Stress Disorders, Post-Traumatic
Conditions
Keywords
Stress Disorders, Post-Traumatic, Yoga, Veterans
Brief summary
Given the limited effectiveness of current treatments and the burden PTSD places on Veterans, civilians and clinicians, this research aims to compare the effects of a standardized, traditional, holistic yoga intervention (postures, breathing, deep muscle contraction and relaxation practices) with a wellness program (wellness topics and physical activity) on PTSD symptoms.
Detailed description
Posttraumatic Stress Disorder constitutes a substantial proportion of the burden of illness among Veterans. However, current PTSD treatments are not effective for all, and a significant number remain symptomatic despite pharmacotherapy and psychotherapy. As a result, there has been increased interest within the military and VA in Complementary and Alternative Medicine approaches, such as yoga, to improve symptoms without requiring direct verbal processing of the trauma. Yoga provides an innovative approach to calming hyperarousal, reducing numbness/avoidance, and improving self-regulation of emotions, while cultivating physical and emotional well-being. Because of this unique approach to the biological, psychological, and social dimensions of PTSD, we believe that yoga interventions are poised to meet the demand for more effective PTSD treatment options for Veterans. Recent research indicates that yoga interventions can be delivered successfully to individuals who have PTSD and have the potential to reduce clinician rated and self-reported overall PTSD symptoms, depression and anxiety. However, few studies exist that have evaluated yoga for PTSD and they have involved small sample sizes and are either uncontrolled or waitlist/usual care controlled. Also, there is much variation among studies in the style and components of yoga interventions. Thus, a randomized controlled trial of a standardized, traditional, holistic yoga intervention is urgently needed to inform VA policy makers and clinicians of the potential benefits of yoga as an adjunct to currently available PTSD treatments. OBJECTIVE: The overall goal of this project is to compare the effects of a 16-week Holistic Yoga Program (HYP) with a 16-week Wellness Lifestyle Program (WLP) on PTSD and related symptoms and outcomes. This project has three specific aims: 1) to compare the effects of the interventions (HYP vs. WLP) on overall PTSD symptom severity; 2) compare the interventions' effects on PTSD-specific symptoms (anger, sleep), PTSD-related symptoms (depression, anxiety, pain) and related outcomes (well-being/quality of life); 3) to manualize the Holistic Yoga Program and training process for experienced yoga teachers to deliver HYP to individuals who have PTSD in order to facilitate future study and dissemination efforts. METHODS: This study sample will include 212 outpatients with a clinician-confirmed diagnosis of PTSD, recruited from the Roudebush VA Medical Center as well as metropolitan area mental health clinicians and military/Veterans' organizations, who will be randomly assigned to receive the Holistic Yoga Program (HYP) or the Wellness Lifestyle Program (WLP). The HYP will involve a standardized 16-week intervention consisting of: 1) in-person group yoga class taught by a yoga therapist (Yoga Alliance minimum 200 hour level) with trained assistants.Classes will include (1) yoga postures, breathing practices, deep muscle contraction practices, relaxation practices, and integration of scientific rational and yoga philosophy within the instruction; (2) video and audio recordings for home practice; and 4) a Participant Handbook to reinforce concepts taught during in-person sessions. The WLP is an attention control comprised of low intensity walking and didactics about wellness topics that will also encourage home practice and provide a Participant Handbook to reinforce concepts taught during in-person sessions.
Interventions
BEHAVIORALHolistic Yoga Program
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
BEHAVIORALWellness Lifestyle Program
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Veterans and civilians will be eligible for inclusion if * they are age 18 or older, * have a Clinician Administered PTSD Scale-confirmed PTSD diagnosis, * and access to a working telephone for ease of contact during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS-5) | Change from baseline to 16 weeks (end of treatment) | 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. |
| PTSD Checklist | Change from baseline to 16 weeks (end of treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory-II | Change from baseline to 16 weeks (end of treatment) | 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. |
| Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II | Change from baseline to 16 weeks (end of treatment) | 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. |
| Brief Pain Inventory (BPI) Item #3 | Change from baseline to 16 weeks (end of treatment) | 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. |
| Spielberger State-Trait Anxiety (STAI) - State Subscale | Change from baseline to 16 weeks (end of treatment) | 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. |
| Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a | Change from baseline to 16 weeks (end of treatment) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 108 |
| 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. | 101 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 27 | 14 |
| Overall Study | Withdrawal by Subject | 16 | 22 |
Baseline characteristics
| Characteristic | Wellness Lifestyle Program | Total | Holistic Yoga Program |
|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 13.3 | 50.6 years STANDARD_DEVIATION 12.9 | 49.9 years STANDARD_DEVIATION 12.6 |
| Clinician Administered PTSD Scale 5 | 36.0 units on a scale STANDARD_DEVIATION 8.7 | 36.57 units on a scale STANDARD_DEVIATION 8.71 | 37.1 units on a scale STANDARD_DEVIATION 8.7 |
| PTSD Checklist 5 | 45.1 units on a scale STANDARD_DEVIATION 13 | 45.14 units on a scale STANDARD_DEVIATION 12.51 | 45.2 units on a scale STANDARD_DEVIATION 12.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 65 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 60 Participants | 129 Participants | 69 Participants |
| Region of Enrollment United States | 101 Participants | 209 Participants | 108 Participants |
| Sex: Female, Male Female | 33 Participants | 71 Participants | 38 Participants |
| Sex: Female, Male Male | 68 Participants | 138 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 104 |
| other Total, other adverse events | 0 / 108 | 0 / 104 |
| serious Total, serious adverse events | 0 / 108 | 0 / 104 |
Outcome results
Primary
Clinician Administered PTSD Scale (CAPS-5)
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Holistic Yoga Program | Clinician Administered PTSD Scale (CAPS-5) | 25.8 score on a scale | Standard Deviation 12.1 |
| Wellness Lifestyle Program | Clinician Administered PTSD Scale (CAPS-5) | 31.0 score on a scale | Standard Deviation 13 |
p-value: 0.00295% CI: [-8.2, -1.8]Mixed Models Analysis
Primary
PTSD Checklist
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Holistic Yoga Program | PTSD Checklist | 33 score on a scale | Standard Deviation 17.5 |
| Wellness Lifestyle Program | PTSD Checklist | 40.2 score on a scale | Standard Deviation 15.2 |
p-value: 0.00595% CI: [-10.3, -1.8]Mixed Models Analysis
Secondary
Beck Depression Inventory-II
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Holistic Yoga Program | Beck Depression Inventory-II | 17.4 score on a scale | Standard Deviation 12.2 |
| Wellness Lifestyle Program | Beck Depression Inventory-II | 18.7 score on a scale | Standard Deviation 10.7 |
p-value: 0.63595% CI: [-4.7, 1.9]Mixed Models Analysis
Secondary
Brief Pain Inventory (BPI) Item #3
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Holistic Yoga Program | Brief Pain Inventory (BPI) Item #3 | 4.9 score on a scale | Standard Deviation 2.7 |
| Wellness Lifestyle Program | Brief Pain Inventory (BPI) Item #3 | 4.9 score on a scale | Standard Deviation 2.9 |
p-value: 0.66895% CI: [-0.5, 1]Mixed Models Analysis
Secondary
Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Holistic Yoga Program | Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II | 45 score on a scale | Standard Deviation 21.2 |
| Wellness Lifestyle Program | Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II | 55 score on a scale | Standard Deviation 20.7 |
p-value: 0.04295% CI: [-11.9, -1.6]Mixed Models Analysis
Secondary
Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a
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
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Holistic Yoga Program | Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a | 57.1 score on a scale | Standard Deviation 8.9 |
| Wellness Lifestyle Program | Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a | 58.9 score on a scale | Standard Deviation 9.2 |
p-value: 0.48295% CI: [-4.2, 1.1]Mixed Models Analysis
Secondary
Spielberger State-Trait Anxiety (STAI) - State Subscale
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Holistic Yoga Program | Spielberger State-Trait Anxiety (STAI) - State Subscale | 29.5 score on a scale | Standard Deviation 11 |
| Wellness Lifestyle Program | Spielberger State-Trait Anxiety (STAI) - State Subscale | 27.6 score on a scale | Standard Deviation 11.6 |
p-value: 0.36795% CI: [-6, 1.1]Mixed Models Analysis