Trial Outcomes & Findings for Comparing Effects of a Holistic Yoga Program and a Wellness Program on PTSD Symptoms (NCT NCT02234622)
NCT ID: NCT02234622
Last Updated: 2020-03-17
Results Overview
The CAPS is a semi-structured clinician administered interview that measures PTSD diagnostic status and symptom severity consistent with the Diagnostic and Statistical Manual-Fifth Edition. Scores range 0-80 with higher scores meaning a worse outcome.
COMPLETED
NA
212 participants
Change from baseline to 16 weeks (end of treatment)
2020-03-17
Participant Flow
Participant milestones
| Measure |
Holistic Yoga Program
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
|
Wellness Lifestyle Program
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
104
|
|
Overall Study
COMPLETED
|
65
|
68
|
|
Overall Study
NOT COMPLETED
|
43
|
36
|
Reasons for withdrawal
| Measure |
Holistic Yoga Program
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
|
Wellness Lifestyle Program
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
22
|
|
Overall Study
Lost to Follow-up
|
27
|
14
|
Baseline Characteristics
Comparing Effects of a Holistic Yoga Program and a Wellness Program on PTSD Symptoms
Baseline characteristics by cohort
| Measure |
Holistic Yoga Program
n=108 Participants
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
|
Wellness Lifestyle Program
n=101 Participants
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics.
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 12.6 • n=93 Participants
|
51.2 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
50.6 years
STANDARD_DEVIATION 12.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
138 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
129 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
108 Participants
n=93 Participants
|
101 Participants
n=4 Participants
|
209 Participants
n=27 Participants
|
|
Clinician Administered PTSD Scale 5
|
37.1 units on a scale
STANDARD_DEVIATION 8.7 • n=93 Participants
|
36.0 units on a scale
STANDARD_DEVIATION 8.7 • n=4 Participants
|
36.57 units on a scale
STANDARD_DEVIATION 8.71 • n=27 Participants
|
|
PTSD Checklist 5
|
45.2 units on a scale
STANDARD_DEVIATION 12.1 • n=93 Participants
|
45.1 units on a scale
STANDARD_DEVIATION 13.0 • n=4 Participants
|
45.14 units on a scale
STANDARD_DEVIATION 12.51 • n=27 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeks (end of treatment)Population: three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria
The CAPS is a semi-structured clinician administered interview that measures PTSD diagnostic status and symptom severity consistent with the Diagnostic and Statistical Manual-Fifth Edition. Scores range 0-80 with higher scores meaning a worse outcome.
Outcome measures
| Measure |
Holistic Yoga Program
n=108 Participants
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
|
Wellness Lifestyle Program
n=101 Participants
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
|
|---|---|---|
|
Clinician Administered PTSD Scale (CAPS-5)
|
25.8 score on a scale
Standard Deviation 12.1
|
31.0 score on a scale
Standard Deviation 13.0
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeks (end of treatment)Population: three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria
PTSD self-reported symptom severity will be assessed with the PTSD Checklist-5 (PCL-5), a 20-item self-report measure of the 5th version of the Diagnostic and Statistics Manual (DSM-5) symptoms of PTSD used as a measure of change in PTSD symptoms as a function of treatment. Scores range 0-80 with higher scores indicating worse outcome.
Outcome measures
| Measure |
Holistic Yoga Program
n=108 Participants
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
|
Wellness Lifestyle Program
n=101 Participants
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
|
|---|---|---|
|
PTSD Checklist
|
33 score on a scale
Standard Deviation 17.5
|
40.2 score on a scale
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeks (end of treatment)Population: three participants were removed from the analysis when a retrospective audit of the Clinician Administered PTSD Scale revealed they did not meet diagnostic criteria for PTSD
Medical Outcomes Study Sleep Scale (MOS) Problem Index II is a 9-item sub-scale of the 12-item MOS self-report measure that assesses sleep quality (sleep disturbance, adequacy of sleep, and sleep quantity). The item scores of the 9-item sub-scale range from 1-6 and the sub-scale totals are converted to scores ranging 0-100, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Holistic Yoga Program
n=108 Participants
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
|
Wellness Lifestyle Program
n=101 Participants
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
|
|---|---|---|
|
Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II
|
45 score on a scale
Standard Deviation 21.2
|
55 score on a scale
Standard Deviation 20.7
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeks (end of treatment)Population: three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria
PROMIS - short form 5a is a 5-item self-report measure to assess feelings of anger over the past 7 days. Total scores, ranging 5-25 are converted to T-scores with higher scores indicating poorer outcome. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. T-scores range from 0-100
Outcome measures
| Measure |
Holistic Yoga Program
n=108 Participants
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
|
Wellness Lifestyle Program
n=101 Participants
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
|
|---|---|---|
|
Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a
|
57.1 score on a scale
Standard Deviation 8.9
|
58.9 score on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeks (end of treatment)Population: three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria
Depression will be measured by the Beck Depression Inventory (BDI), a 21-item self-report measure, the total score of which ranges 0-63 with higher scores indicating a poorer outcome.
Outcome measures
| Measure |
Holistic Yoga Program
n=108 Participants
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
|
Wellness Lifestyle Program
n=101 Participants
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
|
|---|---|---|
|
Beck Depression Inventory-II
|
17.4 score on a scale
Standard Deviation 12.2
|
18.7 score on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeks (end of treatment)Population: three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria
Anxiety will be measured by the Spielberger State-Trait Anxiety Inventory (STAI), State Anxiety subscale, a self-report instrument consisting of 20-items rated on a 4-point scale (1-4), with a possible range of 20-80. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Holistic Yoga Program
n=108 Participants
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
|
Wellness Lifestyle Program
n=101 Participants
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
|
|---|---|---|
|
Spielberger State-Trait Anxiety (STAI) - State Subscale
|
29.5 score on a scale
Standard Deviation 11
|
27.6 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeks (end of treatment)Population: three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria
Pain will be assessed using the Brief Pain Inventory (BPI), item #3 which is an indicator of average pain severity in the past week. Scores range from 0-10 with higher scores indicating poorer outcome.
Outcome measures
| Measure |
Holistic Yoga Program
n=108 Participants
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
|
Wellness Lifestyle Program
n=101 Participants
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.
|
|---|---|---|
|
Brief Pain Inventory (BPI) Item #3
|
4.9 score on a scale
Standard Deviation 2.7
|
4.9 score on a scale
Standard Deviation 2.9
|
Adverse Events
Holistic Yoga Program
Wellness Lifestyle Program
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place