow-up
|
4 participants
|
12 participants
|
6 participants
|
PRIMARY outcome
Timeframe: 10 weeksSubjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention
Outcome measures
| Measure |
Anxiety Management Education
n=19 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
|
10 Week Tai Chi Intervention
n=28 Participants
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
|
Enhanced Tai Chi Instruction
n=28 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
|
|---|---|---|---|
|
Adherence to Out-of-class Practice
Adherent to out-of-class practice
|
NA participants
Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.
|
13 participants
|
20 participants
|
|
Adherence to Out-of-class Practice
Not adherent to out-of-class practice
|
NA participants
Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.
|
15 participants
|
8 participants
|
PRIMARY outcome
Timeframe: 2 monthsSubjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.
Outcome measures
| Measure |
Anxiety Management Education
n=19 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
|
10 Week Tai Chi Intervention
n=28 Participants
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
|
Enhanced Tai Chi Instruction
n=28 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
|
|---|---|---|---|
|
Adherence to Practice After the Intervention
Not adherent to practice after the intervention
|
NA participants
Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.
|
24 participants
|
15 participants
|
|
Adherence to Practice After the Intervention
Adherent to practice after the intervention
|
NA participants
Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.
|
4 participants
|
13 participants
|
SECONDARY outcome
Timeframe: change from baseline to 4 weeks, 10 weeks, 2 month follow-upAnxiety 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.
Outcome measures
| Measure |
Anxiety Management Education
n=17 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
|
10 Week Tai Chi Intervention
n=22 Participants
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
|
Enhanced Tai Chi Instruction
n=25 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
|
|---|---|---|---|
|
Change From Baseline in State Anxiety Scores
Change from Baseline to 4 weeks
|
-1.93 units on a scale
Standard Error 2.06
|
-2.70 units on a scale
Standard Error 1.79
|
-3.17 units on a scale
Standard Error 1.68
|
|
Change From Baseline in State Anxiety Scores
Change from Baseline to 10 weeks
|
-1.43 units on a scale
Standard Error 2.09
|
-4.36 units on a scale
Standard Error 1.89
|
-3.04 units on a scale
Standard Error 1.73
|
|
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
|
-5.08 units on a scale
Standard Error 2.03
|
-3.58 units on a scale
Standard Error 1.78
|
SECONDARY outcome
Timeframe: baseline, 4 weeks, 10 weeks, 2 month follow-upSleep 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.
Outcome measures
| Measure |
Anxiety Management Education
n=17 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
|
10 Week Tai Chi Intervention
n=22 Participants
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
|
Enhanced Tai Chi Instruction
n=25 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
|
|---|---|---|---|
|
Change From Baseline in Pittsburgh Sleep Quality Index Scores
Change from Baseline to 4 weeks
|
-1.06 units on a scale
Standard Error .45
|
-1.40 units on a scale
Standard Error .39
|
-1.32 units on a scale
Standard Error .36
|
|
Change From Baseline in Pittsburgh Sleep Quality Index Scores
Change from Baseline to 10 weeks
|
-1.71 units on a scale
Standard Error .46
|
-2.98 units on a scale
Standard Error .41
|
-2.03 units on a scale
Standard Error .38
|
|
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 .47
|
-3.60 units on a scale
Standard Error .45
|
-3.05 units on a scale
Standard Error .38
|
Adverse Events
Anxiety Management Education
10 Week Tai Chi Intervention
Enhanced Tai Chi Instruction
Serious adverse events
| Measure |
Anxiety Management Education
n=19 participants at risk
Anxiety Management Education: written materials on management of anxiety for self-study
|
10 Week Tai Chi Intervention
n=28 participants at risk
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
|
Enhanced Tai Chi Instruction
n=28 participants at risk
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
|
|---|---|---|---|
|
Psychiatric disorders
overdose suicide attempt
|
0.00%
0/19 • 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.
|
0.00%
0/28 • 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.
|
3.6%
1/28 • 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.
|
|
Musculoskeletal and connective tissue disorders
Fell on ice, broke ankle
|
0.00%
0/19 • 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.
|
3.6%
1/28 • 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.
|
0.00%
0/28 • 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.
|
Other adverse events
| Measure |
Anxiety Management Education
n=19 participants at risk
Anxiety Management Education: written materials on management of anxiety for self-study
|
10 Week Tai Chi Intervention
n=28 participants at risk
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
|
Enhanced Tai Chi Instruction
n=28 participants at risk
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
|
|---|---|---|---|
|
Psychiatric disorders
Anger
|
5.3%
1/19 • 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.
|
0.00%
0/28 • 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.
|
0.00%
0/28 • 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.
|
|
Psychiatric disorders
Anxiety
|
15.8%
3/19 • 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.
|
3.6%
1/28 • 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.
|
10.7%
3/28 • 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.
|
|
Psychiatric disorders
Anxiety with Depression
|
10.5%
2/19 • 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.
|
3.6%
1/28 • 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.
|
3.6%
1/28 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
5.3%
1/19 • 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.
|
17.9%
5/28 • 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.
|
17.9%
5/28 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • 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.
|
0.00%
0/28 • 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.
|
7.1%
2/28 • 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.
|
|
Social circumstances
Family Stress
|
10.5%
2/19 • 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.
|
0.00%
0/28 • 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.
|
3.6%
1/28 • 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.
|
|
Psychiatric disorders
Feeling Blue
|
0.00%
0/19 • 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.
|
7.1%
2/28 • 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.
|
14.3%
4/28 • 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.
|
|
General disorders
Feeling sick
|
0.00%
0/19 • 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.
|
7.1%
2/28 • 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.
|
10.7%
3/28 • 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.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
5.3%
1/19 • 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.
|
0.00%
0/28 • 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.
|
3.6%
1/28 • 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.
|
|
Nervous system disorders
Poor sleep
|
5.3%
1/19 • 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.
|
0.00%
0/28 • 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.
|
3.6%
1/28 • 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.
|
|
Psychiatric disorders
Stress
|
5.3%
1/19 • 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.
|
3.6%
1/28 • 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.
|
10.7%
3/28 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • 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.
|
0.00%
0/28 • 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.
|
3.6%
1/28 • 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.
|
|
Psychiatric disorders
Worry
|
10.5%
2/19 • 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.
|
0.00%
0/28 • 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.
|
0.00%
0/28 • 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.
|
Additional Information
Dr. Karen Caldwell, Professor
Appalachian State University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place