Clinical trial NCT03059095: Study of Yoga and Mindfulness for Psychological and Physical Wellness
Official title: Study of Yoga and Mindfulness for Psychological and Physical Wellness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Trauma
PTSD
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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 .

Eligibility criteria: 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_____

Primary outcomes:
measure: PCL-5: 20 item checklist for symptoms of PTSD (PCL-5)
timeFrame: Accessing a change from pre, one month, six month and at one year
Secondary outcomes:
measure: PSQI: 15-item Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Accessing a change from pre, one month, six month and at one year
Other outcomes:
measure: POQ: 20-item Pain Outcomes Questionnaire (POQ)
timeFrame: Accessing a change from pre, one month, six month and at one year
Locations:
Study officials:
References: