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Comparing Effects of a Holistic Yoga Program and a Wellness Program on PTSD Symptoms
NA trial testing Holistic Yoga Program in Stress Disorders, Post-Traumatic in 212 participants. Completed in 9 August 2018.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 212 |
| Start date | 3 August 2015 |
| Primary completion | 9 August 2018 |
| Estimated completion | 9 August 2018 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
18 and older, any sex, with Stress Disorders, Post-Traumatic. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Holistic Yoga Program | 25.8 | ± 12.1 |
| Wellness Lifestyle Program | 31.0 | ± 13.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Holistic Yoga Program | 33 | ± 17.5 |
| Wellness Lifestyle Program | 40.2 | ± 15.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Holistic Yoga Program | 45 | ± 21.2 |
| Wellness Lifestyle Program | 55 | ± 20.7 |
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
| Group | Value | 95% CI |
|---|---|---|
| Holistic Yoga Program | 57.1 | ± 8.9 |
| Wellness Lifestyle Program | 58.9 | ± 9.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Holistic Yoga Program | 17.4 | ± 12.2 |
| Wellness Lifestyle Program | 18.7 | ± 10.7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Holistic Yoga Program | 29.5 | ± 11 |
| Wellness Lifestyle Program | 27.6 | ± 11.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Holistic Yoga Program | 4.9 | ± 2.7 |
| Wellness Lifestyle Program | 4.9 | ± 2.9 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02234622.
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