Stress Disorders, Post-Traumatic Clinical Trial
— RELIEVEOfficial title:
Outcomes of a Holistic Yoga Program Designed to Relieve PTSD (RELIEVE Trial)
NCT number | NCT02234622 |
Other study ID # | D1487-R |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 3, 2015 |
Est. completion date | August 9, 2018 |
Verified date | March 2020 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 212 |
Est. completion date | August 9, 2018 |
Est. primary completion date | August 9, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. Exclusion Criteria: Exclusion criteria will include: - severe medical conditions in which yoga is contraindicated; - active psychosis; - active suicidal intent; - moderate to severe cognitive impairment as determined by the short Mini-Mental State Examination, a six-item screener (MMSE); - involvement in ongoing yoga classes and/or regular home practice of yoga in the previous 3 months; - and receiving ongoing medical or psychological treatment that includes more than one hour weekly of relaxation and mind-body based stress reduction strategies (related directly to meditation and yoga). |
Country | Name | City | State |
---|---|---|---|
United States | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Change from baseline to 16 weeks (end of treatment) | |
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. | Change from baseline to 16 weeks (end of treatment) | |
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. | Change from baseline to 16 weeks (end of treatment) | |
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 | Change from baseline to 16 weeks (end of treatment) | |
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. | Change from baseline to 16 weeks (end of treatment) | |
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. | Change from baseline to 16 weeks (end of treatment) | |
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. | Change from baseline to 16 weeks (end of treatment) |
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