PTSD Clinical Trial
Official title:
Study of Yoga and Mindfulness for Psychological and Physical Wellness
Verified date | July 2020 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study rationale is to analyze the extent to which adult U.S. or non U.S. veterans or active duty military personnel who participate in the Yoga for Men (YfM) online Yoga and meditation classes report changes in symptoms of psychological trauma, depression, anxiety, stress, sleep quality, and pain. The serial measurement of symptom status over a 12-month period will provide information on the trajectory of change in symptom status, as well as insight into the extent to which this program may be an effective modality for veterans and service members who are experiencing symptoms of psychological trauma, depression, anxiety, stress, sleep quality, and pain. The purpose of this study is to evaluate whether the existing YfM online program is helpful to study qualifying veterans with symptoms of PTSD and related conditions.
Status | Completed |
Enrollment | 335 |
Est. completion date | September 1, 2018 |
Est. primary completion date | September 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion/Exclusion Form ID# __________ Visit: Screening Date: ____________________ Inclusion Criteria (all must be marked "Yes" to be eligible for the study). 1. Age 18 years or older and military service member active duty or retired Yes ___ No ___ 2. Access to a computer and internet service Yes ___ No ___ 3. Able to read English at 8th grade level or higher. Yes ___ No ___ 4. One or more symptoms endorsed on Appendix B. Yes ___ No ___ Exclusion Criteria (must be marked "No" to be eligible for the study). 1. Never served in the military. Yes ___ No ___ Is Subject eligible for participation? Yes_____ No_____ |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of South Florida |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | POQ: 20-item Pain Outcomes Questionnaire (POQ) | Short Form is a reliable and valid instrument that contains 19 primary pain items that are rated on an 11-point (0-10) Likert-type scale and one demographic question. In addition to a total pain score, six subscale scores can be calculated that correspond to: pain intensity (1 item), pain-related impairment in mobility (4 items), pain-related impairment in performing activities of daily living (4 items), sense of impairment in activity and energy levels (3 items), dysphoric affect and associated symptoms (5 items), and pain-related fear and avoidance (2 items) | Accessing a change from pre, one month, six month and at one year | |
Primary | PCL-5: 20 item checklist for symptoms of PTSD (PCL-5) | There are several different ways of interpreting the scores given by the PTSD Checklist-5.[5] For a person to have a probable diagnosis of PTSD sufficient criteria must be at least moderately met in each of the four symptom groups.[1] This means you need to have one or more symptoms from questions 1 to 5, either question 6 or 7, two or more from questions 8 to 14, and two or more from questions 15 to 20, each of which must be met moderately, quite a bit or extremely.[1] In addition, a score of 38 or higher indicates probable PTSD in veterans. | Accessing a change from pre, one month, six month and at one year | |
Secondary | PSQI: 15-item Pittsburgh Sleep Quality Index (PSQI) | measures quality and patterns of sleep in adults. It takes an estimated 3 to 6 minutes to complete. A global PSQI score greater than 5 has yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p<0.001) in distinguishing good and poor sleepers. Internal consistency reliability has been estimated to range from .77 to .81. | Accessing a change from pre, one month, six month and at one year |
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