Clinical Trial: Study of Yoga and Mindfulness for Psychological and Physical Wellness

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Study of Yoga and Mindfulness for Psychological and Physical Wellness

Brief Summary: 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.

Detailed Summary:

Yoga is an ancient Indian science and way of life that includes the practice of specific postures, regulated breathing, and meditation. It is designed to bring balance and health to the physical, mental, emotional, and spiritual dimensions of the individual.

A recent systematic review of 17 studies published between the years 2011-2013 reported that most studies of yoga demonstrated positive changes in psychological or physiological outcomes related to stress. In addition, the practice of yoga also seems to be associated with moderate improvements in cognitive function , which in turn, may be expected to positively impact overall psychological well-being. These selected results provide a strong rationale to examine the effects of yoga for a range of health conditions, in addition to across various setting and by use of different delivery methods.

Much of the research on mindfulness has been in the area of anxiety and depression. Evidence suggests that mindfulness-based stress reduction, an intervention that teaches individuals to attend to the present moment in a nonjudgmental, accepting manner , can result in reduced symptoms of depression and anxiety .


Sponsor: University of South Florida

Current Primary Outcome: PCL-5: 20 item checklist for symptoms of PTSD (PCL-5) [ Time Frame: Accessing a change from pre, one month, six month and at one year ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: PSQI: 15-item Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Accessing a change from pre, one month, six month and at one year ]

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.


Original Secondary Outcome: Same as current

Information By: University of South Florida

Dates:
Date Received: February 10, 2017
Date Started: September 1, 2016
Date Completion: September 1, 2018
Last Updated: February 21, 2017
Last Verified: February 2017