Study of Yoga and Mindfulness for Psychological and Physical Wellness
Primary Purpose
Psychological Trauma, PTSD
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yoga & Meditation
Sponsored by
About this trial
This is an interventional treatment trial for Psychological Trauma
Eligibility Criteria
Inclusion/Exclusion Form
ID# __________ Visit: Screening Date: ____________________
Inclusion Criteria (all must be marked "Yes" to be eligible for the study).
- Age 18 years or older and military service member active duty or retired Yes ___ No ___
- Access to a computer and internet service Yes ___ No ___
- Able to read English at 8th grade level or higher. Yes ___ No ___
- 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_____
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yoga and Meditation
Arm Description
Yoga and Meditation online sessions 2x's a week.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03059095
First Posted
February 10, 2017
Last Updated
July 27, 2020
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT03059095
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Trauma, PTSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
335 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga and Meditation
Arm Type
Experimental
Arm Description
Yoga and Meditation online sessions 2x's a week.
Intervention Type
Behavioral
Intervention Name(s)
Yoga & Meditation
Intervention Description
Yoga is an ancient Indian science and way of life that includes the practice of specific postures, regulated breathing, and meditation.mindfulness-based stress reduction, an intervention that teaches individuals to attend to the present moment in a nonjudgmental, accepting manner
Primary Outcome Measure Information:
Title
PCL-5: 20 item checklist for symptoms of PTSD (PCL-5)
Description
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.
Time Frame
Accessing a change from pre, one month, six month and at one year
Secondary Outcome Measure Information:
Title
PSQI: 15-item Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Accessing a change from pre, one month, six month and at one year
Other Pre-specified Outcome Measures:
Title
POQ: 20-item Pain Outcomes Questionnaire (POQ)
Description
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)
Time Frame
Accessing a change from pre, one month, six month and at one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion/Exclusion Form
ID# __________ Visit: Screening Date: ____________________
Inclusion Criteria (all must be marked "Yes" to be eligible for the study).
Age 18 years or older and military service member active duty or retired Yes ___ No ___
Access to a computer and internet service Yes ___ No ___
Able to read English at 8th grade level or higher. Yes ___ No ___
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_____
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://yogaformen.com/pages/yoga-for-veterans
Description
study is all online
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Study of Yoga and Mindfulness for Psychological and Physical Wellness
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